Randomized Controlled Trial of Corticosteroid Tapering in Steroid-Sensitive Podocytopathy

INTRODUCTION: Corticosteroids remain the cornerstone of therapy for podocytopathies, including minimal change disease (MCD) and focal segmental glomerulosclerosis (FSGS), in both adults and children. However, the optimal duration of steroid tapering after remission is uncertain, and current guidelines generally recommend a prolonged taper. In this study, we compared a 2-month taper with a 4-month taper of corticosteroids in adults with steroid-sensitive podocytopathy. METHODS: This was a randomized, parallel-group, active-controlled, noninferiority clinical trial that enrolled adults with steroid-sensitive podocytopathy who achieved clinical remission. Patients with active viral infections or recent use of other immunosuppressive therapies were excluded. After achieving remission, participants were randomized to 1 of the 2 following predefined tapering regimens: a short course (oral prednisolone tapered over 2-months) or a standard course (oral prednisolone tapered over 4-months). The primary outcome was relapse-free remission at 12-months from the initiation of tapering. RESULTS: Of the 118 patients screened for the study, 94 were randomized-49 to the short-course arm and 45 to the standard-course arm. The targeted sample size of 114 patients was not met. Relapse-free remission at 12-months was achieved in 63.3% of patients in the short-course group and 57.8% in the standard-course group, meeting the prespecified criteria for noninferiority (absolute difference 5.5%; lower bound of the confidence interval [CI]: -14.3%; 1-sided P-value for noninferiority = 0.001). Adverse events occurred in 12 (24.5%) patients in the short-course group and 24 (53.3%) in the standard-course group (P = 0.003). CONCLUSION: These findings suggest that a shorter course of corticosteroid tapering is noninferior to a prolonged taper in preventing relapses in adults with steroid-sensitive podocytopathy, with a lower incidence of adverse events.