Kidney Failure, Chronic Therapy; HemodialysisPhase 1NCT01920854

A Single Ascending Dose Study of Soluble Ferric Pyrophosphate Administered Intravenously in Healthy Volunteers.

A Phase 1 study testing soluble ferric pyrophosphate in people with Kidney Failure, Chronic Therapy; Hemodialysis, run by Rockwell Medical Technologies, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine the pharmacokinetics of fixed ascending doses of intravenously administered Soluble Ferric Pyrophosphate Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Kidney Failure, Chronic Therapy; Hemodialysis
What is being tested?: soluble ferric pyrophosphate
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 1 siteUnited States
Study dates: Jun 2013to Sep 2013
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Age 18-55 inclusive at the time of consent. This inclusion criterion will only be assessed at the first screening visit.
Male or non-pregnant, non-lactating female who is at least 90 days post-partum.
Subject is willing to comply with any applicable contraceptive requirements of the protocol.
Satisfactory medical assessment with no clinically significant or relevant abnormalities in medical history, physical examination (PE), vital signs, electrocardiogram (ECG) and laboratory evaluation (hematology, biochemistry, urinalysis) as assessed by the Investigator.
An understanding, ability and willingness to fully comply with study procedures and restrictions.
Ability to provide written, personally signed and dated informed consent to participate in the study, in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations, before completing any study-related procedures.
Body Mass Index (BMI) between 20.0 and 32.0 kg/m² inclusive. This inclusion criterion will only be assessed at the first screening visit.
Subjects must agree to discontinue all iron preparations for 14 days prior to study drug administration.

Who cannot join

Current or recurrent disease (e.g. cardiovascular, renal, liver, gastro-intestinal, malignancy or other conditions) that could affect the action, absorption or disposition of the investigational product utilized in this study, or could affect clinical or laboratory assessments.
Hemoglobin < 11 g/dL or Hematocrit < 30%.
Serum iron concentration ≤ 70 µg/dL (male or female).
Current or relevant previous history of physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or study procedures.
Significant illness, as judged by the investigator, within 2 weeks of the first dose of investigational product.
Current use of any medication (including prescription, over the counter [OTC], herbal or homeopathic preparations) within 14 days of first dose of investigational product. Exceptions are hormonal replacement therapy, hormonal contraceptives, acetaminophen and non-steroidal anti-inflammatory drugs.

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Known or suspected intolerance or hypersensitivity to iron containing product(s).
History of alcohol or other substance abuse within the last year.
A positive screen for cotinine, alcohol or drugs of abuse.
Male subjects who consume more than 21 units of alcohol per week or three units per day. Female subjects who consume more than 14 units of alcohol per week or two units per day. 1 alcohol unit =1 beer = 1 wine (5oz) = 1 liquor (1.5 oz.).
A history of a positive human immunodeficiency virus (HIV) antibody screen, Hepatitis B surface antigen (HBsAg) or Hepatitis C virus (HCV) antibody screen.
Use of tobacco in any form (e.g., smoking or chewing) or other nicotine-containing products in any form (e.g. gum, patch). Ex-users must report that they have stopped using tobacco for at least 30 days prior to receiving the first dose of investigational product.
Routine consumption of more than five units of caffeine per day or subjects who experience caffeine withdrawal headaches. One caffeine unit is contained in the following items: one 6-oz. cup of coffee, two 12-oz. cans of cola, one 12-oz. cup of tea, three 1-oz. chocolate bars.
Donation of blood or blood products (e.g., plasma or platelets) within 60 days prior to receiving the first dose of investigational product.
Use of another investigational product within 30 days prior to receiving the first dose of investigational product or active enrolment in another drug or vaccine clinical study.
Pregnancy or intention to become pregnant before completing all study drug treatment.
Current medical status that, in the investigators opinion, would preclude participation in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Kalamazoo, Michigan, 49007

Other trials in United States

About this study

Official title: A Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study of Intravenously Administered SFP in Healthy Volunteers

