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

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus
• Treatments: Alfacalcidol; Hydroxycholecalciferols; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone; Vitamin D

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