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

Secondary Hyperparathyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00999037
• Other study ID #: 1K23DK080984-01A1
• Status: Completed
• Phase: N/A
• Start date: October 2009
• Est. completion date: June 2015

Study information

• Verified date: May 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Diseases
• Renal Insufficiency, Chronic
• Secondary Hyperparathyroidism

Intervention

Drug:
• Sevelamer Carbonate
Daily renvela (800 mg tid with meals) x 12 weeks

Other:
• Placebo
1 inert tablet tid x 12 weeks

Locations

Country	Name	City	State
United States	UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in FGF-23 Level	Change in FGF23 value from baseline in response to Renvela at 12 weeks in comparison to placebo.	12 weeks
Secondary	1,25(OH)2vitamin D Value	Percentage change in 1,25(OH)2vitamin D level from baseline at 12 weeks.	12 week
Secondary	Serum Phosphate Concentration	Change in serum phosphate at 12 weeks from baseline	12 weeks