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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 : Recruiting
First Posted : January 27, 2020
Last Update Posted : April 21, 2021
Sponsor:
Information provided by (Responsible Party):
Rockwell Medical Technologies, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Drug: Triferic Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hemoglobin Maintenance in Pediatric ESRD Patients by Ferric Pyrophosphate Citrate (FPC)
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : November 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: Triferic
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Assess the ability of Triferic to maintain hemoglobin in pediatric CKD-5HD patients [ Time Frame: 44 weeks ]
    Change from Baseline in hemoglobin concentration

  2. 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

  3. Assess the change in reticulocyte hemoglobin content (CHr). [ Time Frame: 44 weeks ]
    Change from Baseline in reticulocyte hemoglobin content (CHr).



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

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


Contacts
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Contact: Emily Akin 913-485-9082 eakin@georgeclinical.com
Contact: Terrilyn Sharpe, MSHS 248-819-3088 tsharpe@rockwellmed.com

Locations
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United States, California
Loma Linda University Hospital Recruiting
Loma Linda, California, United States, 92354
Contact: Jacqueline Lopez       JANLopez@llu.edu   
Principal Investigator: Rita Sheth, MD         
United States, District of Columbia
Childrens Hospital National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Nadia Itani       njitani@childrensnational.org   
Principal Investigator: Marva Moxey Mims, MD         
United States, Indiana
Riley Hospital for Children at Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Sherry Wilson       slw2@iu.edu   
Principal Investigator: Neha Pottanat, MD         
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: Stephen Morrison       ssmorison@cmh.edu   
Principal Investigator: Bradley Warady, MD         
United States, North Carolina
Carolina's Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Jennifer Lamothe    704-446-3705    jennifer.lamothe@atriumhealth.org   
Principal Investigator: Donald Weaver, MD         
United States, Ohio
Cincinnati Children's Hospital Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Bliss Magella    513-636-7832    Bliss.Magella@cchmc.org   
Principal Investigator: Francisco Flores, MD         
United States, Texas
University of Texas Health Science Center At San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Sonia Januario       januario@uthscsa.edu   
Principal Investigator: Mazen Arar, MD         
United States, Washington
Childrens Hospital and Medical Center- Seattle Recruiting
Seattle, Washington, United States, 98105
Contact: Megan Kelton    206-987-5539    Megan.Kelton@seattlechildrens.org   
Principal Investigator: Jodi Smith, MD         
Puerto Rico
University of Puerto Rico School of Medicine Recruiting
San Juan, Puerto Rico, 00963-5067
Contact: Marta Suarez, MD    787-759-9595    marta.suarez@upr.edu   
Sponsors and Collaborators
Rockwell Medical Technologies, Inc.
Investigators
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Study Director: Raymond D Pratt, MD FACP Rockwell Medical, Inc
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Responsible Party: Rockwell Medical Technologies, Inc.
ClinicalTrials.gov Identifier: NCT04239391    
Other Study ID Numbers: RMFPC-22
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: April 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Rockwell Medical Technologies, Inc.:
dialysis
pediatric
chronic kidney disease
anemia
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency