drugset / Trial / NCT00755859

"Steroids and Azathioprine Versus Steroids Alone in IgAN"

NCT00755859

Phase 4 Completed 206 enrolled A. Manzoni Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

In a previous trial the investigators found that the effect of steroids in IgA nephropathy diminish over time. The difference in renal survival is striking up till the third year, but then remains constant. A six-month course of steroid therapy may be not enough to ensure a stable remission. The investigators hypothesized that a more aggressive treatment may obtain long-term better results. The investigators conducted a randomised controlled trial to assess the utility of low-dose azathioprine added to steroids in adult IgAN patients.

Timeline

Start
1998-05
Primary completion
2004-12
Completion
2007-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Azathioprine Small molecule 1.5 mg/kg
Background Methylprednisolone Other / unclassified 1 g Intravenous
Background Prednisone Other / unclassified 0.5 mg/kg Oral