The purpose of this study is to determine the pharmacokinetics of fixed ascending doses of intravenously administered Soluble Ferric Pyrophosphate

Read the detailed description

A total of 48 healthy volunteers will be studied.
Depending on the safety profile at completion of the highest dose cohort, an additional 2 cohorts of subjects may be studied.
Doses of SFP may be modified, depending on the PK and safety findings at each dose level.
Cohorts may be dropped for safety or tolerability after discussion with the sponsor.
There will be 6 active and 2 placebo subjects in each study cohort.
Subjects in Cohorts 1-3 will receive ascending doses of SFP by intravenous infusion over 4 hours.
Subjects in Cohorts 4-6 will receive ascending doses of SFP by intravenous infusion over 12 hours.

All subjects will be confined in the CRC for 1 day prior to study drug administration and for 2 additional days for safety assessments and completion of test procedures.

Conditions: Kidney Failure, Chronic Therapy; Hemodialysis
Being tested: soluble ferric pyrophosphate, Placebo
Keywords: Soluble Ferric Pyrophosphate, Pharmacokinetics, Iron, Hemodialysis
Medical subject headings: Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

soluble ferric pyrophosphateDrug
Also called SFP
PlaceboDrug

Study groups in NCT01920854
Study group	Role	What they receive
Soluble Ferric Pyrophosphate	Experimental	Group/Cohort Designation: Ascending doses of SFP. Each subject will receive a defined dose of SFP IV administered under double-blind conditions. Pharmacokinetics of iron will be measured using a validated assay for iron and transferrin bound iron. Receives: Drug: soluble ferric pyrophosphate
Control	Placebo comparator	Group/Cohort Designation: Each subject will receive placebo IV administered under double-blind conditions. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)
Serum iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Serum iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Measured: 48 hours
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected)
Serum iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Serum iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Measured: 48 hours
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)
Samples for transferrin-bound iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin-bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Measured: 48 hours
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected)
Samples for transferrin-bound iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin-bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Measured: 48 hours
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute)
Samples for total iron binding capacity for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for total iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Measured: 48 hours
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute)
Samples for total iron binding capacity for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for total iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Measured: 48 hours
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected)
Samples for non-transferrin bound iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for non-transferrin bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Measured: 48 hours
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected)
Samples for non-transferrin bound iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for non-transferrin bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Measured: 48 hours
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
Samples for unbound iron binding capacity for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for unbound iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Measured: 48 hours
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
Samples for unbound iron binding capacity for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for unbound iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Measured: 48 hours
Baseline Transferrin Profile: Cohorts 1, 2, 3, 4, 5, 6
The mean baseline transferrin will be calculated based on samples drawn just prior to infusion for all Cohorts (both SFP and placebo)
Measured: Baseline (1 day)

Secondary outcomes (11)

Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated)
Samples for transferrin saturation for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin saturation for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Measured: 48 hours
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated)
Samples for transferrin saturation for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin saturation for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours.
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Measured: 48 hours
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last)
Samples for three area under the curve (AUC) calculations (AUC 0-12, AUC 0 - 4, and AUC last) were collected for all Cohorts (both SFP and placebo).
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Measured: 48 hours
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] Inf)
Samples for area under the curve from time-zero extrapolated to infinity (AUC inf) calculations were collected for all Cohorts (just those subjects that received SFP).
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Measured: 48 hours
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean CL [Clearance])
Samples for Clearance (CL) calculations were collected for all Cohorts (just those subjects that received SFP).
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Measured: 48 hours
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (C Max)
Samples maximal baseline corrected concentration of iron (Cmax) calculations were collected for all Cohorts (both SFP and placebo).
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Measured: 48 hours
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Tmax)
Samples for observed time to reach maximum iron concentration (Tmax) calculations were collected for all Cohorts (both SFP and placebo).
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Measured: 48 hours
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Cmax/Dose)
Samples for the dose-normalized maximal baseline corrected concentration of iron (Cmax/dose) calculations were collected for all Cohorts (just those subjects that received SFP).
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Measured: 48 hours
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Lambda z)
Samples for terminal phase rate constant (lambda z) calculations were collected for all Cohorts (just those subjects that received SFP).
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Measured: 48 hours
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Half Life: t 1/2)
Samples for terminal phase half life (t 1/2) calculations were collected for all Cohorts (just those subjects that received SFP).
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Measured: 48 hours
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Vz)
Samples for volume of distribution in the terminal elimination phase (Vz) calculations were collected for all Cohorts (just those subjects that received SFP).
There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2013Sep 2013

