End Stage Renal DiseasePhase 3NCT04239391
Hemoglobin Maintenance in Pediatric ESRD (End-stage Renal Disease) Patients by Ferric Pyrophosphate Citrate (FPC)
A Phase 3 study testing Triferic in people with End Stage Renal Disease, run by Rockwell Medical Technologies, Inc. at 9 sites in 2 countries.
Trial summary
The main purpose is to determine the safety of Triferic iron administered via dialysate and intravenously in pediatric patients with chronic kidney disease on chronic hemodialysis (CKD-5HD). It is a global, multi- center, open-label study. Read more about this study
- Who is it for?
- Ages 6 months 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
- 150 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 1 Sep 2020to 1 Nov 2023
- Phase
- Phase 3
- 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 6 months 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 between 6 months and <18 years of age at screening.
- Patient has chronic kidney disease receiving in-center hemodialysis at least twice weekly for at least 3 months 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.
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- Patient has a body mass of ≥11 lbs (5 kg).
- Patient is iron-replete as measured by a TSAT ≥ 20% and a ferritin >100 µg/L at screening.
- Patient has a whole blood Hgb concentration of ≥ 9.5 g/dL at screening.
- 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 who have reached menarche 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.
- Patients who have experienced a previous adverse event with IV iron products are eligible to participate in this study if the agent that caused the event is not administered during the Baseline period.
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 is receiving intravenous or oral antibiotics or antifungals for any infectious process. (Prophylactic antibiotics administered on a regular basis are allowed. Patients may enter the study once the infection has cleared.)
- Patient has evidence of an ongoing active inflammatory process (e.g., systemic lupus erythematosus, acute or chronic active hepatitis, etc.) requiring treatment.
- Patient has been dosed in an investigational drug study within the 30 days prior to Baseline.
- Administration of iron containing phosphate binder ferric citrate (Auryxia) or sucroferric oxyhydroxide (Velphoro) within 2 weeks prior to Baseline. (Patient is only eligible if iron based binders are stopped at least 2 weeks prior to Baseline).
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States8 sites, 8 recruiting
- Recruiting
Carolina's Medical Center
Charlotte, North Carolina, 28203
Jennifer Lamothe, 704-446-3705, jennifer.lamothe@atriumhealth.org
Donald Weaver, MD
- Recruiting
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Bliss Magella, 513-636-7832, Bliss.Magella@cchmc.org
Francisco Flores, MD
- Recruiting
Riley Hospital for Children at Indiana University
Indianapolis, Indiana, 46202
Sherry Wilson, slw2@iu.edu
Neha Pottanat, MD
- Recruiting
Children's Mercy Hospital
Kansas City, Missouri, 64108
Stephen Morrison, ssmorison@cmh.edu
Bradley Warady, MD
- Recruiting
Loma Linda University Hospital
Loma Linda, California, 92354
Jacqueline Lopez, JANLopez@llu.edu
Rita Sheth, MD
- Recruiting
University of Texas Health Science Center At San Antonio
San Antonio, Texas, 78229
Sonia Januario, januario@uthscsa.edu
Mazen Arar, MD
- Recruiting
Childrens Hospital and Medical Center- Seattle
Seattle, Washington, 98105
Megan Kelton, 206-987-5539, Megan.Kelton@seattlechildrens.org
Jodi Smith, MD
- Recruiting
Childrens Hospital National Medical Center
Washington D.C., District of Columbia, 20010
Nadia Itani, njitani@childrensnational.org
Marva Moxey Mims, MD
Puerto Rico1 site, 1 recruiting
- Recruiting
University of Puerto Rico School of Medicine
San Juan, 00963-5067
Marta Suarez, MD, 787-759-9595, marta.suarez@upr.edu
About this study
Official title: Hemoglobin Maintenance in Pediatric ESRD Patients by Ferric Pyrophosphate Citrate (FPC)
The main purpose is to determine the safety of Triferic iron administered via dialysate and intravenously in pediatric patients with chronic kidney disease on chronic hemodialysis (CKD-5HD). It is a global, multi- center, open-label study.
Read the detailed description
This is a global, multi- center, multi dose, open-label study assessing the safety of Triferic iron administered via dialysate and intravenously to pediatric patients (< 18 years of age) receiving chronic hemodialysis (CKD-5HD).
Total participation in the study is approximately 44 weeks and is comprised of a screening visit, baseline, open label treatment, and a follow-up visit.
Upon completion of the respective Baseline observational periods, all patients will transition to the interventional period where they will receive Triferic. The Triferic will be administered via the liquid bicarbonate or via IV. Once patients enter the interventional period, IV iron will only be administered if ferritin <100 µg/L and Hgb decreases by ≥0.5g/dL from the last value obtained in the observational Baseline period. Patients will remain in the interventional period for either 36 or 28 weeks (depending on randomization assignment), at which time a final study visit will take place.
- Conditions
- End Stage Renal Disease
- Being tested
- Triferic
- Keywords
- dialysis, pediatric, chronic kidney disease, anemia
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrifericDrug
Also called FPC
Ferric Pyrophosphate Citrate
| Study group | Role | What they receive |
|---|---|---|
| Triferic via IV and Hemodialysate | Experimental | Upon completion of the Baseline observational periods, all enrolled patients will transition to the interventional period where they will then receive Triferic. The Triferic will be administered via the liquid bicarbonate concentrate at a dialysate concentration of 2 uM or via IV at a dose of 0.1 mg Fe/kg, if the patient does not receive dialysis using liquid bicarbonate, for up to an additional 36 weeks (depending on duration of observational Baseline period). Hgb and CHr will continue to be measured bi-weekly and iron profiles will be obtained at 4 week intervals. In the Triferic phase of the study,changes in ESA dose will be allowed according to the study site existing protocol. IV iron will only be administered if ferritin meets the criteria for iron deficiency. Patients will remain in the interventional period for either 36 or 28 weeks (depending on randomization assignment), at which time a final study visit will take place Receives: Drug: Triferic |
| Historic Control Observational Arm | No intervention | Up to 75 patients will be enrolled in the Observational Arm. Patients who participate in the historical control observational arm will not receive any study medication, but will have Hgb, CHr and serum iron profiles collected at 4 week intervals for up to a total of 44 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the incidence of adverse events of Triferic administration via dialysate and IV in pediatric CKD-5HD patients
Incidence and severity of adverse events compared to Baseline.
