Hemoglobin Maintenance in Pediatric ESRD (End-stage Renal Disease) Patients by Ferric Pyrophosphate Citrate (FPC)

End Stage Renal Disease Clinical Trial

Official title:

Hemoglobin Maintenance in Pediatric ESRD Patients by Ferric Pyrophosphate Citrate (FPC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04239391
• Other study ID #: RMFPC-22
• Status: Recruiting
• Phase: Phase 3
• Start date: September 1, 2020
• Est. completion date: November 1, 2023

Study information

• Verified date: February 2021
• Source: Rockwell Medical Technologies, Inc.
• Contact: Emily Akin
• Phone: 913-485-9082
• Email: eakin[@]georgeclinical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 1, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 17 Years

Eligibility

Inclusion Criteria:

A patient will be eligible for inclusion in the study only if all of the following criteria

are met:

1. 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.

2. Patient is between 6 months and <18 years of age at screening.

3. Patient has chronic kidney disease receiving in-center hemodialysis at least twice weekly for at least 3 months prior to screening.

4. Patient is receiving adequate hemodialysis as assessed by the investigator and based on a single pool Kt/V measurement >1.2.

5. Patient has a vascular access (tunneled catheter, AV fistula or AV graft) suitable to support blood flows for hemodialysis treatment.

6. Patient has a body mass of =11 lbs (5 kg).

7. Patient is iron-replete as measured by a TSAT = 20% and a ferritin >100 µg/L at screening.

8. Patient has a whole blood Hgb concentration of = 9.5 g/dL at screening.

9. 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.

10. 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. Exclusion Criteria: A patient will not be eligible for inclusion in the study if any of the following criteria

apply:

1. Patient is positive for human immunodeficiency virus (HIV) or hepatitis B by history.

2. 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.)

3. Patient has evidence of an ongoing active inflammatory process (e.g., systemic lupus erythematosus, acute or chronic active hepatitis, etc.) requiring treatment.

4. Patient has been dosed in an investigational drug study within the 30 days prior to Baseline.

5. 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).

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Drug:
• Triferic
Ferric Pyrophosphate Citrate

Locations

Country	Name	City	State
Puerto Rico	University of Puerto Rico School of Medicine	San Juan
United States	Carolina's Medical Center	Charlotte	North Carolina
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	Riley Hospital for Children at Indiana University	Indianapolis	Indiana
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	Loma Linda University Hospital	Loma Linda	California
United States	University of Texas Health Science Center At San Antonio	San Antonio	Texas
United States	Childrens Hospital and Medical Center- Seattle	Seattle	Washington
United States	Childrens Hospital National Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Rockwell Medical Technologies, Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	44 weeks
Secondary	Assess the ability of Triferic to maintain hemoglobin in pediatric CKD-5HD patients	Change from Baseline in hemoglobin concentration	44 weeks
Secondary	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	44 weeks
Secondary	Assess the change in reticulocyte hemoglobin content (CHr).	Change from Baseline in reticulocyte hemoglobin content (CHr).	44 weeks