September 9, 2009 - 317 diabetic kidney disease patients enrolled in Phase 2b trial – NephroGenex, Inc., a privately held drug development company focusing on kidney disease, announced the completion of 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. Three hundred and seventeen (317) patients have been randomized.The study is being conducted by the Collaborative Study Group (CSG) at approximately 65 sites in the United States, Australia and Israel. The CSG is a site management organization of nephrologists that has conducted notable landmark studies in diabetic nephropathy in the past, including studies leading to approval of drugs for this indication.
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... [PDF] NephroGenex's Press Release -
