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

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ClinicalTrials.gov Identifier: NCT01308242
Recruitment Status : Unknown
Verified February 2011 by Penn State University.
Recruitment status was:  Recruiting
First Posted : March 4, 2011
Last Update Posted : March 4, 2011
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by:
Penn State University

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 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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Sevelamer Carbonate Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Effects of a Non-Calcium Based Phosphate Binder on FGF23 Levels in Chronic Kidney Disease
Study Start Date : March 2011
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Treatment
Patients enrolled will receive Renvela for a 3 month time frame.
Drug: Sevelamer Carbonate
Sevelamer 800 mg by mouth three times daily with meals for 3 months
Other Name: Renvela



Primary Outcome Measures :
  1. Effects of a Non-Calcium Based Phosphate Binder on FGF23 Levels in Chronic Kidney Disease [ Time Frame: March 2011-June 2012 ]
    Determine if phosphate reduction through the use of non-calcium based phosphate binders will decrease serum FGF23 levels



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01308242


Contacts
Contact: Christin Spatz, MD 717-531-8156 cspatz@hmc.psu.edu
Contact: Navin Verma, MD 717-531-8156 nverma@hmc.psu.edu

Locations
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Christin Spatz, MD    717-531-8156    cspatz@hmc.psu.edu   
Sponsors and Collaborators
Penn State University
Genzyme, a Sanofi Company

Responsible Party: Christin Spatz M.D., Penn State University
ClinicalTrials.gov Identifier: NCT01308242     History of Changes
Other Study ID Numbers: 33139CS
First Posted: March 4, 2011    Key Record Dates
Last Update Posted: March 4, 2011
Last Verified: February 2011

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Sevelamer
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action