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The determination of strong scientific leaders keeps trial on track to provide valuable data.

SITUATION

Despite optimal current care, up to 30% of people suffering from IgA nephropathy (IgAN) will develop kidney failure requiring dialysis or kidney transplantation. The largest corticosteroid trial in IgAN completed to date provided valuable and much needed evidence on the risks and benefits of corticosteroids regimens when used in IgAN to delay progression of this disease. This international, multicenter, double-blind, randomized clinical trial enrolled 500+ participants from nearly 70 sites around the world. Although the study was temporarily halted due to high levels of side effects among participants receiving the therapy, recruitment recommenced after trial modifications to a lower-dose regimen.

This unusual study was investigator initiated by the George Institute for Global Health with George Clinical contracted to conduct the study worldwide. Among the George Institute scientific leaders who developed the study and led the Steering Committee (SC) were George Clinical collaborators Prof. Vlado Perkovic (Steering Committee co-chair), Prof. Vivekanand Jha (India National Lead), Prof. David C. Wheeler and Assoc. Prof. Muh Geot Wong (Global co-lead) who also served as a lead investigator.

CHALLENGES

Recruitment was the major challenge, with over 900 patients screened at nearly 70 sites. Based on the advice of the Data Safety and Monitoring Committee (DSMC), the study was halted due to excess adverse events, and an interim analysis of data collected was performed and published. Under the leadership of the SC, the study protocol was modified with ongoing follow-up of all participants. Ultimately only a few more than 500 participants were randomized.