Phosphate Binder Therapy and Chronic Kidney Disease in Children (Fit4Kid)
Overview
The Phosphate Binder Therapy and Chronic Kidney Disease in Children study, also known as the Fit4Kid clinical research trial, is a 12-month, double-blind, randomized, placebo-controlled trial to assess the effects of therapy with ferric citrate on changes in intact FGF23 levels in children with chronic kidney disease stages 3-4.
Population of the study: Children of either sex, aged 6 to 18 years, with chronic kidney disease stages 3-4 and age-appropriate serum phosphate levels
Intervention: Ferric citrate tablets, divided into three doses to be taken with meals
Control: Placebo tablets, divided into three doses to be taken with meals
Outcome:
- Primary Endpoint: intact FGF23 level
- Secondary Endpoints:
- Anemia
- Indices of mineral and bone metabolism
Trial Information
Target Enrollment: 160 participants
Funder: National Institutes of Health (NIH)/National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Duration of Study: Study 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 Principal Investigator
The Institute for Clinical Research and Learning Health Care
McGovern Medical School at UTHealth Houston
6431 Fannin, MSB 3.502
Houston, TX 77030
(p): 713-500-5670
Links