Effect of Sevelamer Carbonate on Oxidative Stress in Patients With Diabetic Nephropathy

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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 to decrease body AGE load and therefore decreases the inflammation and oxidative stress in these patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Treatments: Calcium; Calcium Carbonate; Calcium, Dietary; Sevelamer

Criteria

Inclusion Criteria:

1. Age ≥ 18 years old

2. 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

3. Proteinuria on urinalysis on two occasions within 18 months of recruitment

4. Diagnosis of diabetes and receiving at least one medication for diabetes mellitus.

Exclusion Criteria:

1. Age < 18 years old

2. Stage I and V CKD

3. Patients receiving active treatment for hyperphosphatemia.

4. Biopsy proven renal disease other than diabetic nephropathy

5. Hypophosphatemia

6. Hypercalcemia

7. any history of significant gastrointestinal disorders

8. any history of significant gastrointestinal surgery such as ileostomy, colostomy and colectomy