Status:
COMPLETED
Effect of Sevelamer Carbonate on Oxidative Stress in Patients With Diabetic Nephropathy
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Diabetic Nephropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine whether oral sevelamer carbonate binds advanced glycation end products (AGEs) in the gastrointestinal (GI) tract of patients with diabetic nephropathy leading...
Detailed Description
Traditional vascular risk factors alone cannot account for the elevated cardiovascular risk in patients with chronic kidney disease (CKD). In addition to a high prevalence of hypertension and diabetes...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old
- Evidence of CKD II, III or IV Stage II CKD: eGFR 60-89 cc/min Stage III CKD: eGFR 30-59 cc/min Stage IV CKD: eGFR 15-20 cc/min
- Proteinuria on urinalysis on two occasions within 18 months of recruitment
- Diagnosis of diabetes and receiving at least one medication for diabetes mellitus.
Exclusion
- Age \< 18 years old
- Stage I and V CKD
- Patients receiving active treatment for hyperphosphatemia.
- Biopsy proven renal disease other than diabetic nephropathy
- Hypophosphatemia
- Hypercalcemia
- any history of significant gastrointestinal disorders
- any history of significant gastrointestinal surgery such as ileostomy, colostomy and colectomy
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00967629
Start Date
June 1 2009
End Date
February 1 2010
Last Update
November 18 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mount Sinai School of Medicine
New York, New York, United States, 10029