End Stage Renal DiseasePhase 1/2NCT04042324

A Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients

A Phase 1/2 study testing Triferic and Heparin 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

This study will investigate the effect of co-administration of Triferic and heparin on the ability to maintain circuit anti-coagulation and iron delivery when compared to control conditions when each treatment is administered via separate routes. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: End Stage Renal Disease
What is being tested?: Triferic and Heparin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 30 Sep 2019to 16 Jan 2020
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult hemodialysis patients ≥18 years of age.
Signed informed consent to participate in the study.
Stable on hemodialysis prescription for ≥3 months.
Hemoglobin concentration >9.5 g/dL.
Serum TSAT ≥20%.
Able to receive continuous heparin infusion as their anticoagulation protocol.
Receiving hemodialysis via AV (arteriovenous) fistula or graft.
Able to receive hemodialysis for 4 hours at each session over the duration of the treatment periods.

Who cannot join

Active bleeding disorder (GI, skin, nasal…)
Receiving hemodialysis via catheter.
Receiving heparin free dialysis.
Receiving low molecular weight heparin as sole anti-coagulation for dialysis.
Receiving IV iron within 2 weeks of the first on-study hemodialysis treatment.
Receiving oral anti-coagulants or anti-platelet agents.
Any other condition, that in the opinion of the investigator would not allow completion of the 3 hemodialysis treatments in 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

Official title: A Randomized 3 Period Crossover Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients

Conditions: End Stage Renal Disease
Being tested: Triferic, Heparin
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
Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.
HeparinDrug
Also called Unfractionated heparin, UFH
Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.

Study groups in NCT04042324
Study group	Role	What they receive
Triferic post-dialyzer; UFH via continuous infusion	Experimental	Patients will receive Triferic 6.75 mg IV over 3 hours into the post-dialyzer blood line (or drip chamber) administered by an infusion pump. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin using the on-machine infusion pump. The infusion of heparin to be stopped at hour 3 of hemodialysis. Receives: Drug: Triferic; Drug: Heparin
UFH and Triferic admixture	Experimental	Patients will receive Triferic 6.75 mg IV plus the appropriate volume of unfractionated heparin for continuous infusion over 3 hours into the pre-dialyzer "heparin line". This mixture will be administered by the on-machine syringe infusion pump for continuous infusion. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of Triferic + heparin. The infusion of Triferic + heparin will be stopped at hour 3 of hemodialysis. Receives: Drug: Triferic; Drug: Heparin
UFH via continuous infusion pre-dialyzer	Experimental	Patients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis Receives: Drug: Heparin

What is being measured

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

Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-t
Measured: 8 hours

Secondary outcomes (5)

Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-4 Hours
Measured: 4 hours
aPTT (Activated Partial Thromboplastin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours
Measured: 4 hours
TT (Thrombin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours
Measured: 4 hours
Iron Profile as Measured by the sFe Cmax (Peak Serum Iron Concentration)
Measured: 8 hours
Iron Profile as Measured by the AUC (Area Under the Curve) 0-t
Measured: 8 hours

Timeline

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

30 Sep 201916 Jan 2020

First posted1 Aug 2019
Study start30 Sep 2019
Primary completion16 Jan 2020
Study completion16 Jan 2020

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: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04042324
Sponsor's protocol ID: RMFPC-24
Status last verified: Nov 2020
First submitted: 22 Jul 2019
Last updated: 2 Dec 2020
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 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized 3 Period Crossover Study to Investigate the Effect of Triferic Plus Heparin Infusion Compared to Heparin Alone on Coagulation Parameters in Hemodialysis Patients
ClinicalTrials.gov ID: NCT04042324
Acronym / sponsor ID: RMFPC-24
Conditions: End Stage Renal Disease
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Rockwell Medical Technologies, Inc.Industry (pharma, biotech, devices)
Study start: 30 Sep 2019 (actual)
Primary completion: 16 Jan 2020 (actual)
Study completion: 16 Jan 2020 (actual)
First posted: 1 Aug 2019 (actual)
Results: Posted 12 Nov 2020

