Active Vitamin D And Reduced Dose Prednisolone for Treatment in Minimal Change Nephropathy
NCT ID: NCT03210688
Last Updated: 2025-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
71 participants
INTERVENTIONAL
2018-05-01
2025-01-21
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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High dose prednisolone
Prednisolone 1 mg/kg/day
Prednisolone
Tablet prednisolone
Alfacalcidol and low dose prednisolone
Alfacalcidol 0,5 microgram/day and Prednisolone 0,5 mg/kg/day
Prednisolone
Tablet prednisolone
Alfacalcidol
Capsule alfacalcidol 0,5 microgram/day
Interventions
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Prednisolone
Tablet prednisolone
Alfacalcidol
Capsule alfacalcidol 0,5 microgram/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* If earlier minimal change: No relapse in 5 years, and earlier only treated with prednisolone
* Nephrotic syndrome
* Age more than 18 years
Exclusion Criteria
* Lymphoproliferative disease
* Pregnancy
* eGFR \< 30 ml/min/1,73m2 (CKD-EPI)
* Allergy
* No danish language
* No ability to give informed prove
18 Years
ALL
No
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Per Ivarsen
Role: STUDY_CHAIR
Aarhus University Hospital
Locations
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Aarhus University Hospital
Aarhus, , Denmark
Regional Hospital Viborg
Viborg, , Denmark
Countries
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References
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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.
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.
Other Identifiers
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ADAPT in MCN
Identifier Type: -
Identifier Source: org_study_id
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