Kidney international · 2026
A randomized controlled non-inferiority trial examined lower dose prednisolone and activated vitamin D in adult minimal change podocytopathy.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеEquivalence TrialПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Kristensen Tilde, Tougaard Birgitte, Thuesen Anne Daugaard, Peters Christian Daugaard, Hansen Ditte, Rydahl Casper, Borg Rikke, Lyngsø Cecilie, Mose Frank Holden, Bech Jesper, Gramkow Ann-Maria, Gregersen Jon W, Pedersen Birgitte Bang, Resuli Marsela, Birn Henrik, Ivarsen Per
Аннотация
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 3.7 g vs 8.0 g, respectively. The number of serious adverse events were less and glucocorticoid-related toxicities (46 [11-77] vs. 74 [30-119]) were significantly less in the lower-dose/ alfacalcidol group than the high-dose group, respectively.
CONCLUSIONS: Non-inferiority was not reached for the combined intervention with lower dose prednisolone and alfacalcidol compared to standard prednisolone treatment. But the combined treatment offers a safer alternative to high-dose prednisolone for treatment of MCD, with similar efficacy but fewer serious adverse events and reduced glucocorticoid toxicity.
TRIAL REGISTRATION: Registered at ClinicalTrials.gov with study number NCT03210688.
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 3.7 g vs 8.0 g, respectively. The number of serious adverse events were less and glucocorticoid-related toxicities (46 [11-77] vs. 74 [30-119]) were significantly less in the lower-dose/ alfacalcidol group than the high-dose group, respectively.
CONCLUSIONS: Non-inferiority was not reached for the combined intervention with lower dose prednisolone and alfacalcidol compared to standard prednisolone treatment. But the combined treatment offers a safer alternative to high-dose prednisolone for treatment of MCD, with similar efficacy but fewer serious adverse events and reduced glucocorticoid toxicity.
TRIAL REGISTRATION: Registered at ClinicalTrials.gov with study number NCT03210688.