"Steroids and Azathioprine Versus Steroids Alone in IgAN"

Primary Outcome Measures:

• progression of renal disease, estimated by the time to 50% increase in plasma creatinine from baseline. [ Time Frame: Every month for the first six months, then six months ] [ Designated as safety issue: Yes ]
  

Secondary Outcome Measures:

• evolution of proteinuria over time [ Time Frame: every months for the first six months and then every six months ] [ Designated as safety issue: No ]
  
• safety [ Time Frame: every months for the first six months and then every six months ] [ Designated as safety issue: Yes ]
  

In 1999, we published a multicenter, randomized, controlled trial, which compared a 6-month steroid course with supportive therapy in 86 patients with IgAN. After 5 years of follow-up, the risk of a 50% increase in plasma creatinine from baseline was significantly lower in the treated patients; proteinuria also decreased. However, the effect of steroids seemed to diminish over time. The difference in renal survival was particularly striking up till the third year, but then remained constant. We hypothesised that a six-month course of steroid therapy is not enough to ensure a stable remission, and a more aggressive treatment may be required to obtain long-term better results. At this regard, some studies of combined treatment with corticosteroids and azathioprine found that treatment was effective in preserving renal function and in reducing proteinuria. However, these studies did not clarify whether azathioprine added further benefit to steroids in the long term. We conducted a randomised controlled trial to assess the utility of low-dose azathioprine added to steroids in adult IgAN patients.