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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Penn State University.
Recruitment status was  Recruiting
Genzyme, a Sanofi Company
Information provided by:
Penn State University Identifier:
First received: March 3, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted

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 Intervention
Chronic Kidney Disease
Drug: Sevelamer Carbonate

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Effects of a Non-Calcium Based Phosphate Binder on FGF23 Levels in Chronic Kidney Disease

Resource links provided by NLM:

Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Effects of a Non-Calcium Based Phosphate Binder on FGF23 Levels in Chronic Kidney Disease [ Time Frame: March 2011-June 2012 ] [ Designated as safety issue: No ]
    Determine if phosphate reduction through the use of non-calcium based phosphate binders will decrease serum FGF23 levels

Estimated Enrollment: 55
Study Start Date: March 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01308242

Contact: Christin Spatz, MD 717-531-8156
Contact: Navin Verma, MD 717-531-8156

United States, Pennsylvania
Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Christin Spatz, MD    717-531-8156   
Sponsors and Collaborators
Penn State University
Genzyme, a Sanofi Company
  More Information

No publications provided

Responsible Party: Christin Spatz M.D., Penn State University Identifier: NCT01308242     History of Changes
Other Study ID Numbers: 33139CS
Study First Received: March 3, 2011
Last Updated: March 3, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases processed this record on February 27, 2015