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

Phase 4

Completed

• Conditions: Minimal Change Disease; Nephrotic Syndrome
• Interventions: Drug: Prednisolone; Drug: Alfacalcidol

• Registration Number: NCT03210688
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-03
• Study First Submitted QC: 2017-07-04
• Study First Posted: 2017-07-07
• Study Start: 2018-05-01
• Primary Completion: 2024-02-14
• Status Verified: 2025-01
• Study Completion: 2025-01-21
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose prednisolone	Prednisolone	Prednisolone 1 mg/kg/day
Alfacalcidol and low dose prednisolone	Prednisolone	Alfacalcidol 0,5 microgram/day and Prednisolone 0,5 mg/kg/day
Alfacalcidol and low dose prednisolone	Alfacalcidol	Alfacalcidol 0,5 microgram/day and Prednisolone 0,5 mg/kg/day

Primary Outcome Measures

Name	Time	Method
Remission	4 to 16 weeks	Time from treatment to remission and the frequency of patients reaching remission on treatment

Secondary Outcome Measures

Name	Time	Method
Relapse	4 weeks to 1 year after remission	Frequency of relapse
Concentration of Prednisolone in saliva	4 weeks after initiating prednisolone treatment	Measurement of prednisolone metabolism by saliva test and genetic analysis of specific liver enzymes
Side effects to treatment	4 weeks to 1 year after remission	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.
Rates of genetic polymorphism, including HLA variations	Blood test at baseline	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.

Trial Locations

Locations (2)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Regional Hospital Viborg; 🇩🇰 Viborg, Denmark