End Stage Renal DiseasePhase 1NCT02739100

Pharmacokinetics and Preliminary Bioequivalence of Triferic (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients

A Phase 1 study testing Triferic in people with End Stage Renal Disease, 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

Search all trials

Trial summary

The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered via hemodialysate and via two different intravenous routes in adult patients with chronic kidney disease on chronic hemodialysis (CKD-5HD). It is an open-label, randomized single dose study. Read more about this study

Who is it for?: Ages 18 to 65 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: 13 participants
Where: 1 siteUnited States
Study dates: Apr 2016to Jul 2016
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The patient must be able to provide informed consent and have personally signed and dated the written informed consent document before completing any study-related procedures.
The patient must have been undergoing chronic hemodialysis for chronic kidney disease for at least 3 months, and is expected to remain on hemodialysis and be able to complete the study.
The patient must have a Screening ferritin level of ≥100μg/L.
The patient must have a Screening transferrin saturation (TSAT) of 15-45%, inclusive.
The patient must have a Screening total iron binding capacity (TIBC) ≥175 μg/dL.
The patient must have a Screening hemoglobin (Hgb) concentration ≥9.5 g/dL.

Show all 12Show fewer

The patient must be undergoing hemodialysis at least 3x/week.
The patient must have at least a minimally adequate measured dialysis dose defined as single-pool Kt/V (dialyzer clearance of urea multiplied by dialysis time, divided by patient's total body water) ≥1.2, or KIDt/V (online dialyzer clearance measured using ionic dialysance multiplied by dialysis time, divided by patient's total body water) ≥1.2 measured within the 28 days prior to Baseline.
Patient is receiving, or can receive anticoagulation for dialysis by a single dose of unfractionated heparin or low molecular weight heparin pre-dialysis; or by intermittent IV heparin bolus.
The patient's vascular access for dialysis that will be used during the study must have stable function in the judgment of the Investigator.
The patient must agree to discontinue all iron preparations (oral and IV) for 14 days prior to Baseline.
Female patients must not be pregnant or breastfeeding. They must have been amenorrheic for the past year or be surgically sterile or agree to not become pregnant by continuous use of an effective birth control method acceptable to the Investigator for the duration of their participation in the study.

Who cannot join

The patient has had an RBC or whole blood transfusion within 4 weeks prior to Screening.
The patient requires a continuous infusion of heparin during standard hemodialysis.
The patient has had administration of IV or oral iron supplements (including multivitamins with iron) within 14 days prior to Baseline.
The patient has known active bleeding from any site other than AV fistula or graft (e.g., gastrointestinal, hemorrhoidal, nasal, pulmonary, etc.).
The patient has a living kidney donor identified or living-donor kidney transplant scheduled to occur during study participation. (Note: Patients awaiting deceased-donor transplant need not be excluded.)
The patient's vascular access for hemodialysis is a femoral catheter.

Show all 19Show fewer

The patient is scheduled to have a surgical procedure during the study.
The patient has had a hospitalization within the 4 weeks prior to Screening (except for vascular access surgery) that, in the opinion of the Investigator, confers a significant risk of hospitalization during the course of the study.
The patient has a history of noncompliance with the dialysis regimen in the opinion of the Investigator
The patient has a known ongoing inflammatory disorder (other than CKD), such as systemic lupus erythematosus, rheumatoid arthritis, or other collagen-vascular disease, that currently requires systemic anti-inflammatory or immunomodulatory therapy.
The patient has any current febrile illness (e.g., oral temperature ≥100.4°F, 38.0°C). (The patient may subsequently become eligible at least 1 week after resolution of the illness.)
The patient has known bacterial, tuberculosis, fungal, viral, or parasitic infection requiring anti-microbial therapy or anticipated to require anti-microbial therapy during the patient's participation in this study.
The patient is known to be positive for HIV, hepatitis B, or hepatitis C (viral testing is not required as part of this protocol).
The patient has cirrhosis of the liver based on histological criteria or clinical criteria (e.g., presence of ascites, esophageal varices, multiple spider nevi, or history of hepatic encephalopathy).
The patient has ALT and/or AST levels consistently greater than twice the upper limit of normal at any time during the two months prior to Baseline.
The patient currently has any malignancy other than basal or squamous cell skin cancer.
The patient has a history of drug or alcohol abuse within the 6 months prior to Screening.
The patient participated in an investigational drug study within 30 days prior to Baseline.
The patient has any condition that, in the opinion of the Investigator, would make it unlikely for the patient to complete the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Orlando Clinical Research Center
Orlando, Florida, 32809

