NCT03210688

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2018

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 7, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2025

Completed
Last Updated

January 24, 2025

Status Verified

January 1, 2025

Enrollment Period

5.8 years

First QC Date

July 3, 2017

Last Update Submit

January 21, 2025

Conditions

Minimal Change DiseaseNephrotic Syndrome

Keywords

PrednisolonealfacalcidolMinimal change nephropathy

Outcome Measures

Primary Outcomes (1)

  • Remission

    Time from treatment to remission and the frequency of patients reaching remission on treatment

    4 to 16 weeks

Secondary Outcomes (4)

  • Relapse

    4 weeks to 1 year after remission

  • Side effects to treatment

    4 weeks to 1 year after remission

  • Concentration of Prednisolone in saliva

    4 weeks after initiating prednisolone treatment

  • Rates of genetic polymorphism, including HLA variations

    Blood test at baseline

Study Arms (2)

High dose prednisolone

ACTIVE COMPARATOR

Prednisolone 1 mg/kg/day

Drug: Prednisolone

Alfacalcidol and low dose prednisolone

EXPERIMENTAL

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

Drug: PrednisoloneDrug: Alfacalcidol

Interventions

PrednisoloneDRUG

Tablet prednisolone

Also known as: Prednisone
Alfacalcidol and low dose prednisoloneHigh dose prednisolone
AlfacalcidolDRUG

Capsule alfacalcidol 0,5 microgram/day

Alfacalcidol and low dose prednisolone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aarhus University Hospital

Aarhus, Denmark

Location

Regional Hospital Viborg

Viborg, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 35230699DERIVED

  • 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.

    PMID: 34247632DERIVED

MeSH Terms

Conditions

Nephrosis, LipoidNephrotic Syndrome

Interventions

PrednisolonePrednisonealfacalcidol

Condition Hierarchy (Ancestors)

NephrosisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPregnadienediols

Study Officials

  • Per Ivarsen

    Aarhus University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2017

First Posted

July 7, 2017

Study Start

May 1, 2018

Primary Completion

February 14, 2024

Study Completion

January 21, 2025

Last Updated

January 24, 2025

Record last verified: 2025-01

Locations

DK(2)