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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01308242
• Other study ID #: 33139CS
• Status: Completed
• Phase: Early Phase 1
• Start date: March 2011
• Est. completion date: February 27, 2014

Study information

• Verified date: April 2018
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 27, 2014
• Est. primary completion date: February 27, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Adults between ages 18-80 years old, with a GFR less than or equal to 50 ml/min/1.73 m2 as determined by the Modification of Diet in Renal Disease (MDRD) formula will be included.

Exclusion Criteria:

• Patients will be excluded if they have a history of renal transplant or are pregnant. In addition, patients with dysphagia, swallowing disorders, severe GI motility disorders, severe constipation, history of major gastrointestinal surgery and patients taking levothyroxine for hypothyroidism will be excluded.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Sevelamer Carbonate
Sevelamer 800 mg by mouth three times daily with meals for 3 months

Locations

Country	Name	City	State
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of a Non-Calcium Based Phosphate Binder on FGF23 Levels in Chronic Kidney Disease	Determine if phosphate reduction through the use of non-calcium based phosphate binders will decrease serum FGF23 levels	March 2011-June 2012