Randomized controlled trial of corticosteroid tapering in steroid-sensitive podocytopathy
File(s)
Published version (pre-proof)
Author(s)
Jha, Vivek
Type
Journal Article
Abstract
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.
Materials and Methods
This was a randomized, parallel-group, active-controlled, non-inferiority 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 one of two 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% patients in the short-course group and 57.8% in the standard-course group, meeting the prespecified criteria for non-inferiority (absolute difference 5.5%; lower bound of the CI −14.3%; one-sided p-value for non-inferiority=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 non-inferior to a prolonged taper in preventing relapses in adults with steroid-sensitive podocytopathy, with a lower incidence of adverse events.
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.
Materials and Methods
This was a randomized, parallel-group, active-controlled, non-inferiority 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 one of two 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% patients in the short-course group and 57.8% in the standard-course group, meeting the prespecified criteria for non-inferiority (absolute difference 5.5%; lower bound of the CI −14.3%; one-sided p-value for non-inferiority=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 non-inferior to a prolonged taper in preventing relapses in adults with steroid-sensitive podocytopathy, with a lower incidence of adverse events.
Date Issued
2026-08-05
Date Acceptance
2026-07-28
Citation
Kidney International Reports, 2026
ISSN
2468-0249
Publisher
Elsevier
Journal / Book Title
Kidney International Reports
Copyright Statement
© 2026 Published by Elsevier Inc. on behalf of the International Society of Nephrology.
Publication Status
Published online
Article Number
107004
Date Publish Online
2026-08-05