A randomized controlled non-inferiority trial examined lower dose prednisolone and activated vitamin D in adult minimal change podocytopathy.

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.

标准治疗包括大剂量泼尼松龙（每日1 mg/kg），这在超过80%的患者中可以诱导缓解，但与显著的糖皮质激素毒性相关。

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.

在这里，我们通过ADAPT试验研究了较低剂量的泼尼松龙联合活化维生素D（阿法骨化醇）是否能达到与标准高剂量方案相当的缓解效果。

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.

在这项随机、开放标签、非劣效性、多中心试验中，67名患有MCD的成人被分配到低剂量泼尼松龙联合阿法骨化醇组或标准高剂量泼尼松龙组。

The primary endpoint was remission rate.

主要终点是缓解率。

Secondary endpoints included time to remission, relapse rate, time to relapse, incidenceof serious adverse events and glucocorticoid-related toxicity.

次要终点包括缓解时间、复发率、复发时间、严重不良事件的发生率以及糖皮质激素相关的毒性。

Results

Although statistical non-inferiority was not established, rates, time to remission and relapse were comparable between groups.

尽管未确立统计学上的非劣效性，但两组的缓解率、缓解时间和复发时间是可比的。

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.

在低剂量泼尼松/阿法骨化醇组中，88%（95%置信区间：74-96）的患者实现了缓解，在接受高剂量泼尼松治疗的患者中，这一比例为91%（78-98）。

Median time to remission was 28 days [interquartile range 14-54] versus 23 days [13-47], respectively.

缓解的中位时间分别为28天[四分位数间距14-54]和23天[13-47]。

Relapses occurred in 35% and 32% of patients, with median times to relapse of 195 days [100-275] and 179 days [161-206], respectively.

分别有35%和32%的患者出现复发，复发的中位时间分别为195天[100-275]和179天[161-206]。

The total cumulative doses of prednisolone were significantly less 3.7 g vs 8.0 g, respectively.

泼尼松龙的总累积剂量显著较低，分别为3.7克和8.0克。

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.

严重不良事件的数量较少，低剂量/阿法骨化醇组的糖皮质激素相关毒性（46 [11-77] vs. 74 [30-119]）显著低于高剂量组。

Conclusions

Non-inferiority was not reached for the combined intervention with lower dose prednisolone and alfacalcidol compared to standard prednisolone treatment.

与标准泼尼松治疗相比，低剂量泼尼松联合阿法骨化醇的综合干预未达到非劣效性。

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.

但综合治疗为MCD的治疗提供了一种比高剂量泼尼松更安全的替代方案，具有相似的疗效，但严重不良事件较少，糖皮质激素毒性降低。

trial_registration

Registered at ClinicalTrials.gov with study number NCT03210688.

该研究已在ClinicalTrials.gov注册，注册号为NCT03210688。