End Stage Renal DiseasePhase 1/2NCT02595437

Triferic Pediatric Pharmacokinetic Protocol

A Phase 1/2 study testing Triferic in people with End Stage Renal Disease, run by Rockwell Medical Technologies, Inc. at 9 sites 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 main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered intravenously in pediatric patients with chronic kidney disease on chronic hemodialysis (CKD-5HD). It is an open-label, two-period sequential dosing study. Read more about this study

Who is it for?: Ages Up to 17 years
Conditions the study is for: End Stage Renal Disease
What is being tested?: Triferic
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 9 sitesUnited States
Study dates: 1 Nov 2015to Jan 2017
Phase: Phase 1/2
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 Up to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

A patient will be eligible for inclusion in the study only if all of the following criteria are met:
Parents/legal guardians of the patient have the ability to understand the requirements of the study and have demonstrated a willingness to have their child comply with all study procedures by signing an institutional review board-approved informed consent form. Where applicable, assent of the patient has also been obtained for all study procedures prior to any study-related activities.
Patient is <18 years of age at screening.
Patient has chronic kidney disease receiving in-center hemodialysis at least twice weekly for at least 1 month prior to screening.
Patient is receiving adequate hemodialysis as assessed by the investigator and based on a single pool Kt/V measurement >1.2.
Patient has a vascular access (tunneled catheter, AV fistula or AV graft) suitable to support blood flows for hemodialysis treatment.

Show all 13Show fewer

Patient has a body mass of 11 lbs (5 kg).
Patient is iron-replete as measured by a TSAT 20% and a ferritin >100 micrograms/L at screening.
Patient has a whole blood Hgb concentration of 10.0 g/dL at screening.
If patient is receiving ESA, the dose has been stable (unchanged) for at least 3 weeks prior to Baseline admission.
Patient has appropriate laboratory values for their disease state at screening (per investigator judgment).
Patient has no significant abnormal findings on physical examination that would preclude participation in the study.
If the patient is female, she must be pre-pubertal, have had documented surgical sterilization prior to Baseline admission, or be practicing adequate birth control. All female patients 9 years of age and older, and also any who have reached menarche before age 9 years, must have a negative serum pregnancy test during screening. It is the investigator's responsibility to determine whether the patient has adequate birth control for study participation.

Who cannot join

A patient will not be eligible for inclusion in the study if any of the following criteria apply:
Patient is positive for human immunodeficiency virus (HIV) or hepatitis B by history.
Patient has an acute illness within 1 week of Baseline admission (patient may be screened again 2 weeks post resolution of the acute illness).
Patient is receiving intravenous or oral antibiotics or antifungals for any infectious process. Prophylactic antibiotics administered on a regular basis are allowed.
Patient has evidence of an ongoing active inflammatory process (e.g., systemic lupus erythematosus, acute or chronic active hepatitis, etc.).
Patient has participated in an investigational drug study within the 30 days prior to Baseline admission.
Administration of IV or oral iron supplements within 2 weeks prior to Baseline admission.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Children's Hospital of Alabama
Birmingham, Alabama, 35233
Cincinnati Children's Hospital and Medical Center
Cincinnati, Ohio, 45229
Joe DiMagggio Children's Hospital/Memorial Regional Hospital
Hollywood, Florida, 33021
Childrens Mercy Hospital
Kansas City, Missouri, 64108
Loma Linda University Hospital
Loma Linda, California, 92354
Jackson Memorial Hospital
Miami, Florida, 33136
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Lucile Packard Childrens Hospital
Stanford, California, 94305
Nemours/A. I. DuPont Hospital for Children
Wilmington, Delaware, 19803

Other trials in United States

About this study

Official title: Pharmacokinetics of Triferic (Ferric Pyrophosphate Citrate) Administered Via Dialysate and IV to Pediatric Patients on Chronic Hemodialysis

Read the detailed description

This is a Phase 1/2, open-label, 2-period, single-dose study assessing the safety and pharmacokinetics (PK) of Triferic (ferric pyrophosphate citrate, or FPC) administered via dialysate and IV to pediatric patients (< 18 years of age) receiving chronic hemodialysis (CKD-5HD).

