End Stage Renal DiseasePhase 1/2NCT04409132
Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus.
A Phase 1/2 study testing Triferic in people with End Stage Renal Disease, run by Rockwell Medical Technologies, Inc. at 1 site in United States.
Trial summary
This study will investigate the administration of Triferic AVNU intravenously by three different administration schedules compared to continuous infusion over 3 hours 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2020to 2 Apr 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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.
- Able to sustain hemodialysis 3x/week for 3 to 4 hours.
- Hemoglobin concentration >9.5 g/dL.
- Serum TSAT ≥20%.
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- Receiving hemodialysis via AV fistula or graft.
- Able to receive hemodialysis for 4 hours at each session over the duration of the treatment periods.
- Able to receive intermittent heparin administration for anticoagulation of the dialysis circuit.
- Serum TIBC ≥ 150 µg/dL.
Who cannot join
- Active bleeding disorder (GI, skin, nasal…)
- Receiving hemodialysis via catheter.
- Receiving IV iron within 10 days of the first on-study hemodialysis treatment.
- Receiving oral iron within 10 days of the first on-study hemodialysis treatment.
- Any other condition, that in the opinion of the investigator would not allow completion of the 4 hemodialysis treatments in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: A Randomized 4 Period Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus.
This study will investigate the administration of Triferic AVNU intravenously by three different administration schedules compared to continuous infusion over 3 hours
Read the detailed description
An open-label, randomized, four period sequential study of Triferic AVNU administered intravenously by three different administration schedules compared to continuous infusion over 3 hours
- Conditions
- End Stage Renal Disease
- Being tested
- Triferic
- Keywords
- Pharmacokinetics
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Triferic AVNU infusion pre-dialyzer | Experimental | Patients will receive one (1) 6.75 mg Fe dose of Triferic AVNU by continuous infusion over 3 hours into the predialyzer blood line. Receives: Drug: Triferic |
| Triferic AVNU for injection at T=0 and T= 3 hours | Experimental | Patients will receive two (2) doses of Triferic AVNU 3.4 mg IV (2.25 mL) at T=0 and T=3 hours of hemodialysis into the venous drip chamber. Receives: Drug: Triferic |
| Triferic AVNU for injection at T=0 | Experimental | Patients will receive one (1) dose of Triferic AVNU 0.08 mg/kg IV, up to 6.75 mg Fe, at T=0 of hemodialysis into the venous drip chamber. Receives: Drug: Triferic |
| Triferic AVNU for injection at T=0, T=1.5 and T= 3 hours | Experimental | Patients will receive three (3) doses of Triferic AVNU 2.25 mg Fe (1.5 mL) at T=0, T=1.5 and T=3.0 hours of hemodialysis into the venous drip chamber. Receives: Drug: Triferic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under plasma concentration-time curve (AUC0-last pFetotal) for all Treatments A,B,C and D
Measured: 8 hours
Area under plasma transferrin bound plasma iron concentration- time curve (AUC0-last FeTBI) for all Treatments A,B,C and D
Measured: 8 hours
Secondary outcomes (4)
Maximum observed plasma iron concentration (Cmax pFetotal) for all Treatments A,B,C and D
Measured: 8 hours
Maximum observed transferrin bound plasma iron concentration (Cmax FeTBI) for all Treatments A,B,C and D
Measured: 8 hours
Maximum observed serum iron concentration (Cmax sFetotal) for all Treatments A,B,C and D
Measured: 8 hours
Area under serum Fe concentration-time curve (AUC0-last sFetotal) for all Treatments A,B,C and D
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start25 Jun 2020
- Primary completion2 Apr 2021
- Study completion2 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockwell Medical Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raymond D Pratt, MD, FACP, Study director, Rockwell Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409132
- Sponsor's protocol ID
- RMFPC-26
- Status last verified
- Apr 2021
- First submitted
- 26 May 2020
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized 4 Period Study to Investigate the Pharmacokinetic Comparability of Dosing Triferic AVNU IV by Continuous Infusion and IV Bolus.
- ClinicalTrials.gov ID
- NCT04409132
- Acronym / sponsor ID
- RMFPC-26
- Conditions
- End Stage Renal Disease
- Keywords
- Pharmacokinetics
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Rockwell Medical Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- 2 Apr 2021 (actual)
- Study completion
- 2 Apr 2021 (actual)
- First posted
- 1 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the administration of Triferic AVNU intravenously by three different administration schedules compared to continuous infusion over 3 hours
Detailed description
An open-label, randomized, four period sequential study of Triferic AVNU administered intravenously by three different administration schedules compared to continuous infusion over 3 hours
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Triferic AVNU infusion pre-dialyzer | Experimental | Drug: TrifericPatients will receive one (1) 6.75 mg Fe dose of Triferic AVNU by continuous infusion over 3 hours into the predialyzer blood line. |
| Triferic AVNU for injection at T=0 and T= 3 hours | Experimental | Drug: TrifericPatients will receive two (2) doses of Triferic AVNU 3.4 mg IV (2.25 mL) at T=0 and T=3 hours of hemodialysis into the venous drip chamber. |
| Triferic AVNU for injection at T=0 | Experimental | Drug: TrifericPatients will receive one (1) dose of Triferic AVNU 0.08 mg/kg IV, up to 6.75 mg Fe, at T=0 of hemodialysis into the venous drip chamber. |
| Triferic AVNU for injection at T=0, T=1.5 and T= 3 hours | Experimental | Drug: TrifericPatients will receive three (3) doses of Triferic AVNU 2.25 mg Fe (1.5 mL) at T=0, T=1.5 and T=3.0 hours of hemodialysis into the venous drip chamber. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adult hemodialysis patients ≥18 years of age.
- Signed informed consent to participate in the study.
- Stable on hemodialysis prescription for ≥3 months.
- Able to sustain hemodialysis 3x/week for 3 to 4 hours.
- Hemoglobin concentration >9.5 g/dL.
Key exclusion criteria (5 listed)
- Active bleeding disorder (GI, skin, nasal…)
- Receiving hemodialysis via catheter.
- Receiving IV iron within 10 days of the first on-study hemodialysis treatment.
- Receiving oral iron within 10 days of the first on-study hemodialysis treatment.
- Any other condition, that in the opinion of the investigator would not allow completion of the 4 hemodialysis treatments in the study.
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 AVNU for injection at T=0, Triferic AVNU for injection at T=0 and T= 3 hours, Triferic AVNU for injection at T=0, T=1.5 and T= 3 hours, Triferic AVNU infusion pre-dialyzer |
Primary outcome
Area under plasma concentration-time curve (AUC0-last pFetotal) for all Treatments A,B,C and D
Time frame: 8 hours
Area under plasma transferrin bound plasma iron concentration- time curve (AUC0-last FeTBI) for all Treatments A,B,C and D
Time frame: 8 hours
4 secondary outcomes
Maximum observed plasma iron concentration (Cmax pFetotal) for all Treatments A,B,C and D
Time frame: 8 hours
Maximum observed transferrin bound plasma iron concentration (Cmax FeTBI) for all Treatments A,B,C and D
Time frame: 8 hours
Maximum observed serum iron concentration (Cmax sFetotal) for all Treatments A,B,C and D
Time frame: 8 hours
Area under serum Fe concentration-time curve (AUC0-last sFetotal) for all Treatments A,B,C and D
Time frame: 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Individual participant dataSharing planned: No
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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
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 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 10 inclusion and 5 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 13 Jul 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Area under plasma concentration-time curve (AUC0-last pFetotal) for all Treatments A,B,C and D (time frame: 8 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?
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 13 Jul 2021.