A randomized controlled non-inferiority trial examined lower dose prednisolone and activated vitamin D in adult minimal change podocytopathy
作者:Tilde Kristensen, Birgitte Tougaard, Anne Daugaard Thuesen, Christian Daugaard Peter, Ditte Hansen, Casper Rydahl, Rikke Alvilde Borg, Cecilie Lyngsø, Frank Holden Mose, Jesper Nørgaard Bech, Ann‐Maria Gramkow, Jon Waarst Gregersen, Birgitte Bang Pedersen, Marsela Resuli, Henrik Birn, Per Ivarsen · 发表于:Kidney International · 年份:2026 · DOI:10.1016/j.kint.2026.02.035 · 被引用次数:1 · 研究领域:Lymphatic System and Diseases、Renal Diseases and Glomerulopathies、Lymphatic Disorders and Treatments
INTRODUCTION: Minimal change disease (MCD) is a frequent cause of nephrotic syndrome in adults. Standard treatment consists of high-dose prednisolone (1 mg/kg/d), which induces remission in over 80% of patients but is associated with considerable glucocorticoid toxicity. Here, in the ADAPT trial, we investigated whether a lower dose of prednisolone combined with activated vitamin D (alfacalcidol) could be non-inferior to the standard high-dose regimen in achieving remission. METHODS: In this randomized, open-label, non-inferiority, multicenter trial, 67 adults with MCD were assigned to either lower-dose prednisolone with alfacalcidol or standard high-dose prednisolone. The primary endpoint was remission rate. Secondary endpoints included time to remission, relapse rate, time to relapse, incidence of serious adverse events and glucocorticoid-related toxicity. RESULTS: Although statistical non-inferiority was not established, rates, time to remission and relapse were comparable between groups. Remission was achieved in 88% (95% confidence interval: 74-96) of patients in the lower-dose prednisolone/alfacalcidol group and in 91% (78-98) of those receiving high-dose prednisolone. Median time to remission was 28 days [interquartile range 14-54] versus 23 days [13-47], respectively. Relapses occurred in 35% and 32% of patients, with median times to relapse of 195 days [100-275] and 179 days [161-206], respectively. The total cumulative doses of prednisolone were significantly less 3...