A Phase 4 interventional study of Prednisolone and Alfacalcidol in Minimal Change Disease and Nephrotic Syndrome, sponsored by University of Aarhus. Completed at 2 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-24.
Sponsored by University of Aarhus · Phase 4, Interventional, and Treatment
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.
75 studies on the registry are indexed under Nephrosis, Lipoid; 32 are open to participants now.
This study's enrollment of 71 is above the median of 49 across 46 interventional studies indexed under Nephrosis, Lipoid.
Browse Nephrosis, Lipoid studies →University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Prednisolone 1 mg/kg/day
Drug: Prednisolone
Alfacalcidol 0,5 microgram/day and Prednisolone 0,5 mg/kg/day
Drug: Prednisolone · Drug: Alfacalcidol
Tablet prednisolone
Also known as: Prednisone
Capsule alfacalcidol 0,5 microgram/day
Remission
Time from treatment to remission and the frequency of patients reaching remission on treatment
Time frame: 4 to 16 weeks
Relapse
Frequency of relapse
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Blood test at baseline
Plan to share: Undecided
Ran from May 2018 to primary completion in Feb 2024, 69 months.
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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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