Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    Rockwell | Child
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04239391
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
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.

Layout table for study information
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)
Estimated Study Start Date : January 30, 2020
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : September 1, 2022

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Layout table for location contacts
Contact: Emily Akin 913-485-9082 eakin@georgeclinical.com
Contact: Terrilyn Sharpe, MSHS 248-819-3088 tsharpe@rockwellmed.com

Locations
Layout table for location information
Puerto Rico
University of Puerto Rico School of Medicine
San Juan, Puerto Rico, 00963-5067
Contact: Marta Suarez         
Sponsors and Collaborators
Rockwell Medical Technologies, Inc.
Investigators
Layout table for investigator information
Study Director: Raymond D Pratt, MD FACP Rockwell Medical, Inc
Layout table for additonal information
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: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency