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

University of Aarhus

Status and phase: Completed; Phase 4

Conditions: Minimal Change Disease; Nephrotic Syndrome

Treatments: Drug: Alfacalcidol; Drug: Prednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT03210688

ADAPT in MCN

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

High dose prednisolone

Active Comparator group

Description:

Prednisolone 1 mg/kg/day

Treatment:

Drug: Prednisolone

Alfacalcidol and low dose prednisolone

Experimental group

Description:

Alfacalcidol 0,5 microgram/day and Prednisolone 0,5 mg/kg/day

Treatment:

Drug: Prednisolone

Drug: Alfacalcidol