Total participation in the study is approximately three weeks and is comprised of a screening visit, two dosing (PK) visits, and a follow-up visit.

Each patient will receive a single dose of Triferic administered IV into the venous blood return line over the duration of the dialysis. At the next scheduled dialysis session each patient will receive a single dose of Triferic administered via dialysate during a single hemodialysis session.

Blood samples will be obtained at various times to analyze for serum iron parameters and for safety.

Conditions: End Stage Renal Disease
Being tested: Triferic
Keywords: dialysis, pediatric, chronic kidney disease
Medical subject headings: Kidney Failure, Chronic, Renal Insufficiency, Chronic

What participants receive

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

TrifericDrug
Also called ferric pyrophosphate citrate, FPC

Study groups in NCT02595437
Study group	Role	What they receive
Triferic via IV and Hemodialysate	Experimental	On study Day 1, patients will receive IV Triferic iron 0.07 mg/kg diluted in an appropriate amount of D5W administered as a 100 mL infusion into the venous return port of the blood lines during the time the patient is receiving dialysis.The rate of administration will be calculated as such that the entire amount will be administered over the course of the dialysis treatment. On study Day 3, Triferic will be mixed with the liquid bicarbonate concentrate used in the preparation of the hemodialysate solution. This will result in a final Triferic iron concentration in the dialysate of 2 µM (110 µg/L). The patients will receive Triferic via the hemodialysate over the course of the dialysis treatment. Receives: Drug: Triferic

What is being measured

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

Pharmacokinetics (PK) of Triferic Iron Administered IV in Pediatric CKD-5HD Patients: Cmax.
The PK will be done by assessing the mean absolute and baseline-corrected Cmax of total iron with an IV infusion of Triferic at 0.07 mg iron/kg during a single dialysis session. The absolute Cmax includes the concentration of iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected Cmax factors out the iron present in the serum prior to dosing and includes the administered iron only.
Measured: 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hrs
Pharmacokinetics (PK) of Triferic Iron Administered IV in Pediatric CKD-5HD Patients: AUC(Last).
The PK will be done by assessing the mean absolute and baseline-corrected AUC(last) of total iron with an IV infusion of Triferic at 0.07 mg iron/kg during a single dialysis session. The absolute AUC(last) includes iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected AUC(last) factors out the iron present in the serum prior to dosing and includes the administered iron only.
Measured: 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours
Pharmacokinetics (PK) of Triferic Iron Administered IV in Pediatric CKD-5HD Patients: AUC(0-end).
The PK will be done by assessing the mean absolute and baseline-corrected AUC(0-end) of total iron with an IV infusion of Triferic at 0.07 mg iron/kg during a single dialysis session. The absolute AUC (0-end) includes iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected AUC (0-end) factors out the iron present in the serum prior to dosing and includes the administered iron only.
Measured: 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours

Secondary outcomes (3)

Pharmacokinetics (PK) of Triferic Iron Administered Via the Hemodialysate in Pediatric CKD-5HD Patients: Cmax.
The PK will be done by assessing the mean absolute and baseline-corrected Cmax of total iron. The absolute Cmax includes the concentration of iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected Cmax factors out the iron present in the serum prior to dosing and includes the administered iron only.
Measured: 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours
Pharmacokinetics (PK) of Triferic Iron Administered Via the Hemodialysate in Pediatric CKD-5HD Patients: AUC(Last).
The PK will be done by assessing the mean absolute and baseline-corrected AUC(last) of total iron. The absolute AUC (last) includes the iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected Cmax factors out the iron present in the serum prior to dosing and includes the administered iron only.
Measured: 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours
Pharmacokinetics (PK) of Triferic Iron Administered Via the Hemodialysate in Pediatric CKD-5HD Patients: AUC(0-end).
The PK will be done by assessing the mean absolute and baseline-corrected AUC(0-end) of total iron. The absolute AUC (0-end) includes the of iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected Cmax factors out the iron present in the serum prior to dosing and includes the administered iron only.
Measured: 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours

Timeline

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

1 Nov 2015Jan 2017

First posted3 Nov 2015 (estimated)
Study start1 Nov 2015
Primary completionDec 2016
Study completionJan 2017

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 End Stage Renal DiseaseStudies 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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02595437
Sponsor's protocol ID: RMFPC-11
Status last verified: Sep 2018
First submitted: 30 Oct 2015
Last updated: 25 Oct 2018
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?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics of Triferic (Ferric Pyrophosphate Citrate) Administered Via Dialysate and IV to Pediatric Patients on Chronic Hemodialysis
ClinicalTrials.gov ID: NCT02595437
Acronym / sponsor ID: RMFPC-11
Conditions: End Stage Renal Disease
Keywords: dialysis, pediatric, chronic kidney disease
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Rockwell Medical Technologies, Inc.Industry (pharma, biotech, devices)
Study start: 1 Nov 2015
Primary completion: Dec 2016 (actual)
Study completion: Jan 2017 (actual)
First posted: 3 Nov 2015 (estimated)
Results: Posted 25 Oct 2018

Clinical summary

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

Detailed description

Total participation in the study is approximately three weeks and is comprised of a screening visit, two dosing (PK) visits, and a follow-up visit.

Blood samples will be obtained at various times to analyze for serum iron parameters and for safety.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Triferic via IV and Hemodialysate	Experimental	Drug: TrifericOn study Day 1, patients will receive IV Triferic iron 0.07 mg/kg diluted in an appropriate amount of D5W administered as a 100 mL infusion into the venous return port of the blood lines during the time the patient is receiving dialysis.The rate of administration will be calculated as such that the entire amount will be administered over the course of the dialysis treatment. On study Day 3, Triferic will be mixed with the liquid bicarbonate concentrate used in the preparation of the hemodialysate solution. This will result in a final Triferic iron concentration in the dialysate of 2 µM (110 µg/L). The patients will receive Triferic via the hemodialysate over the course of the dialysis treatment.

Who may qualify

Ages: Up to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (13 listed)

A patient will be eligible for inclusion in the study only if all of the following criteria are met:
Parents/legal guardians of the patient have the ability to understand the requirements of the study and have demonstrated a willingness to have their child comply with all study procedures by signing an institutional review board-approved informed consent form. Where applicable, assent of the patient has also been obtained for all study procedures prior to any study-related activities.
Patient is <18 years of age at screening.
Patient has chronic kidney disease receiving in-center hemodialysis at least twice weekly for at least 1 month prior to screening.
Patient is receiving adequate hemodialysis as assessed by the investigator and based on a single pool Kt/V measurement >1.2.

Key exclusion criteria (7 listed)

A patient will not be eligible for inclusion in the study if any of the following criteria apply:
Patient is positive for human immunodeficiency virus (HIV) or hepatitis B by history.
Patient has an acute illness within 1 week of Baseline admission (patient may be screened again 2 weeks post resolution of the acute illness).
Patient is receiving intravenous or oral antibiotics or antifungals for any infectious process. Prophylactic antibiotics administered on a regular basis are allowed.
Patient has evidence of an ongoing active inflammatory process (e.g., systemic lupus erythematosus, acute or chronic active hepatitis, etc.).

