Active Vitamin D And Reduced Dose Prednisolone for Treatment in Minimal Change Nephropathy (ADAPTinMCN)

Treatment of Primary Minimal Change Nephropathy: A Randomized Open-labeled Non-inferiority Study on Prednisolone and Vitamin D

Traditionally MCN is treated with a high dose of prednisolone, which induces remission in 60-90% of patients. Prednisolone treatment contains numerous side effects and the current dose is empiric. Given the lack of efficacy evidence and the risk associated with the currently accepted treatment regimen there is a need to characterize the outcome in MCN further, and to establish new, and potentially less toxic treatment regimens. The aim is to examine if treatment with reduced dose of prednisolone in combination with activated vitamin D is as effective as standard high dose prednisolone in achieving remission and preventing relapse in MCN, and if reduced dose prednisolone is associated with fewer side effects compared to standard dose. Furthermore, the study will examine the influence of prednisolone metabolism on the efficacy and side effects of prednisolone in the treatment of MCN.

The side effects to prednisolone are assessed using questionnaires by both patients and doctors, including SF36 and Cushing QoL. The Glucocorticoid Toxicity Index will be used to quantitate prednisolone-related morbidity.

Genomic HLA typing (HLA-class I: A, B and C and HLA-class II: DM, DO, DP, DQ and DR) will be performed to examine if specific HLA-alleles are more frequent in patients with MCN. Potential modifying genes that theoretically have pathophysiological impact on MCN will be sequenced using targeted next generation sequencing.

Inclusion Criteria: Biopsy proven minimal change nephropathy If earlier minimal change: No relapse in 5 years, and earlier only treated with prednisolone Nephrotic syndrome Age more than 18 years Exclusion Criteria: Cancer except from basal cells carcinoma Lymphoproliferative disease Pregnancy eGFR < 30 ml/min/1,73m2 (CKD-EPI) Allergy No danish language No ability to give informed prove

Azukaitis K, Palmer SC, Strippoli GF, Hodson EM. Interventions for minimal change disease in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2022 Mar 1;3(3):CD001537. doi: 10.1002/14651858.CD001537.pub5.

Kristensen T, Birn H, Ivarsen P. A randomised controlled unblinded multicentre non-inferiority trial with activated vitamin D and prednisolone treatment in patients with minimal change nephropathy (ADAPTinMCN). Trials. 2021 Jul 12;22(1):442. doi: 10.1186/s13063-021-05393-4.