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news.Study to evaluate Pyridorin to treat type 2 diabetic patients with overt diabetic nephropathy
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NephroGenex has completed patient enrollment in its phase 2b clinical trial (PYR-210) studying the safety and efficacy of its lead drug candidate Pyridorin (pyridoxamine dihydrochloride) in type 2 diabetic patients with overt diabetic nephropathy.
Reportedly, 317 patients have been randomised. The study is being conducted by the Collaborative Study Group (CSG) at approximately 65 sites in the US, Australia and Israel.
The trial is evaluating two doses of Pyridorin against placebo in approximately 300 patients for a one year treatment period. Recruited type 2 diabetic patients have elevated serum creatinine levels and significant proteinuria. The estimated study completion date is August 2010.
The company said that the trial is incorporating the latest discussion with the FDA regarding the use of an approvable surrogate endpoint that would be subsequently confirmed with hard clinical endpoints.
In previous phase 2a trials, Pyridorin therapy has demonstrated a significant treatment effect in slowing the progression of diabetic nephropathy as measured by the change in serum creatinine and serum cystatin C over six months, as well as a reduction in urine TGF-beta.