Other trials in United States

About this study

Conditions: End Stage Renal Disease
Being tested: Triferic
Keywords: pharmacokinetics, bioequivalence
Medical subject headings: Kidney Failure, 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 NCT02739100
Study group	Role	What they receive
Triferic via Hemodialysate	Experimental	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. Intervention Drug: Triferic Receives: Drug: Triferic
Triferic via IV infusion	Experimental	Patients will receive a single 6.6-mg dose of Triferic iron administered IV over 4 hrs during hemodialysis via the unused heparin infusion line (pre-dialyzer). Intervention: Drug: Triferic Receives: Drug: Triferic
Triferic IV infusion	Experimental	Patients will receive a single 6.6-mg dose of Triferic iron administered IV over 4 hrs during hemodialysis via an infusion port (post-dialyzer). Intervention: Drug: Triferic 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 Via Hemodialysate in Adult CKD-5HD Patients: Cmax.
The PK will be done by assessing the mean Cmax of total serum iron from Triferic administered via hemodialysate, compared to Triferic administered at a fixed IV dose of 6.6 mg iron/kg during a single dialysis session.
Measured: 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours
Pharmacokinetics (PK) of Triferic Iron Administered IV in Adult CKD-5HD Patients: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantified Concentration (AUC(Last)).
The PK will be done by assessing the mean area under the serum concentration-time curve from time zero to the time of the last quantified concentration (AUC(last)) and comparing between Triferic administered via hemodialysate and Triferic administered at a fixed IV dose of 6.6 mg iron/kg (pre-dialyzer and post-dialyzer) during a single dialysis session.
Measured: 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours

Secondary outcomes (2)

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Safety will be documented by recording the incidence of treatment-emergent adverse events (TEAEs)
Measured: 13 days
Number of Participants With Treatment-emergent Serious Adverse Events (TEAEs)
Safety will be documented by recording the incidence of treatment-emergent serious adverse events (TESAEs)
Measured: 13 days

Timeline

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

Apr 2016Jul 2016

First posted14 Apr 2016 (estimated)
Study startApr 2016
Primary completionJul 2016
Study completionJul 2016

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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02739100
Sponsor's protocol ID: RMFPC-16
Status last verified: Aug 2018
First submitted: 11 Apr 2016
Last updated: 1 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: 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

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult

All End Stage Renal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics and Preliminary Bioequivalence of Triferic (Ferric Pyrophosphate Citrate) Administered Via Hemodialysate and Intravenously to Adult CKD-5HD Patients
ClinicalTrials.gov ID: NCT02739100
Acronym / sponsor ID: RMFPC-16
Conditions: End Stage Renal Disease
Keywords: pharmacokinetics, bioequivalence
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: Rockwell Medical Technologies, Inc.Industry (pharma, biotech, devices)
Study start: Apr 2016
Primary completion: Jul 2016 (actual)
Study completion: Jul 2016 (actual)
First posted: 14 Apr 2016 (estimated)
Results: Posted 1 Feb 2019

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Triferic via Hemodialysate	Experimental	Drug: TrifericTriferic 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. Intervention Drug: Triferic
Triferic via IV infusion	Experimental	Drug: TrifericPatients will receive a single 6.6-mg dose of Triferic iron administered IV over 4 hrs during hemodialysis via the unused heparin infusion line (pre-dialyzer). Intervention: Drug: Triferic
Triferic IV infusion	Experimental	Drug: TrifericPatients will receive a single 6.6-mg dose of Triferic iron administered IV over 4 hrs during hemodialysis via an infusion port (post-dialyzer). Intervention: Drug: Triferic

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

The patient must be able to provide informed consent and have personally signed and dated the written informed consent document before completing any study-related procedures.
The patient must have been undergoing chronic hemodialysis for chronic kidney disease for at least 3 months, and is expected to remain on hemodialysis and be able to complete the study.
The patient must have a Screening ferritin level of ≥100μg/L.
The patient must have a Screening transferrin saturation (TSAT) of 15-45%, inclusive.
The patient must have a Screening total iron binding capacity (TIBC) ≥175 μg/dL.

