A Phase 3 interventional study of Triferic in End Stage Renal Disease, sponsored by Rockwell Medical Technologies, Inc.. Status unknown at 9 sites in 2 countries. Open to participants aged 6 Months to 17 Years. Per ClinicalTrials.gov, last updated 2021-04-21.
Sponsored by Rockwell Medical Technologies, Inc. · Phase 3, Interventional, and Treatment
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.
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's planned enrollment of 150 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Rockwell Medical Technologies, Inc. is the lead sponsor of 18 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
A patient will be eligible for inclusion in the study only if all of the following criteria are met:
Exclusion Criteria:
A patient will not be eligible for inclusion in the study if any of the following criteria apply:
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
Drug: Triferic
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.
Ferric Pyrophosphate Citrate
Also known as: FPC
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.
Time frame: 44 weeks
Assess the ability of Triferic to maintain hemoglobin in pediatric CKD-5HD patients
Change from Baseline in hemoglobin concentration
Time frame: 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
Time frame: 44 weeks
Assess the change in reticulocyte hemoglobin content (CHr).
Change from Baseline in reticulocyte hemoglobin content (CHr).
Time frame: 44 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Rockwell Medical Technologies, Inc.