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

Not Applicable

Completed

• Conditions: Secondary Hyperparathyroidism
• Interventions: Other: Placebo; Drug: Sevelamer Carbonate

• Registration Number: NCT00999037
• Lead Sponsor: University of California, Los Angeles

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-20
• Study First Submitted QC: 2009-10-20
• Study First Posted: 2009-10-21
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Results First Submitted: 2016-12-22
• Results First Submitted QC: 2017-02-14
• Results First Posted: 2017-03-31
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-03
• Last Update Posted: 2023-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	-
Renvela	Sevelamer Carbonate	Daily renvela with meals for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change in FGF-23 Level	12 weeks	Change in FGF23 value from baseline in response to Renvela at 12 weeks in comparison to placebo.

Secondary Outcome Measures

Name	Time	Method
1,25(OH)2vitamin D Value	12 week	Percentage change in 1,25(OH)2vitamin D level from baseline at 12 weeks.
Serum Phosphate Concentration	12 weeks	Change in serum phosphate at 12 weeks from baseline

Trial Locations

Locations (1)

UCLA; 🇺🇸 Los Angeles, California, United States