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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01308242

Enrollment

Registered

2011-03-04

Start date

2011-03-31

Completion date

2014-02-27

Last updated

2018-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

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.

Interventions

DRUGSevelamer Carbonate

Sevelamer 800 mg by mouth three times daily with meals for 3 months

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026