CompletedPhase 2

Effect of Pyridorin in Patients With Diabetic Nephropathy

80 participantsStarted 2002-07

Plain-language summary

The primary objective of the study is to evaluate the safety, tolerability and efficacy of Pyridorin (pyridoxamine dihydrochloride) up to 250 mg given orally twice daily in patients with diabetic kidney disease.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Serum Creatinine \<=2.0 mg/dL at weeks -2 and -1 (PYR-205) Serum Creatinine \>2.0 mg/dL but \<=3.5 mg/dL at weeks -2 and -1 (PYR-207)
✓. Urinary albumin excretion \>=300 mg/24 hours at week -2
✓. No other known or suspected etiology for nephropathy

What they're measuring

Change in Serum Creatinine from baseline to week 26

Trial details

NCT IDNCT00320021

SponsorBioStratum

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

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