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
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT01308242
First received: March 3, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Christin Spatz M.D., Penn State University
ClinicalTrials.gov 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
Sevelamer
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Sequestering Agents

ClinicalTrials.gov processed this record on October 23, 2014