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
TrifericAlso: ferric pyrophosphate citrate, FPC	Drug	Triferic via IV and Hemodialysate

Primary outcome

Pharmacokinetics (PK) of Triferic Iron Administered IV in Pediatric CKD-5HD Patients: Cmax.
Time frame: 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hrs
The PK will be done by assessing the mean absolute and baseline-corrected Cmax of total iron with an IV infusion of Triferic at 0.07 mg iron/kg during a single dialysis session. The absolute Cmax includes the concentration of iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected Cmax factors out the iron present in the serum prior to dosing and includes the administered iron only.
Pharmacokinetics (PK) of Triferic Iron Administered IV in Pediatric CKD-5HD Patients: AUC(Last).
Time frame: 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours
The PK will be done by assessing the mean absolute and baseline-corrected AUC(last) of total iron with an IV infusion of Triferic at 0.07 mg iron/kg during a single dialysis session. The absolute AUC(last) includes iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected AUC(last) factors out the iron present in the serum prior to dosing and includes the administered iron only.
Pharmacokinetics (PK) of Triferic Iron Administered IV in Pediatric CKD-5HD Patients: AUC(0-end).
Time frame: 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours
The PK will be done by assessing the mean absolute and baseline-corrected AUC(0-end) of total iron with an IV infusion of Triferic at 0.07 mg iron/kg during a single dialysis session. The absolute AUC (0-end) includes iron that was present in the serum prior to dosing as well the iron administered, while the baseline-corrected AUC (0-end) factors out the iron present in the serum prior to dosing and includes the administered iron only.

3 secondary outcomes

Pharmacokinetics (PK) of Triferic Iron Administered Via the Hemodialysate in Pediatric CKD-5HD Patients: Cmax.
Time frame: 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours
Pharmacokinetics (PK) of Triferic Iron Administered Via the Hemodialysate in Pediatric CKD-5HD Patients: AUC(Last).
Time frame: 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours
Pharmacokinetics (PK) of Triferic Iron Administered Via the Hemodialysate in Pediatric CKD-5HD Patients: AUC(0-end).
Time frame: 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours

Results and safety

Results posted to the registry on 25 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Triferic Via IV and Hemodialysate	22	21

Primary outcome: Pharmacokinetics (PK) of Triferic Iron Administered IV in Pediatric CKD-5HD Patients: Cmax.

Time frame: 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hrs. Geometric mean (Geometric Coefficient of Variation). Unit: microgram/deciliter

Measure	Triferic 0.07 mg/kg Iron Intravenous: Absolute Value n = 21	Triferic 0.07 mg/kg Iron Intravenous: Baseline Corrected n = 21
Value	217 (28.0)	114 (53.7)

Population analysed: Pharmacokinetic Group: all patients who received at least one dose of study drug and have sufficient PK samples (a sample at the end of infusion and at least 3 samples during the elimination phase)

Primary outcome: Pharmacokinetics (PK) of Triferic Iron Administered IV in Pediatric CKD-5HD Patients: AUC(Last).

Time frame: 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours. Geometric mean (Geometric Coefficient of Variation). Unit: hours* micrograms/ deciliters

Measure	Triferic 0.07 mg/kg Iron Intravenous: Absolute Value n = 21	Triferic 0.07 mg/kg Iron Intravenous: Baseline Corrected n = 21
Value	1324 (36.5)	419 (101.6)

Primary outcome: Pharmacokinetics (PK) of Triferic Iron Administered IV in Pediatric CKD-5HD Patients: AUC(0-end).

Time frame: 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hours. Geometric mean (Geometric Coefficient of Variation). Unit: hours* micrograms/ deciliters

Measure	Triferic 0.07 mg/kg Iron Intravenous: Absolute Value n = 21	Triferic 0.07 mg/kg Iron Intravenous: Baseline Corrected n = 21
Value	648 (29.3)	237 (76.8)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1.5 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IV Exposure	0 of 22 (0%)	4 of 22 (18.2%)	0 of 22
IV and Hemodialysate Exposure	0 of 21 (0%)	3 of 21 (14.3%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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

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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Triferic in people with End Stage Renal Disease, run by Rockwell Medical Technologies, Inc. at 9 sites 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 13 inclusion and 7 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 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 25 Oct 2018). 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 (PK) of Triferic Iron Administered IV in Pediatric CKD-5HD Patients: Cmax. (time frame: 0, 1, 2, 4, 4.5, 5, 6, 8, 10 hrs). The study lists 3 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 NCT02595437.

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 25 Oct 2018.