Status:
COMPLETED
The Effects of Sevelamer Carbonate on Diabetic Nephropathy
Lead Sponsor:
Gary Striker
Conditions:
Diabetic Nephropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to see if taking a medication can lower the amount of oxidants from food that go into our body. Previous research shows that if the investigators lower the oxidants from f...
Detailed Description
Advanced glycation end products (AGEs) levels are elevated in diabetic patients and in patients with chronic kidney disease (CKD) and may contribute to the excessive cardiovascular disease in this pop...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age \> 18 years
- Evidence of CKD Stages II, III or IV
- Stage II CKD; eGFR 60-89 ml/min
- Stage III CKD: eGFR 30-59 ml/min
- Stage IV CKD: eGFR 15-29 ml/min
- Proteinuria (\>200 mg/day or 300 mg/gm creatinine on a spot urine) on urinalysis on two occasions within 18 months of recruitment
- Diagnosis of diabetes and receiving at least one medication for diabetes mellitus
- HbA1c\>6.5%
- Exclusion criteria:
- Age \<18
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT01493050
Start Date
February 1 2012
End Date
December 1 2013
Last Update
April 9 2014
Active Locations (2)
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1
Beth Israel Medical Center
New York, New York, United States, 10003
2
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029