Ferric Citrate and Chronic Kidney Disease in Children
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 6-17 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 12 core clinical sites.
- Ages 6 to 17 years (inclusive);
- Estimated GFR of 15-59 ml/min per 1.73 m2 by modified CKiD formula;56
- Serum phosphate within age appropriate normal levels;
- Serum ferritin <500 ng/ml and TSAT <50%;
- For those patients treated with growth hormone, calcitriol, nutritional vitamin D, iron, and/or 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.
- Perform physical exam and obtain vitals.
- Check urine pregnancy test in menstruating female participants and administer corresponding questionnaire.
- Administer GI Symptom questionnaire.
- Ascertain AEs.
- Obtain information on concomitant medications.
- Process 24-hour urine sample for 24 hour urine creatinine and phosphate.
- Measure run-in adherence using eCAP system and pill count.
- Administer the Medical Adherence Measure tool.
- Reinforce adherence.
- Prepare one month's supply of drug and enter them into eCAP system.