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Iron Supplement

Triferic for Kidney Failure

Phase 3
Waitlist Available
Research Sponsored by Rockwell Medical Technologies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 44 weeks
Awards & highlights

Study Summary

This trial is testing whether it is safe to give Triferic iron to children with chronic kidney disease who are on dialysis.

Eligible Conditions
  • Kidney Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~44 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 44 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assess the incidence of adverse events of Triferic administration via dialysate and IV in pediatric CKD-5HD patients
Secondary outcome measures
Assess the ability of Triferic to maintain hemoglobin in pediatric CKD-5HD patients
Assess the change in reticulocyte hemoglobin content (CHr).
Assess the proportion of patients maintaining hemoglobin between 10.5-12.0 g/dL compared to baseline

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Triferic via IV and HemodialysateExperimental Treatment1 Intervention
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
Group II: Historic Control Observational ArmActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ferric pyrophosphate citrate
FDA approved

Find a Location

Who is running the clinical trial?

Rockwell Medical Technologies, Inc.Lead Sponsor
19 Previous Clinical Trials
1,868 Total Patients Enrolled
1 Trials studying Kidney Failure
12 Patients Enrolled for Kidney Failure
Raymond D Pratt, MD FACPStudy DirectorRockwell Medical, Inc
3 Previous Clinical Trials
82 Total Patients Enrolled

Media Library

Triferic (Iron Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04239391 — Phase 3
Kidney Failure Research Study Groups: Triferic via IV and Hemodialysate, Historic Control Observational Arm
Kidney Failure Clinical Trial 2023: Triferic Highlights & Side Effects. Trial Name: NCT04239391 — Phase 3
Triferic (Iron Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04239391 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I join this clinical trial?

"Up to 150 paediatric patients with chronic kidney disease, who have been receiving hemodialysis treatment for at least 3 months, and weigh more than 11lbs (5kg) are eligible for this study. Additional requirements include that the patient has a suitable vascular access for hemodialysis treatment and is between 6 months and 17 years old."

Answered by AI

Are there any available positions for people who want to participate in this clinical trial?

"Yes, this trial is looking for participants and has been since September 1st, 2020 according to the information available on clinicaltrials.gov."

Answered by AI

Has Triferic been cleared by the FDA?

"Triferic is estimated to be a safe medication, as it has received a score of 3. This is due in part because Triferic is a Phase 3 trial drug, meaning that there are multiple rounds of data supporting both its efficacy and safety."

Answered by AI

How many total people have signed up to participate in this research project?

"This particular clinical study necessitates 150 individuals that fit the required profile. Locations where this research will take place include Riley Hospital for Children at Indiana University in Indianapolis, Indiana and Loma Linda University Hospital in Loma Linda, California - both of which are operated by the sponsor, Rockwell Medical Technologies, Inc.."

Answered by AI

Are numerous hospitals in the United States conducting this research?

"A few of the 8 locations where this trial is recruiting patients include Riley Hospital for Children at Indiana University in Indianapolis, Indiana; Loma Linda University Hospital in Loma Linda, California; and Cincinnati Children's Hospital in Cincinnati, Ohio."

Answered by AI

Are there other documented cases of Triferic's efficacy?

"Triferic's clinical trials are ongoing, with 1 Phase 3 study in progress. Most of these trials are based out of Kansas City, although there are 9 locations total running Triferic trials."

Answered by AI

Is this the first time this type of trial has been conducted?

"Triferic has been under clinical scrutiny since 2020 when it was first studied by Rockwell Medical Technologies, Inc. Since then, there have been 150 participants in various trials leading up to its Phase 3 approval. Currently, there is one ongoing trial for Triferic being conducted by Rockwell Medical Technologies, Inc.."

Answered by AI

If I am not yet a senior citizen, can I still qualify for this particular medical research program?

"The age requirements for potential participants in this study are that they must be between 6 months and 17 years old."

Answered by AI
~33 spots leftby Mar 2025