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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    96
  • sponsor
    University of Aarhus
Updated on 4 April 2021
remission
vitamin d
treatment regimen
prednisolone
nephropathy
active vitamin d
minimal change disease

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.

Details
Condition Nephrotic Syndrome, Nephrotic Syndrome, Lipoid nephrosis, minimal change disease
Treatment Prednisolone, Alfacalcidol
Clinical Study IdentifierNCT03210688
SponsorUniversity of Aarhus
Last Modified on4 April 2021

Eligibility

Yes No Not Sure

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
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