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

Sponsor
University of Aarhus (Other)
Overall Status
Recruiting
CT.gov ID
NCT03210688
Collaborator
(none)
96
Enrollment
2
Locations
2
Arms
92
Anticipated Duration (Months)
48
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
96 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treatment of Primary Minimal Change Nephropathy: A Randomized Open-labeled Non-inferiority Study on Prednisolone and Vitamin D
Actual Study Start Date :
May 1, 2018
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: High dose prednisolone

Prednisolone 1 mg/kg/day

Drug: Prednisolone
Tablet prednisolone
Other Names:
  • Prednisone

    		•
    Experimental: Alfacalcidol and low dose prednisolone

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

    Drug: Prednisolone
    Tablet prednisolone
    Other Names:
  • Prednisone

    • Drug: Alfacalcidol
    Capsule alfacalcidol 0,5 microgram/day

    Outcome Measures

    Primary Outcome Measures

    1. Remission [4 to 16 weeks]

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

    Secondary Outcome Measures

    1. Relapse [4 weeks to 1 year after remission]

      Frequency of relapse

    2. Side effects to treatment [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aarhus University Hospital Aarhus Denmark
    2 Regional Hospital Viborg Viborg Denmark

    Sponsors and Collaborators

    • University of Aarhus

    Investigators

    • Study Chair: Per Ivarsen, Aarhus University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Aarhus
    ClinicalTrials.gov Identifier:
    NCT03210688
    Other Study ID Numbers:
    • ADAPT in MCN
    First Posted:
    Jul 7, 2017
    Last Update Posted:
    May 20, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by University of Aarhus
    Prednisolone
    alfacalcidol
    Minimal change nephropathy
    Additional relevant MeSH terms:
    Kidney Diseases
    Nephrotic Syndrome
    Nephrosis
    Nephrosis, Lipoid
    Alfacalcidol
    Hydroxycholecalciferols
    Prednisone
    Prednisolone

    Study Results

    No Results Posted as of May 20, 2022