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

NCT01308242 | Completed Early Phase 1

• 1 other identifier: 33139CS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Treatment

EXPERIMENTAL

Patients enrolled will receive Renvela for a 3 month time frame.

Drug: Sevelamer Carbonate

Interventions

Sevelamer Carbonate DRUG

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

Also known as: Renvela

Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Sevelamer

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyamines; Amines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2011
• First Posted: March 4, 2011
• Study Start: March 1, 2011
• Primary Completion: February 27, 2014
• Study Completion: February 27, 2014
• Last Updated: May 2, 2018

Record last verified: 2018-04

Locations

US (1)