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news.US-based pharmaceutical firm NephroGenex (NRX) has entered into collaborations with two research organizations Collaborative Study Group (CSG) and Medpace to carry out its Phase III PIONEER (PyrIdOriN in DiabEtic NEphRopathy) trial of Pyridorin for the treatment of diabetic nephropathy.
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CSG is nephrology academic research organization with 300 affiliated clinics worldwide, while Medpace is contract research organization (CRO) with demonstrated expertise and experience in nephrology.
NRX expects to launch the first of two Phase III trials in the first half of 2014.
NephroGenex chief executive officer Pierre Legault said the company is happy to have onboard the capabilities of CSG and Medpace as it launches its late-stage program in diabetic kidney disease.
"Both organizations were instrumental in conducting our previous Phase 2b study, through which we were able to identify a Phase 3 patient population accepted by the FDA under a Special Protocol Assessment," Legault said.
"These collaborations give NephroGenex the reach and expertise required to successfully execute the oral Pyridorin Phase 3 PIONEER program through to regulatory submission."
The Pyridorin Special Protocol Assessment (SPA) includes a new, fully approvable endpoint (50% serum creatinine increase versus 100%) that will reduce by about half the patient follow-up time and cost.
The company said that pPyridorin inhibits pathogenic oxidative chemistries which are collectively a group of oxygen-based chemical reactions that are elevated in diabetic patients and induce pathological changes in tissues including blood vessels and the kidney.