FGF-23 (Fibroblast Growth Factor 23) Regulation in Chronic Kidney Disease

University of California, Los Angeles1 site in 1 country18 target enrollmentOctober 2009

ConditionsSecondary Hyperparathyroidism

InterventionsSevelamer Carbonate Placebo

DrugsSevelamer Carbonate

Overview

Phase: Not Applicable
Intervention: Sevelamer Carbonate
Conditions: Secondary Hyperparathyroidism
Sponsor: University of California, Los Angeles
Enrollment: 18
Locations: 1
Primary Endpoint: Change in FGF-23 Level
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

FGF-23 is a newly described protein that is an important regulator of phosphorus in the body. This protein increases in people with kidney disease and people who need dialysis have very high levels of FGF-23 in the blood. However, although some studies have indicated that FGF-23 levels go up with increased intake of phosphorus, no one knows if FGF-23 levels can be lowered in patients with kidney disease by preventing them from absorbing phosphorus from food. This study is designed to see what happens to levels of FGF-23 in the blood when patients with chronic kidney disease take medications to prevent phosphorus absorption. Since high levels of FGF-23 have been linked with increased rates of death in patients with advanced kidney disease, controlling the levels may, in the future, be a way to decrease heart disease in patients with kidney disease.

Registry

clinicaltrials.gov

Start Date

October 2009

End Date

June 2015

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of California, Los Angeles

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Inclusion criteria include pediatric patients, between the ages of 2 and 21 years, with CKD stages 2-4 (GFR 15-90 ml/min/1.73m2).

Exclusion Criteria

•Exclusion criteria include: the use of phosphate binder therapy within the past 3 months, treatment with 25(OH)vitamin D or 1,25dihydroxyvitamin D, underlying metabolic bone disease, or underlying renal phosphate wasting disorder.