The Effects of Sevelamer Carbonate on Diabetic Nephropathy

Completed · Phase 2

Conditions studied: Diabetic Nephropathy

In brief

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 food in people with diabetes, this simple change lowers different risks for heart disease and the worsening of kidney disease. The investigators focus on a specific type of oxidant, advanced glycation endproducts (AGEs). A previous, smaller study, conducted by our group showed that a drug, already approved by the FDA, will lower AGEs in the investigators compared Renvela® to Tums®. Both of these drugs have few side effects and have been used for a long time in patients with diabetes and kidney disease. While our previous study was interesting, it was just too small to be able to be sure that it will help all people with diabetes, or if the good effects the investigators found were simply due to chance. The investigators are doing this new study to confirm or deny the possibility that Renvela® can really help people with diabetes and kidney disease.

Key facts

Study ID

NCT01493050

Run by

Gary Striker

People needed

117

Starts

2012-02-01

Expected to finish

2013-12-01

Last updated by the study team

2014-04-09

Who can join

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

You may qualify if…

• 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%

You may not qualify if…

• 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.

Where it is running

• Beth Israel Medical Center — New York, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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