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

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ClinicalTrials.gov Identifier: NCT03210688
Recruitment Status : Recruiting
First Posted : July 7, 2017
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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
Minimal Change Disease Nephrotic Syndrome Drug: Prednisolone Drug: Alfacalcidol Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022


Arm Intervention/treatment
Active Comparator: High dose prednisolone
Prednisolone 1 mg/kg/day
Drug: Prednisolone
Tablet prednisolone
Other Name: Prednisone

Experimental: Alfacalcidol and low dose prednisolone
Alfacalcidol 0,5 microgram/day and Prednisolone 0,5 mg/kg/day
Drug: Prednisolone
Tablet prednisolone
Other Name: Prednisone

Drug: Alfacalcidol
Capsule alfacalcidol 0,5 microgram/day




Primary Outcome Measures :
  1. Remission [ Time Frame: 4 to 16 weeks ]
    Time from treatment to remission and the frequency of patients reaching remission on treatment


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210688


Contacts
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Contact: Tilde Kristensen, MD tilde.kristensen@rm.dk
Contact: Per Ivarsen +45 40460063 perivars@rm.dk

Locations
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Denmark
Aarhus University Hospital Recruiting
Aarhus, Denmark
Contact: Per Ivarsen         
Regional Hospital Viborg Recruiting
Viborg, Denmark
Contact: Tilde Kristensen         
Principal Investigator: Tilde Kristensen         
Sponsors and Collaborators
University of Aarhus
Investigators
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Study Chair: Per Ivarsen Aarhus University Hospital
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03210688    
Other Study ID Numbers: ADAPT in MCN
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Kidney Diseases
Nephrotic Syndrome
Nephrosis
Nephrosis, Lipoid
Urologic Diseases
Alfacalcidol
Hydroxycholecalciferols
Prednisone
Prednisolone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Bone Density Conservation Agents
Vitamins
Micronutrients
Nutrients
Growth Substances