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

Nephrotic Syndrome Clinical Trial

— ADAPTinMCN  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03210688
• Other study ID #: ADAPT in MCN
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: May 1, 2018
• Est. completion date: May 31, 2025

Study information

• Verified date: September 2023
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 71
• Est. completion date: May 31, 2025
• Est. primary completion date: February 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases
• Minimal Change Disease
• Nephrosis
• Nephrosis, Lipoid
• Nephrotic Syndrome

Intervention

Drug:
• Prednisolone
Tablet prednisolone
• Alfacalcidol
Capsule alfacalcidol 0,5 microgram/day

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
Denmark	Regional Hospital Viborg	Viborg

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission	Time from treatment to remission and the frequency of patients reaching remission on treatment	4 to 16 weeks
Secondary	Relapse	Frequency of relapse	4 weeks to 1 year after remission
Secondary	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.	4 weeks to 1 year after remission
Secondary	Concentration of Prednisolone in saliva	Measurement of prednisolone metabolism by saliva test and genetic analysis of specific liver enzymes	4 weeks after initiating prednisolone treatment
Secondary	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.	Blood test at baseline