Effects of a Non-Calcium Based Phosphate Binder on FGF23 Levels in Chronic Kidney Disease
Recruitment status was Recruiting
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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 |
- 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 |
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| Contact: Christin Spatz, MD | 717-531-8156 | cspatz@hmc.psu.edu |
| Contact: Navin Verma, MD | 717-531-8156 | nverma@hmc.psu.edu |
| 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 | |
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 Kidney Failure, Chronic Urologic Diseases Renal Insufficiency |
Sevelamer Chelating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 13, 2013