Effects of Ferric Citrate on Kidney Health in Children
Phosphate Binder Therapy and Chronic Kidney Disease in Children
This study is testing if ferric citrate can help improve kidney health in children aged 6-18 with chronic kidney disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 20 sites (Los Angeles, California and 19 other locations) |
| Trial ID | NCT04741646 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of ferric citrate on intact FGF23 levels in pediatric patients aged 6-18 years with chronic kidney disease stages 3-4. It is a 12-month, double-blind, randomized, placebo-controlled trial involving 160 participants who will be assigned to receive either ferric citrate or a placebo. Blood samples will be collected at various intervals to assess the primary and safety outcomes. The study aims to evaluate both the efficacy and tolerability of ferric citrate in this population.
Who should consider this trial
Good fit: Ideal candidates are children aged 6-18 years with chronic kidney disease stages 3-4 and normal serum phosphate levels.
Not a fit: Patients currently treated with phosphate binders or those with certain gastrointestinal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve kidney health and metabolic outcomes in children with chronic kidney disease.
How similar studies have performed: Previous studies have shown promise in using ferric citrate for similar conditions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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) under 25 (U25) formula;56 3. Serum phosphate \<=5.9 mg/dl; 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. Exclusion Criteria: 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; 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. Cystinosis 12. Fanconi syndrome 13. Hemochromatosis or laboratory tests indicating possible hemochromatosis or other iron overload (primary or secondary) syndrome
Where this trial is running
Los Angeles, California and 19 other locations
- University of California, Los Angeles — Los Angeles, California, United States (Recruiting)
- Children's Hospital of Orange County — Orange, California, United States (Recruiting)
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
- Arnold Palmer Hospital for Children — Orlando, Florida, United States (Recruiting)
- Emory University — Atlanta, Georgia, United States (Recruiting)
- Indiana U — Indianapolis, Indiana, United States (Recruiting)
- Children's Mercy Hospital, Kansas City — Kansas City, Missouri, United States (Recruiting)
- Washington U — St Louis, Missouri, United States (Recruiting)
- Cohen's Childrens — New York, New York, United States (Recruiting)
- Children's Hospital at Montefiore — The Bronx, New York, United States (Recruiting)
- Duke — Durham, North Carolina, United States (Not_yet_recruiting)
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
- Nationwide Children's — Columbus, Ohio, United States (Recruiting)
- Ohsu — Portland, Oregon, United States (Not_yet_recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- Children's Medical Center, Dallas — Dallas, Texas, United States (Recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
- Uth — Houston, Texas, United States (Recruiting)
- BC Children's Hospital Research Institute — Vancouver, British Columbia, Canada (Recruiting)
- SickKids — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Isidro B Salusky, MD — University of California, Los Angeles
- Study coordinator: Jenny Brook, Ms
- Email: jbrook@mednet.ucla.edu
- Phone: 310-7943144
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.