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

Completed · Phase 1

Conditions studied: Diabetic Nephropathy

In brief

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.

Key facts

Study ID

NCT00967629

Run by

Icahn School of Medicine at Mount Sinai

People needed

20

Starts

2009-06-01

Expected to finish

2010-02-01

Last updated by the study team

2011-11-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Mount Sinai School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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