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

Milton S. Hershey Medical Center1 site in 1 country40 target enrollmentMarch 2011

ConditionsChronic Kidney Disease

InterventionsSevelamer Carbonate

DrugsSevelamer Carbonate

Overview

Phase: Early Phase 1
Intervention: Sevelamer Carbonate
Conditions: Chronic Kidney Disease
Sponsor: Milton S. Hershey Medical Center
Enrollment: 40
Locations: 1
Primary Endpoint: Effects of a Non-Calcium Based Phosphate Binder on FGF23 Levels in Chronic Kidney Disease
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 2011

End Date

February 27, 2014

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Milton S. Hershey Medical Center

Responsible Party

Sponsor

Eligibility Criteria

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.