Ferric Citrate and Chronic Kidney Disease in Children

a study on Chronic Kidney Disease Kidney Disease

Summary

Eligibility
for people ages 6-18 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

We will conduct a 12-month, double-blind, randomized, placebo-controlled trial to assess the effects of therapy with ferric citrate (FC) on changes in intact FGF23 levels (iFGF23, primary endpoint) in 160 pediatric patients (80 in each of the two arms) aged 6-18 years of either sex with chronic kidney disease (CKD) stages 3-4 and age-appropriate normal serum phosphate levels. Participants will be randomized to one of the two groups: 1) FC or 2) FC placebo. Participants will be recruited from 20 core clinical sites.

Official Title

Phosphate Binder Therapy and Chronic Kidney Disease in Children

Details

We will conduct a double-blind, randomized, placebo-controlled trial to assess the effects of therapy with ferric citrate (FC) on changes in intact FGF23 levels (iFGF23, primary endpoint) aged 6-18 years of either sex with chronic kidney disease (CKD) stages 3-4 and age-appropriate normal serum phosphate levels. Participants will be randomized to one of the two groups: 1) FC or 2) FC placebo. Participants will be recruited from 20 core clinical sites.

Schedule of Intervention: During the 12-month trial, participants will be given a daily fixed weight-based dose of FC.

Schedule for data collection/analyses to be performed:

Blood for primary outcome assessments will be collected at screening, baseline and at months 3, 6, 9, 12. Blood for safety assessments will be collected at the same intervals.

The primary analyses for this 2-arm trial will evaluate changes from baseline in iFGF23 levels over 12 months between the treatment and the placebo arms. The analysis will use a linear mixed-effects model, with random participant effects accounting for repeated measurements, random site effects accounting for clustering of participants into study sites, and a fixed treatment effect, which interacts with a time indicator (Months 3-12 vs. Baseline/Screening).

Primary objectives:

  • To assess the effects of therapy with FC on changes in iFGF23 levels
  • To determine safety and tolerability of FC.

Secondary objectives:

• To assess the effects of FC on anemia and indices of mineral and bone metabolism.

Primary Endpoint:

• Change in iFGF23 level

Safety and Tolerability Endpoints:

• Ability to safely tolerate FC

Secondary Endpoints:

  • Change in anemia
  • Change in the indices of mineral and bone metabolism

This is a Phase 2 study with participation from 20 sites that will take 36 months to complete enrollment and a total of 48 months to complete data collection with each participant being part of the study for 12 months.

Study website: fit4kid.dgsom.ucla.edu

Keywords

Chronic Kidney Diseases, Pediatric, CKD, Phosphate Binder, Kidney Diseases, Chronic Renal Insufficiency, Ferric Citrate

Eligibility

You can join if…

Open to people ages 6-18

  1. Ages 6 to 18 years (inclusive);
  2. Estimated Glomerular Filtration Rate (GFR) of 15-59 ml/min per 1.73 m2 by modified Chronic Kidney disease in Children (CKiD) formula;56
  3. Serum phosphate within age appropriate normal levels;
  4. Serum ferritin <500 ng/ml and TSAT <50%;
  5. For those patients treated with growth hormone, calcitriol, nutritional vitamin D, iron, and/or erythropoiesis-stimulating agents (ESAs) such treatments must have stable dosing for at least 2 weeks prior to screening;
  6. Able to swallow tablets;
  7. Able to eat at least two meals a day;
  8. In the opinion of the investigator, willing and able to follow the study treatment regimen and comply with the site investigator's recommendations.

You CAN'T join if...

  1. Patients currently treated with phosphate binders.
  2. History of allergy to all ingredients (including non-medical ingredients) in both products (i.e. investigational product and placebo)
  3. Current intestinal malabsorption, documented in the medical record; significant GI disorders including GI bleeding or active inflammatory bowel disease, inflammatory bowel syndrome, and/or Crohn's Disease
  4. Anticipated initiation of dialysis or kidney transplantation within 6 months
  5. Current or planned future systemic immunosuppressive therapy
  6. Prior solid organ transplantation
  7. Receipt of bone marrow transplant within two years of screening
  8. Current pregnancy, lactation or female subjects who have reached menarche, unless using highly-effective contraception as outlined in section 7.1.1 of Protocol
  9. Patients participating in other interventional study (observational study participation permitted)
  10. Poor adherence to medical treatments in the opinion of the investigator
  11. Hemochromatosis or laboratory tests indicating possible hemochromatosis or other iron overload (primary or secondary) syndrome
  12. Cystinosis
  13. Fanconi syndrome

Locations

  • UCSF accepting new patients
    San Francisco California 94143 United States
  • University of California, Los Angeles accepting new patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT04741646
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 160 study participants
Last Updated