First posted12 Aug 2013 (estimated)
Study startJun 2013
Primary completionSep 2013
Study completionSep 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Kidney Failure, Chronic Therapy; HemodialysisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01920854
Sponsor's protocol ID: RMTI-SFP-9
Status last verified: Jan 2015
First submitted: 28 Jun 2013
Last updated: 26 Jan 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Web-based Advance Care Planning Intervention for Patients With Kidney Failure on Dialysis: Pilot Testing of 'My Voice'
Kidney Failure, Chronic Therapy; Hemodialysis

All Kidney Failure, Chronic Therapy; Hemodialysis trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study of Intravenously Administered SFP in Healthy Volunteers
ClinicalTrials.gov ID: NCT01920854
Acronym / sponsor ID: RMTI-SFP-9
Conditions: Kidney Failure, Chronic Therapy; Hemodialysis
Keywords: Soluble Ferric Pyrophosphate, Pharmacokinetics, Iron, Hemodialysis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Rockwell Medical Technologies, Inc.Industry (pharma, biotech, devices)
Study start: Jun 2013
Primary completion: Sep 2013 (actual)
Study completion: Sep 2013 (actual)
First posted: 12 Aug 2013 (estimated)
Results: Posted 19 Dec 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine the pharmacokinetics of fixed ascending doses of intravenously administered Soluble Ferric Pyrophosphate

Detailed description

A total of 48 healthy volunteers will be studied.
Depending on the safety profile at completion of the highest dose cohort, an additional 2 cohorts of subjects may be studied.
Doses of SFP may be modified, depending on the PK and safety findings at each dose level.
Cohorts may be dropped for safety or tolerability after discussion with the sponsor.
There will be 6 active and 2 placebo subjects in each study cohort.
Subjects in Cohorts 1-3 will receive ascending doses of SFP by intravenous infusion over 4 hours.
Subjects in Cohorts 4-6 will receive ascending doses of SFP by intravenous infusion over 12 hours.

All subjects will be confined in the CRC for 1 day prior to study drug administration and for 2 additional days for safety assessments and completion of test procedures.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Soluble Ferric Pyrophosphate	Experimental	Drug: soluble ferric pyrophosphateGroup/Cohort Designation: Ascending doses of SFP. Each subject will receive a defined dose of SFP IV administered under double-blind conditions. Pharmacokinetics of iron will be measured using a validated assay for iron and transferrin bound iron.
Control	Placebo comparator	Drug: PlaceboGroup/Cohort Designation: Each subject will receive placebo IV administered under double-blind conditions.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Age 18-55 inclusive at the time of consent. This inclusion criterion will only be assessed at the first screening visit.
Male or non-pregnant, non-lactating female who is at least 90 days post-partum.
Subject is willing to comply with any applicable contraceptive requirements of the protocol.
Satisfactory medical assessment with no clinically significant or relevant abnormalities in medical history, physical examination (PE), vital signs, electrocardiogram (ECG) and laboratory evaluation (hematology, biochemistry, urinalysis) as assessed by the Investigator.
An understanding, ability and willingness to fully comply with study procedures and restrictions.

Key exclusion criteria (17 listed)

Current or recurrent disease (e.g. cardiovascular, renal, liver, gastro-intestinal, malignancy or other conditions) that could affect the action, absorption or disposition of the investigational product utilized in this study, or could affect clinical or laboratory assessments.
Hemoglobin < 11 g/dL or Hematocrit < 30%.
Serum iron concentration ≤ 70 µg/dL (male or female).
Current or relevant previous history of physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or study procedures.
Significant illness, as judged by the investigator, within 2 weeks of the first dose of investigational product.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
soluble ferric pyrophosphateAlso: SFP	Drug	Soluble Ferric Pyrophosphate
Placebo	Drug	Control

Primary outcome

Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)
Time frame: 48 hours
Serum iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Serum iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected)
Time frame: 48 hours
Serum iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Serum iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)
Time frame: 48 hours
Samples for transferrin-bound iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin-bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected)
Time frame: 48 hours
Samples for transferrin-bound iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for transferrin-bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Iron Binding Capacity, Absolute)
Time frame: 48 hours
Samples for total iron binding capacity for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for total iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Iron Binding Capacity, Absolute)
Time frame: 48 hours
Samples for total iron binding capacity for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for total iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Non-transferrin Bound Iron, Baseline Corrected)
Time frame: 48 hours
Samples for non-transferrin bound iron for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for non-transferrin bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Non-transferrin Bound Iron, Baseline Corrected)
Time frame: 48 hours
Samples for non-transferrin bound iron for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for non-transferrin bound iron for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
Time frame: 48 hours
Samples for unbound iron binding capacity for Cohorts 1-3, 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for unbound iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Unbound Iron Binding Capacity, Baseline Corrected)
Time frame: 48 hours
Samples for unbound iron binding capacity for Cohorts 1-3 and 6 will be collected at 0, 0.5,1, 2, 3, 4, 4.5, 5, 6, 7, 7.5, 8, 9,10, 12,12.5 14, 16, 20, 24,36, and 48 hours. Samples for unbound iron binding capacity for Cohorts 4 and 5 will be collected at 0, 0.5,1, 2, 4, 6, 9, 12,12.5, 14,16,18,20, 24, 30, 36, and 48 hours. There was no formal sample size calculation for this study; 48 subjects were enrolled and 48 subjects were analyzed to establish the PK profile of the serum iron from SFP. Study results were summarized by dose group, with descriptive statistics. No additional statistical testing was performed. No imputation of missing data was performed. No windowing of visits was performed.
Baseline Transferrin Profile: Cohorts 1, 2, 3, 4, 5, 6
Time frame: Baseline (1 day)
The mean baseline transferrin will be calculated based on samples drawn just prior to infusion for all Cohorts (both SFP and placebo)

11 secondary outcomes

Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Absolute Transferrin Saturation, Calculated)
Time frame: 48 hours
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Absolute Transferrin Saturation, Calculated)
Time frame: 48 hours
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] 0 - 12, Mean AUC 0 - 4, Mean AUC Last)
Time frame: 48 hours
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean AUC [Area Under the Curve] Inf)
Time frame: 48 hours
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean CL [Clearance])
Time frame: 48 hours
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (C Max)
Time frame: 48 hours
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Tmax)
Time frame: 48 hours
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Cmax/Dose)
Time frame: 48 hours
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Lambda z)
Time frame: 48 hours
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Half Life: t 1/2)
Time frame: 48 hours
Serum Iron Profile From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 4, 5, 6 (Mean Vz)
Time frame: 48 hours

Results and safety

Results posted to the registry on 19 Dec 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohorts 1 - 6 Placebo	12	11
Cohort 1 SFP	6	6
Cohort 2 SFP	6	6
Cohort 3 SFP	6	6
Cohort 4 SFP	6	5
Cohort 5 SFP	6	6
Cohort 6 SFP	6	5

Primary outcome: Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)