Measured: 44 weeks
Secondary outcomes (3)
Assess the ability of Triferic to maintain hemoglobin in pediatric CKD-5HD patients
Change from Baseline in hemoglobin concentration
Measured: 44 weeks
Assess the proportion of patients maintaining hemoglobin between 10.5-12.0 g/dL compared to baseline
Proportion of patients maintaining hemoglobin between 10.5 - 12.0 g/dL compared toBaseline
Measured: 44 weeks
Assess the change in reticulocyte hemoglobin content (CHr).
Change from Baseline in reticulocyte hemoglobin content (CHr).
Measured: 44 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Sep 2020
- Primary completion31 Aug 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
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, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239391
- Sponsor's protocol ID
- RMFPC-22
- Status last verified
- Feb 2021
- First submitted
- 20 Jan 2020
- Last updated
- 21 Apr 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 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemoglobin Maintenance in Pediatric ESRD Patients by Ferric Pyrophosphate Citrate (FPC)
- ClinicalTrials.gov ID
- NCT04239391
- Acronym / sponsor ID
- RMFPC-22
- Conditions
- End Stage Renal Disease
- Keywords
- dialysis, pediatric, chronic kidney disease, anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Rockwell Medical Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 27 Jan 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.
The main purpose is to determine the safety of Triferic iron administered via dialysate and intravenously in pediatric patients with chronic kidney disease on chronic hemodialysis (CKD-5HD). It is a global, multi- center, open-label study.
Detailed description
This is a global, multi- center, multi dose, open-label study assessing the safety of Triferic iron administered via dialysate and intravenously to pediatric patients (< 18 years of age) receiving chronic hemodialysis (CKD-5HD).
Total participation in the study is approximately 44 weeks and is comprised of a screening visit, baseline, open label treatment, and a follow-up visit.
Upon completion of the respective Baseline observational periods, all patients will transition to the interventional period where they will receive Triferic. The Triferic will be administered via the liquid bicarbonate or via IV. Once patients enter the interventional period, IV iron will only be administered if ferritin <100 µg/L and Hgb decreases by ≥0.5g/dL from the last value obtained in the observational Baseline period. Patients will remain in the interventional period for either 36 or 28 weeks (depending on randomization assignment), at which time a final study visit will take place.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triferic via IV and Hemodialysate | Experimental | Drug: TrifericUpon completion of the Baseline observational periods, all enrolled patients will transition to the interventional period where they will then receive Triferic. The Triferic will be administered via the liquid bicarbonate concentrate at a dialysate concentration of 2 uM or via IV at a dose of 0.1 mg Fe/kg, if the patient does not receive dialysis using liquid bicarbonate, for up to an additional 36 weeks (depending on duration of observational Baseline period). Hgb and CHr will continue to be measured bi-weekly and iron profiles will be obtained at 4 week intervals. In the Triferic phase of the study,changes in ESA dose will be allowed according to the study site existing protocol. IV iron will only be administered if ferritin meets the criteria for iron deficiency. Patients will remain in the interventional period for either 36 or 28 weeks (depending on randomization assignment), at which time a final study visit will take place |
| Historic Control Observational Arm | No intervention | –Up to 75 patients will be enrolled in the Observational Arm. Patients who participate in the historical control observational arm will not receive any study medication, but will have Hgb, CHr and serum iron profiles collected at 4 week intervals for up to a total of 44 weeks. |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 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 between 6 months and <18 years of age at screening.
- Patient has chronic kidney disease receiving in-center hemodialysis at least twice weekly for at least 3 months 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 (6 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 is receiving intravenous or oral antibiotics or antifungals for any infectious process. (Prophylactic antibiotics administered on a regular basis are allowed. Patients may enter the study once the infection has cleared.)
- Patient has evidence of an ongoing active inflammatory process (e.g., systemic lupus erythematosus, acute or chronic active hepatitis, etc.) requiring treatment.
- Patient has been dosed in an investigational drug study within the 30 days prior to Baseline.
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: FPCFerric Pyrophosphate Citrate | Drug | Triferic via IV and Hemodialysate |
Primary outcome
Assess the incidence of adverse events of Triferic administration via dialysate and IV in pediatric CKD-5HD patients
Time frame: 44 weeks
Incidence and severity of adverse events compared to Baseline.
3 secondary outcomes
Assess the ability of Triferic to maintain hemoglobin in pediatric CKD-5HD patients
Time frame: 44 weeks
Assess the proportion of patients maintaining hemoglobin between 10.5-12.0 g/dL compared to baseline
Time frame: 44 weeks
Assess the change in reticulocyte hemoglobin content (CHr).
Time frame: 44 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 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, Inc
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Triferic in people with End Stage Renal Disease, run by Rockwell Medical Technologies, Inc. at 9 sites in 2 countries.
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 11 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 21 Apr 2021. 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, Puerto Rico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emily Akin (913-485-9082, eakin@georgeclinical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the incidence of adverse events of Triferic administration via dialysate and IV in pediatric CKD-5HD patients (time frame: 44 weeks). 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 21 Apr 2021.