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

University of Aarhus71 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Minimal Change Disease Nephrotic Syndrome

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Remission

Time from treatment to remission and the frequency of patients reaching remission on treatment

Time frame: 4 to 16 weeks

Secondary Outcomes

Relapse

Frequency of relapse

Time frame: 4 weeks to 1 year after remission

Side effects to treatment

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.

Time frame: 4 weeks to 1 year after remission

Concentration of Prednisolone in saliva

Measurement of prednisolone metabolism by saliva test and genetic analysis of specific liver enzymes

Time frame: 4 weeks after initiating prednisolone treatment

Rates of genetic polymorphism, including HLA variations

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.

Time frame: Blood test at baseline