Pyridoxamine Dihydrochloride in Diabetic Nephropathy (PIONEER-CSG-17): Lessons Learned from a Pilot Study | Zendy

Jamie P. Dwyer | Zendy; Barbara Greco | Zendy; Kausik Umanath | Zendy; David Packham | Zendy; J Wesley Fox | Zendy; Robert Peterson | Zendy; Benjamin R Broome | Zendy; Laura E Greene | Zendy; Mohammed Sika | Zendy; Julia B. Lewis | Zendy

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Pyridoxamine Dihydrochloride in Diabetic Nephropathy (PIONEER-CSG-17): Lessons Learned from a Pilot Study

Author(s) -

Jamie P. Dwyer,

Barbara Greco,

Kausik Umanath,

David Packham,

J Wesley Fox,

Robert Peterson,

Benjamin R Broome,

Laura E Greene,

Mohammed Sika,

Julia B. Lewis

Publication year - 2014

Publication title -

the nephron journals/nephron journals

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 0.951

H-Index - 72

eISSN - 2235-3186

pISSN - 1660-8151

DOI - 10.1159/000369310

Subject(s) - medicine , pyridoxamine , creatinine , nephropathy , renal function , diabetic nephropathy , endocrinology , urology , diabetes mellitus , vitamin b6 , vitamin

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.

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