Minimal Change Disease, Nephrotic Syndrome
Conditions
Keywords
Prednisolone, alfacalcidol, Minimal change nephropathy
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.
Interventions
DRUGPrednisolone
Tablet prednisolone
DRUGAlfacalcidol
Capsule alfacalcidol 0,5 microgram/day
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Remission | 4 to 16 weeks | Time from treatment to remission and the frequency of patients reaching remission on treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relapse | 4 weeks to 1 year after remission | Frequency of relapse |
| 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. |
| 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 |
| 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. |
Countries
Denmark
Outcome results
None listed