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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose prednisolone | Active Comparator | Prednisolone 1 mg/kg/day |
|
| Alfacalcidol and low dose prednisolone | Experimental | Alfacalcidol 0,5 microgram/day and Prednisolone 0,5 mg/kg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisolone | Drug | Tablet prednisolone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Remission | Time from treatment to remission and the frequency of patients reaching remission on treatment | 4 to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse | Frequency of relapse | 4 weeks to 1 year after remission |
| Side effects to treatment | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Per Ivarsen | Aarhus University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | Denmark | ||||
| Regional Hospital Viborg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41905593 | Derived | Kristensen T, Tougaard B, Thuesen AD, Peters CD, Hansen D, Rydahl C, Borg R, Lyngso C, Mose FH, Bech J, Gramkow AM, Gregersen JW, Pedersen BB, Resuli M, Birn H, Ivarsen P. A randomized controlled non-inferiority trial examined lower dose prednisolone and activated vitamin D in adult minimal change podocytopathy. Kidney Int. 2026 Jun;109(6):1308-1317. doi: 10.1016/j.kint.2026.02.035. Epub 2026 Mar 27. | |
| 35230699 |
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| ID | Term |
|---|---|
| D009402 | Nephrosis, Lipoid |
| D009404 | Nephrotic Syndrome |
| ID | Term |
|---|---|
| D009401 | Nephrosis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011241 | Prednisone |
| C008088 | alfacalcidol |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Alfacalcidol | Drug | Capsule alfacalcidol 0,5 microgram/day |
|
| 4 weeks to 1 year after remission |
| Concentration of Prednisolone in saliva | Measurement of prednisolone metabolism by saliva test and genetic analysis of specific liver enzymes | 4 weeks after initiating prednisolone treatment |
| Rates of genetic polymorphism, including HLA variations | 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. | Blood test at baseline |
| Viborg |
| Denmark |
| Derived |
| 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. |
| 34247632 | Derived | 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. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011244 | Pregnadienediols |