Diabetic Nephropathy

Clinical Trials

Below is a list of Diabetic Nephropathy clinical trials from the clinical trials database at Mayo Clinic.

This list includes only trials about which Mayo researchers choose to publish information. Mayo Clinic may be conducting other trials which are not in this database. Mayo's clinical trials include experimental treatments, often unavailable elsewhere, which frequently lead to improved patient care for people worldwide. Patients should ask their doctor at Mayo about clinical trials appropriate for their situation.

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase 2b Study to Evaluate the Safety and Efficacy of Pyridorin (pyridoxamine dihydrochloride) in Patients with Nephropathy Due to Type 2 Diabetes
Kidney disease develops in an estimated 10% to 40% of patients with type 2 diabetes. Although angiotensin-converting enzyme inhibitors (ACE-I) and angiotensin II receptor blockers (ARB) have been shown to slow the progression of diabetic nephropathy and delay the onset of end-stage renal disease (ESRD), they do not prevent this ultimate outcome. In the United States and Europe, diabetic nephropathy represents the most frequent cause of ESRD.

Diabetic nephropathy, and in particular ESRD, is extremely costly, both in terms of medical treatment and lost productivity. Treatments that prevent the development or progression of diabetic nephropathy will meet a significant medical need and may provide a significant cost savings to the healthcare system.
The Diabetes Control and Complications Trial and the UK Prospective Diabetes Study have demonstrated that intensified glycemic control reduces the development and progression of diabetic microvascular complications including nephropathy, retinopathy, and neuropathy.

One possible mechanism by which hyperglycemia-induced microvascular complications may occur is through the formation of advanced glycation end-products (AGEs). Advanced glycation end-products are formed via condensation of glucose with proteins to form a Schiff base which subsequently undergoes rearrangement to form an Amadori-intermediate. The Amadori-intermediate then undergoes oxidation to irreversibly form AGEs. By a post-Amadori mechanism, Pyridorin inhibits AGE formation and has demonstrated evidence of efficacy in preclinical models of diabetic nephropathy, as well as preliminary evidence of efficacy in patients with nephropathy and diabetes in Phase 2 clinical trials. Based on these data, Pyridorin is being further evaluated for the treatment of diabetic nephropathy due to type 2 diabetes.
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