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Completed

NCT Number: NCT03210688

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

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.

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Key information

Conditions

Minimal Change Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrosis Nephrosis, Lipoid Nephrotic Syndrome Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aarhus University Hospital, Aarhus, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prednisolone

Drug

Tablet prednisolone

Other names: Prednisone

Alfacalcidol

Drug

Capsule alfacalcidol 0,5 microgram/day

Primary outcomes

  1. Remission

    Time frame: 4 to 16 weeks

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

Secondary outcomes

  1. Relapse

    Time frame: 4 weeks to 1 year after remission

    Frequency of relapse

  2. Side effects to treatment

    Time frame: 4 weeks to 1 year after remission

    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.

  3. Concentration of Prednisolone in saliva

    Time frame: 4 weeks after initiating prednisolone treatment

    Measurement of prednisolone metabolism by saliva test and genetic analysis of specific liver enzymes

  4. Rates of genetic polymorphism, including HLA variations

    Time frame: Blood test at baseline

    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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Acronym: ADAPTinMCN

Important dates

Study start
2018
Primary completion
2024
Study completion
2025
First posted
Jul 7, 2017
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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