Treatment og primary minimal change nephropathy with prednisolone and vitamin D

Phase 1

• Conditions: Minimal Change Nephropathy; MedDRA version: 21.1Level: LLTClassification code 10027643Term: Minimal change glomerulonephritisSystem Organ Class: 100000004857; MedDRA version: 21.1Level: LLTClassification code 10058326Term: Minimal change diseaseSystem Organ Class: 100000004857; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2017-001206-16-DK
• Lead Sponsor: Aarhus University hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-05
• Last Update Posted: 1 February 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Biopsi proven minimal change nephropathy
If earlyer minimal change: No relaps in 5 years, and earlier only treated with prednisolone
Nephrotic syndrome
Age more than 18 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26

Exclusion Criteria

Cancer exceps from basal celle carcinoma
Lymphoproliferative disease
Pregnacy
eGFR < 30 ml/min/1,73m2 (CKD-EPI)
Allergy
No danish language
No ability to give informed prove

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective is to se if lowers dose of prednisolone combined with vitamin D can give the same results in clearing the disease, but give the patients fewer side effects. <br>We compare high dose prednisolone to low dose prednisolone cmbined with vitamin D, and we predict that the regimens are non-inferior and give the same results on the disease, but fewer side effects when prednisolone are reduced.;Secondary Objective: Better understanding of the patogenesis of the disease by analysing blood and urine test.;Primary end point(s): The frequency of remission after 16 weeks treatment and the time to remission;Timepoint(s) of evaluation of this end point: 16 weeks after randomizing to treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The frequency of relaps 1 year after remission on treatment<br>Time to relaps<br>Amount of and differences in side effects<br>Admission to hospital (cause, frequency, duration);Timepoint(s) of evaluation of this end point: one year after remission