Time frame: 48 hours. Mean (Standard Deviation). Unit: micrograms/dL

Measure	Cohorts 1 - 3, 6 Placebo n = 8	Cohort 1 SFP n = 6	Cohort 2 SFP n = 6	Cohort 3 SFP n = 6	Cohort 6 SFP n = 6
t = 0 hrs	18.87125 (19.08355)	14.625 (13.54503)	20.13333 (9.256061)	14.806 (10.09701)	31.73333 (17.07579)
t = 0.5 hrs	19.25243 (12.97435)	22.075 (15.44849)	33.21167 (16.22149)	41.53333 (17.55844)	58.65 (21.0115)
t = 1 hr	23.555 (16.79989)	40.34 (14.2365)	47.45 (19.26954)	67.24 (29.08003)	95.21667 (18.84658)
t = 2 hrs	32.54286 (32.58808)	73.15 (62.48)	88.28333 (22.29039)	119.34 (46.55242)	150.3333 (22.43806)
t = 3 hrs	41.3125 (31.5142)	77.64 (25.54981)	112.7333 (29.95721)	173.4 (17.38678)	210 (26.54807)
t = 4 hrs	43.75 (39.09914)	82.76 (10.01489)	143.4167 (33.93585)	206 (37.76242)	241.5 (25.6963)
t = 4.5 hrs	46.99 (33.692)	94.38 (12.827)	150.8 (39.0858)	196.25 (46.29885)	258.3333 (32.20973)
t = 5 hrs	50.74714 (39.71965)	88.88 (30.95007)	135.26 (40.90584)	207.5 (41.23469)	238.1667 (27.28675)

Population analysed: The PK Population was defined as all subjects receiving a dose of SFP or placebo who had sufficient post-dose blood samples taken to estimate PK parameters for serum iron endpoints. All 48 enrolled subjects were included in the PK Population.

Primary outcome: Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected)

Time frame: 48 hours. Mean (Standard Deviation). Unit: micrograms/dL

Measure	Cohorts 4 and 5 Placebo n = 4	Cohort 4 SFP n = 6	Cohort 5 SFP n = 6
t = 0 hrs	22.575 (8.144272)	15.55 (11.59451)	7.888333 (33.94121)
t = 0.5 hrs	21.7 (13.11602)	26.25 (13.70631)	29.97167 (33.57264)
t = 1 hr	23 (11.37629)	49.46667 (12.52576)	68.23333 (44.6479)
t = 2 hrs	24.9325 (17.2084)	77.62 (17.82826)	107.6333 (43.33413)
t = 4 hrs	41.16667 (32.85869)	140.2 (19.84187)	197.6667 (46.28031)
t = 6 hrs	42.975 (36.03807)	168.8 (35.75891)	232 (48.90808)
t = 9 hrs	17.6 (41.26835)	167.2 (42.3757)	228.8333 (44.96851)
t = 12 hrs	2.175 (29.20575)	176 (43.28972)	214.5 (49.31835)

Primary outcome: Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)

Time frame: 48 hours. Mean (Standard Deviation). Unit: micrograms/dL

Measure	Cohorts 1 - 3, 6 Placebo n = 8	Cohort 1 SFP n = 6	Cohort 2 SFP n = 6	Cohort 3 SFP n = 6	Cohort 6 SFP n = 6
t = 0 hrs	15.81588 (15.29313)	27.45 (10.6442)	24.76667 (12.58438)	18.03333 (13.6192)	34.47833 (22.29513)
t = 0.5 hrs	16.12875 (16.956)	36.86667 (8.992145)	46.41667 (11.35067)	48.3 (16.06275)	62.93333 (20.16231)
t = 1 hr	24.04125 (23.55888)	51.73333 (10.18797)	70.8 (14.34489)	81.31667 (21.66614)	102.8 (22.60044)
t = 2 hrs	26.3875 (17.3591)	69.25 (11.37853)	112.55 (17.88449)	142.9 (27.52417)	166.6667 (22.00606)
t = 3 hrs	36.7375 (24.39203)	96.06667 (17.22355)	1148.3333 (26.3717)	194.3333 (39.70222)	223.6667 (21.58394)
t = 4 hrs	42.5375 (27.70637)	111.4167 (21.85437)	179.1667 (35.79618)	229.8333 (58.21483)	247.8333 (28.47045)
t = 4.5 hrs	46.3125 (26.86966)	113 (10.55936)	183.5 (37.35639)	230.5 (54.47844)	259.1667 (36.66833)
t = 5 hrs	47.8375 (31.67153)	105.95 (21.48299)	171.3333 (34.4248)	240.6667 (42.41541)	241.8333 (21.80291)

