Pyridoxamine Dihydrochloride in Diabetic Nephropathy (PIONEER-CSG-17): Lessons Learned from a Pilot Study
Jamie P Dwyer, Barbara A Greco, Kausik Umanath, David Packham, J Wesley Fox, Robert Peterson, Benjamin R Broome, Laura E Greene, Mohammed Sika, Julia B Lewis
Nephron | KARGER | Published : 2015
BACKGROUND/AIMS: Pyridoxamine dihydrochloride (Pyridorin™) blocks pathogenic oxidative pathways in the progression of diabetic nephropathy. The pyridoxamine pilot study was designed to test entry criteria and outcomes. Subjects had SCr 1.3-3.5 mg/dl, protein-to-creatinine ≥1,200 mg/g and used a surrogate outcome of ΔSCr over 52 weeks. Subjects had to be on a maximally tolerated dose of ACE/ARB for 3 months; stable other antihypertensive doses for 2 months; stable diuretic dose for 2 weeks, and BP ≤160/90 mm Hg; or enter a Pharmaco-Stabilization Phase (PSP). This pilot failed to detect an effect on ΔSCr in intent-to-treat analysis. METHODS: We queried the locked clinical trial database for su..View full abstract
Drs. Dwyer, Umanath, Sika, Lewis, and Ms. Greene report research grant and travel support from NephroGenex, Inc., and Eli Lilly, Inc. Dr. Fox and Mr. Peterson are employees of NephroGenex, Inc. NephroGenex, Inc. is funding this clinical trial. The Collaborative Study Group funded and performed analyses that support the validity of the primary outcome of this trial.