NCT01308242

Effects of a Non-Calcium Based Phosphate Binder on FGF23 Levels in Chronic Kidney Disease

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Fibroblast Growth Factor 23 (FGF23) is a molecule that has been implicated in the homeostasis of phosphorus. Elevated FGF23 levels are well-documented in patients with Chronic Kidney Disease (CKD) and are inversely correlated with Glomerular Filtration Rate (GFR). FGF23 levels are also predictive of progression of CKD and predict mortality in CKD. Although studies in normal individuals suggest that phosphorus intake is related to FGF23 levels, the effect of dietary and pharmacologic phosphate restriction on FGF23 levels in patients with CKD has never been reported. Our objectives are to determine if phosphate reduction through the use of non-calcium based phosphate binder will decrease serum FGF23 levels. The investigators will also be investigating associations of elevation in FGF 23 levels with commonly encountered co-morbidities in CKD patients such as Coronary Artery Disease, Diabetes Mellitus, and Hypertension.

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Sevelamer Carbonate	Sevelamer 800 mg by mouth three times daily with meals for 3 months

Timeline

• Start date: 2011-03-01
• Primary completion: 2014-02-27
• Completion: 2014-02-27
• First posted: 2011-03-04
• Last updated: 2018-05-02

Locations

1 site across 1 country: United States