Minimal Change DiseasePhase 4ADAPTinMCNNCT03210688
Active Vitamin D And Reduced Dose Prednisolone for Treatment in Minimal Change Nephropathy
A Phase 4 study testing Prednisolone and Alfacalcidol in people with Minimal Change Disease and Nephrotic Syndrome, run by University of Aarhus at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Minimal Change Disease, Nephrotic Syndrome
- What is being tested?
- Prednisolone and Alfacalcidol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 May 2018to 21 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aarhus University Hospital
Aarhus
Regional Hospital Viborg
Viborg
About this study
Official title: Treatment of Primary Minimal Change Nephropathy: A Randomized Open-labeled Non-inferiority Study on Prednisolone and Vitamin D
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.
- Conditions
- Minimal Change Disease, Nephrotic Syndrome
- Being tested
- Prednisolone, Alfacalcidol
- Keywords
- Prednisolone, alfacalcidol, Minimal change nephropathy
- Medical subject headings
- Nephrosis, Lipoid, Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
Also called Prednisone
Tablet prednisolone
AlfacalcidolDrug
Capsule alfacalcidol 0,5 microgram/day
| Study group | Role | What they receive |
|---|---|---|
| High dose prednisolone | Active comparator | Prednisolone 1 mg/kg/day Receives: Drug: Prednisolone |
| Alfacalcidol and low dose prednisolone | Experimental | Alfacalcidol 0,5 microgram/day and Prednisolone 0,5 mg/kg/day Receives: Drug: Prednisolone; Drug: Alfacalcidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission
Time from treatment to remission and the frequency of patients reaching remission on treatment
Measured: 4 to 16 weeks
Secondary outcomes (4)
Relapse
Frequency of relapse
Measured: 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.
Measured: 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
Measured: 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.
Measured: Blood test at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start1 May 2018
- Primary completion14 Feb 2024
- Study completion21 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Minimal Change DiseaseStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Per Ivarsen, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210688
- Sponsor's protocol ID
- ADAPT in MCN
- Acronym
- ADAPTinMCN
- Status last verified
- Jan 2025
- First submitted
- 3 Jul 2017
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41905593Azukaitis 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.
PubMed 35230699Kristensen 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.
PubMed 34247632
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Primary Minimal Change Nephropathy: A Randomized Open-labeled Non-inferiority Study on Prednisolone and Vitamin D
- ClinicalTrials.gov ID
- NCT03210688
- Acronym / sponsor ID
- ADAPTinMCN / ADAPT in MCN
- Conditions
- Minimal Change Disease, Nephrotic Syndrome
- Keywords
- Prednisolone, alfacalcidol, Minimal change nephropathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 14 Feb 2024 (actual)
- Study completion
- 21 Jan 2025 (actual)
- First posted
- 7 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose prednisolone | Active comparator | Drug: PrednisolonePrednisolone 1 mg/kg/day |
| Alfacalcidol and low dose prednisolone | Experimental | Drug: Prednisolone, Drug: AlfacalcidolAlfacalcidol 0,5 microgram/day and Prednisolone 0,5 mg/kg/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Cancer except from basal cells carcinoma
- Lymphoproliferative disease
- Pregnancy
- eGFR < 30 ml/min/1,73m2 (CKD-EPI)
- Allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrednisoloneAlso: PrednisoneTablet prednisolone | Drug | Alfacalcidol and low dose prednisolone, High dose prednisolone |
| AlfacalcidolCapsule alfacalcidol 0,5 microgram/day | Drug | Alfacalcidol and low dose prednisolone |
Primary outcome
Remission
Time frame: 4 to 16 weeks
Time from treatment to remission and the frequency of patients reaching remission on treatment
4 secondary outcomes
Relapse
Time frame: 4 weeks to 1 year after remission
Side effects to treatment
Time frame: 4 weeks to 1 year after remission
Concentration of Prednisolone in saliva
Time frame: 4 weeks after initiating prednisolone treatment
Rates of genetic polymorphism, including HLA variations
Time frame: Blood test at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Derived from this study: PubMed 41905593Kristensen 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.
- Derived from this study: PubMed 35230699Azukaitis 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.
- Derived from this study: PubMed 34247632Kristensen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Ivarsen study chair
Aarhus University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisolone and Alfacalcidol in people with Minimal Change Disease and Nephrotic Syndrome, run by University of Aarhus at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission (time frame: 4 to 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03210688, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.