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

NCT03210688 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2025-01-24

No results posted yet for this study

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.

Conditions

  • Minimal Change Disease
  • Nephrotic Syndrome

Interventions

DRUG

Prednisolone

Tablet prednisolone

DRUG

Alfacalcidol

Capsule alfacalcidol 0,5 microgram/day

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Per Ivarsen · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2024-02-14
Completion
2025-01-21

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03210688 on ClinicalTrials.gov