Key exclusion criteria (19 listed)

The patient has had an RBC or whole blood transfusion within 4 weeks prior to Screening.
The patient requires a continuous infusion of heparin during standard hemodialysis.
The patient has had administration of IV or oral iron supplements (including multivitamins with iron) within 14 days prior to Baseline.
The patient has known active bleeding from any site other than AV fistula or graft (e.g., gastrointestinal, hemorrhoidal, nasal, pulmonary, etc.).
The patient has a living kidney donor identified or living-donor kidney transplant scheduled to occur during study participation. (Note: Patients awaiting deceased-donor transplant need not be excluded.)

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 IV infusion, Triferic via Hemodialysate, Triferic via IV infusion

Primary outcome

Pharmacokinetics (PK) of Triferic Iron Administered Via Hemodialysate in Adult CKD-5HD Patients: Cmax.
Time frame: 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours
The PK will be done by assessing the mean Cmax of total serum iron from Triferic administered via hemodialysate, compared to Triferic administered at a fixed IV dose of 6.6 mg iron/kg during a single dialysis session.
Pharmacokinetics (PK) of Triferic Iron Administered IV in Adult CKD-5HD Patients: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantified Concentration (AUC(Last)).
Time frame: 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours
The PK will be done by assessing the mean area under the serum concentration-time curve from time zero to the time of the last quantified concentration (AUC(last)) and comparing between Triferic administered via hemodialysate and Triferic administered at a fixed IV dose of 6.6 mg iron/kg (pre-dialyzer and post-dialyzer) during a single dialysis session.

2 secondary outcomes

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: 13 days
Number of Participants With Treatment-emergent Serious Adverse Events (TEAEs)
Time frame: 13 days

Results and safety

Results posted to the registry on 1 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	13	13

Primary outcome: Pharmacokinetics (PK) of Triferic Iron Administered Via Hemodialysate in Adult CKD-5HD Patients: Cmax.

Time frame: 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours. Mean (Standard Deviation). Unit: microgram per deciliter

Measure	Triferic Via Hemodialysate n = 13	Triferic Via IV Infusion Pre-dialyzer n = 13	Triferic IV Infusion Post-dialyzer n = 13
Value	124 (49.9)	131 (30.5)	124 (42.4)

Primary outcome: Pharmacokinetics (PK) of Triferic Iron Administered IV in Adult CKD-5HD Patients: Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantified Concentration (AUC(Last)).

Time frame: 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours. Mean (Standard Deviation). Unit: hours*microgram/deciliter

Measure	Triferic Via Hemodialysate n = 12	Triferic Via IV Infusion Pre-dialyzer n = 10	Triferic IV Infusion Post-dialyzer n = 13
Value	621 (355)	630 (275)	524 (272)

Population analysed: While all subjects were included in PK analysis, some PK samples were below the lower limit of quantitation (BLQ) of the bioanalytical lab assay. Therefore, the number of subjects analyzed differs from the overall total number of study participants.

2 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
Triferic Via Hemodialysate	0 of 13 (0%)	1 of 13 (7.7%)	0 of 13
Triferic Via IV Infusion Pre-dialyzer	0 of 13 (0%)	2 of 13 (15.4%)	0 of 13
Triferic IV Infusion Post-dialyzer	0 of 13 (0%)	0 of 13 (0%)	0 of 13

Limitations and caveats (from the sponsor): The bioanalytical (ICP MS) assay used for the primary PK analysis was extremely sensitive to hemolyzed samples. The clinical laboratory assay was a better method of quantification for this study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for End Stage Renal Disease

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult

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.

The record lists no contact. Use the official record to reach the sponsor.

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 Triferic in people with End Stage Renal Disease, 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 12 inclusion and 19 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 1 Feb 2019. 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. 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 1 Feb 2019). 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 Via Hemodialysate in Adult CKD-5HD Patients: Cmax. (time frame: 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours). The study lists 2 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 NCT02739100.

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 1 Feb 2019.