Clinical trial NCT03210688: Active Vitamin D And Reduced Dose Prednisolone for Treatment in Minimal Change Nephropathy
Official title: Treatment of Primary Minimal Change Nephropathy: A Randomized Open-labeled Non-inferiority Study on Prednisolone and Vitamin D
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Minimal Change Disease
Nephrotic Syndrome
Keywords: Prednisolone
alfacalcidol
Minimal change nephropathy
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2017-07-07
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Remission
timeFrame: 4 to 16 weeks
Secondary outcomes:
measure: Relapse
timeFrame: 4 weeks to 1 year after remission
measure: Side effects to treatment
timeFrame: 4 weeks to 1 year after remission
measure: Concentration of Prednisolone in saliva
timeFrame: 4 weeks after initiating prednisolone treatment
measure: Rates of genetic polymorphism, including HLA variations
timeFrame: Blood test at baseline
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Viborg
country: Denmark
facility: Regional Hospital Viborg
Study officials:
affiliation: Aarhus University Hospital
name: Per Ivarsen
role: STUDY_CHAIR
References:
citation: Azukaitis K, Palmer SC, Strippoli GF, Hodson EM. Interventions for minimal change disease in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2022 Mar 1;3(3):CD001537. doi: 10.1002/14651858.CD001537.pub5.
citation: Kristensen T, Birn H, Ivarsen P. A randomised controlled unblinded multicentre non-inferiority trial with activated vitamin D and prednisolone treatment in patients with minimal change nephropathy (ADAPTinMCN). Trials. 2021 Jul 12;22(1):442. doi: 10.1186/s13063-021-05393-4.