Primary outcome: Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected)

Time frame: 48 hours. Mean (Standard Deviation). Unit: micrograms/dL

Measure	Cohorts 4 and 5 Placebo n = 4	Cohort 4 SFP n = 6	Cohort 5 SFP n = 6
t = 0 hrs	26.675 (10.10095)	17.13333 (13.10836)	22.31167 (25.13075)
t = 0.5 hrs	24.6 (12.80989)	32.36667 (14.44322)	46.76667 (25.7235)
t = 1 hr	31.35 (14.11772)	56.01667 (12.43309)	80.48333 (26.35234)
t = 2 hrs	35.75 (16.21532)	93.36667 (16.01058)	136.3333 (27.94041)
t = 4 hrs	50.9 (26.83927)	152 (14.02854)	222.5 (41.28801)
t = 6 hrs	55 (38.45179)	186.8 (27.12379)	255.5 (51.20059)
t = 9 hrs	24.285 (43.9688)	181.3333 (34.92659)	254.5 (60.24201)
t = 12 hrs	-0.975 (28.42761)	178.5 (47.26415)	236.8333 (62.58887)

11 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohorts 1 - 6 Placebo	0 of 12 (0%)	3 of 12 (25%)	Not reported
Cohort 1 SFP	0 of 6 (0%)	0 of 6 (0%)	Not reported
Cohort 2 SFP	0 of 6 (0%)	3 of 6 (50%)	Not reported
Cohort 3 SFP	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
Cohort 4 SFP	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
Cohort 5 SFP	0 of 6 (0%)	0 of 6 (0%)	Not reported
Cohort 6 SFP	0 of 6 (0%)	0 of 6 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Kidney Failure, Chronic Therapy; Hemodialysis

Recruiting
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Kidney Failure, Chronic Therapy; Hemodialysis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Raymond D Pratt, MD FACP study director

Rockwell Medical Inc

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing soluble ferric pyrophosphate in people with Kidney Failure, Chronic Therapy; Hemodialysis, run by Rockwell Medical Technologies, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Dec 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected) (time frame: 48 hours). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01920854.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2015; AzTrials last refreshed its copy on 6 Nov 2026.

Trial summary

Key requirements

Who may be able to join

Who cannot join

Trial locations and contacts

About this study

What participants receive

What is being measured

Timeline

Resources

More details

Study at a glance

Clinical summary

Study design

Who may qualify

Key inclusion criteria (8 listed)

Key exclusion criteria (17 listed)

Interventions

Primary outcome

Results and safety

Participant flow

Primary outcome: Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)

Primary outcome: Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected)

Primary outcome: Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)

Primary outcome: Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected)

Adverse events

Research links

Related trials for Kidney Failure, Chronic Therapy; Hemodialysis

Web-based Advance Care Planning Intervention for Patients With Kidney Failure on Dialysis: Pilot Testing of 'My Voice'

Referral and contact

Questions about this trial

Participant flow

Primary outcome: Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Total Serum Iron, Baseline Corrected)

Primary outcome: Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Total Serum Iron, Baseline Corrected)

Primary outcome: Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 1, 2, 3, 6 (Mean Transferrin-bound Iron, Baseline Corrected)

Primary outcome: Pharmacokinetics of Iron From Soluble Ferric Pyrophosphate: Cohorts 4, 5 (Mean Transferrin-bound Iron, Baseline Corrected)

Adverse events