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 post-dialyzer; UFH via continuous infusion	Experimental	Drug: Triferic, Drug: HeparinPatients will receive Triferic 6.75 mg IV over 3 hours into the post-dialyzer blood line (or drip chamber) administered by an infusion pump. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin using the on-machine infusion pump. The infusion of heparin to be stopped at hour 3 of hemodialysis.
UFH and Triferic admixture	Experimental	Drug: Triferic, Drug: HeparinPatients will receive Triferic 6.75 mg IV plus the appropriate volume of unfractionated heparin for continuous infusion over 3 hours into the pre-dialyzer "heparin line". This mixture will be administered by the on-machine syringe infusion pump for continuous infusion. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of Triferic + heparin. The infusion of Triferic + heparin will be stopped at hour 3 of hemodialysis.
UFH via continuous infusion pre-dialyzer	Experimental	Drug: HeparinPatients will receive no Triferic. Anti-coagulation will be provided by a bolus of heparin administered into the venous return line immediately prior to the initiation of hemodialysis followed by a continuous infusion of heparin via the on-machine syringe pump. The infusion of heparin to be stopped at hour 3 of hemodialysis

Who may qualify

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

Key inclusion criteria (8 listed)

Adult hemodialysis patients ≥18 years of age.
Signed informed consent to participate in the study.
Stable on hemodialysis prescription for ≥3 months.
Hemoglobin concentration >9.5 g/dL.
Serum TSAT ≥20%.

Key exclusion criteria (7 listed)

Active bleeding disorder (GI, skin, nasal…)
Receiving hemodialysis via catheter.
Receiving heparin free dialysis.
Receiving low molecular weight heparin as sole anti-coagulation for dialysis.
Receiving IV iron within 2 weeks of the first on-study hemodialysis treatment.

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, FPCTriferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.	Drug	Triferic post-dialyzer; UFH via continuous infusion, UFH and Triferic admixture
HeparinAlso: Unfractionated heparin, UFHUnfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.	Drug	Triferic post-dialyzer; UFH via continuous infusion, UFH and Triferic admixture, UFH via continuous infusion pre-dialyzer

Primary outcome

Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-t
Time frame: 8 hours

5 secondary outcomes

Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-4 Hours
Time frame: 4 hours
aPTT (Activated Partial Thromboplastin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours
Time frame: 4 hours
TT (Thrombin Time) as Measured by the AUC (Area Under the Curve) 0-4 Hours
Time frame: 4 hours
Iron Profile as Measured by the sFe Cmax (Peak Serum Iron Concentration)
Time frame: 8 hours
Iron Profile as Measured by the AUC (Area Under the Curve) 0-t
Time frame: 8 hours

Results and safety

Results posted to the registry on 12 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
UFH and Triferic Admixture (Day 1)	12	12
Triferic Post-dialyzer; UFH Via Continuous Infusion (Day 3)	0	0
UFH Via Continuous Infusion Pre-dialyzer (Day 5)	0	0

Primary outcome: Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-t

Time frame: 8 hours. Geometric mean (Geometric Coefficient of Variation). Unit: IU*hr/mL

Measure	UFH and Triferic Admixture n = 12	UFH Via Continuous Infusion Pre-dialyzer n = 12
Value	.798 (61.6)	.733 (62.4)

5 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
Triferic Post-dialyzer; UFH Via Continuous Infusion	0 of 12 (0%)	0 of 12 (0%)	0 of 12
UFH and Triferic Admixture	0 of 12 (0%)	0 of 12 (0%)	0 of 12
UFH Via Continuous Infusion Pre-dialyzer	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
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.

Raymond Pratt, MD study director

Rockwell Medical

1 site 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 and Heparin 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 8 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 2 Dec 2020. 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 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 12 Nov 2020). 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?

Anti-Xa Activity as Measured by the AUC (Area Under the Curve) 0-t (time frame: 8 hours). 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 NCT04042324.

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 2 Dec 2020.