Hemoglobin Maintenance in Pediatric ESRD (End-stage Renal Disease) Patients by Ferric Pyrophosphate Citrate (FPC)
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|ClinicalTrials.gov Identifier: NCT04239391|
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|End Stage Renal Disease||Drug: Triferic||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hemoglobin Maintenance in Pediatric ESRD Patients by Ferric Pyrophosphate Citrate (FPC)|
|Estimated Study Start Date :||January 30, 2020|
|Estimated Primary Completion Date :||August 31, 2022|
|Estimated Study Completion Date :||September 1, 2022|
Experimental: Triferic via IV and Hemodialysate
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
Ferric Pyrophosphate Citrate
Other Name: FPC
No Intervention: Historic Control Observational Arm
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.
- 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.
- Assess the ability of Triferic to maintain hemoglobin in pediatric CKD-5HD patients [ Time Frame: 44 weeks ]Change from Baseline in hemoglobin concentration
- Assess the proportion of patients maintaining hemoglobin between 10.5-12.0 g/dL compared to baseline [ Time Frame: 44 weeks ]Proportion of patients maintaining hemoglobin between 10.5 - 12.0 g/dL compared toBaseline
- Assess the change in reticulocyte hemoglobin content (CHr). [ Time Frame: 44 weeks ]Change from Baseline in reticulocyte hemoglobin content (CHr).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04239391
|Contact: Emily Akinemail@example.com|
|Contact: Terrilyn Sharpe, MSHSfirstname.lastname@example.org|
|University of Puerto Rico School of Medicine|
|San Juan, Puerto Rico, 00963-5067|
|Contact: Marta Suarez|
|Study Director:||Raymond D Pratt, MD FACP||Rockwell Medical, Inc|