Status:
RECRUITING
Ferric Citrate and Chronic Kidney Disease in Children
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Chronic Kidney Diseases
Eligibility:
All Genders
6-18 years
Phase:
PHASE2
Brief 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...
Detailed Description
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 ye...
Eligibility Criteria
Inclusion
- Ages 6 to 18 years (inclusive);
- Estimated Glomerular Filtration Rate (GFR) of 15-59 ml/min per 1.73 m2 by modified Chronic Kidney disease in Children (CKiD) under 25 (U25) formula;56
- Serum phosphate \<=5.9 mg/dl;
- Serum ferritin \<500 ng/ml and TSAT \<50%;
- 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;
- Able to swallow tablets;
- Able to eat at least two meals a day;
- In the opinion of the investigator, willing and able to follow the study treatment regimen and comply with the site investigator's recommendations.
Exclusion
- Patients currently treated with phosphate binders.
- History of allergy to all ingredients (including non-medical ingredients) in both products (i.e. investigational product and placebo)
- Current intestinal malabsorption, documented in the medical record; disease, inflammatory bowel syndrome, and/or Crohn's Disease.
- Anticipated initiation of dialysis or kidney transplantation within 6 months
- Current or planned future systemic immunosuppressive therapy
- Prior solid organ transplantation
- Receipt of bone marrow transplant within two years of screening
- Current pregnancy, lactation or female subjects who have reached menarche, unless using highly-effective contraception as outlined in section 7.1.1 of Protocol
- Patients participating in other interventional study (observational study participation permitted)
- Poor adherence to medical treatments in the opinion of the investigator
- Cystinosis
- Fanconi syndrome
- Hemochromatosis or laboratory tests indicating possible hemochromatosis or other iron overload (primary or secondary) syndrome
Key Trial Info
Start Date :
June 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04741646
Start Date
June 17 2022
End Date
October 1 2027
Last Update
May 2 2025
Active Locations (20)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90095
2
Children's Hospital of Orange County
Orange, California, United States, 92868
3
University of California, San Francisco
San Francisco, California, United States, 94143
4
Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806