Treatment og primary minimal change nephropathy with prednisolone and vitamin D

Treatment of primary minimal change nephropathy. A randomized, open-labeled, non-inferiotiry study on prednisolone and vitamin D

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001206-16-DK

Enrollment

Registered

2017-05-05

Start date

2017-09-15

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Minimal Change Nephropathy MedDRA version: 21.1 Level: LLT Classification code 10027643 Term: Minimal change glomerulonephritis System Organ Class: 100000004857 MedDRA version: 21.1 Level: LLT Classification code 10058326 Term: Minimal change disease System Organ Class: 100000004857

Interventions

Trade Name: Prednisolone Pharmaceutical Form: Tablet Trade Name: Alfacalcidol Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Biopsi proven minimal change nephropathy If earlyer minimal change: No relaps in 5 years, and earlier only treated with prednisolone Nephrotic syndrome Age more than 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 26

Exclusion criteria

Exclusion criteria: Cancer exceps from basal celle carcinoma Lymphoproliferative disease Pregnacy eGFR < 30 ml/min/1,73m2 (CKD-EPI) Allergy No danish language No ability to give informed prove

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective is to se if lowers dose of prednisolone combined with vitamin D can give the same results in clearing the disease, but give the patients fewer side effects. We compare high dose prednisolone to low dose prednisolone cmbined with vitamin D, and we predict that the regimens are non-inferior and give the same results on the disease, but fewer side effects when prednisolone are reduced.;Secondary Objective: Better understanding of the patogenesis of the disease by analysing blood and urine test.;Primary end point(s): The frequency of remission after 16 weeks treatment and the time to remission;Timepoint(s) of evaluation of this end point: 16 weeks after randomizing to treatment	—

Measure

Time frame

Main Objective: The main objective is to se if lowers dose of prednisolone combined with vitamin D can give the same results in clearing the disease, but give the patients fewer side effects. We compare high dose prednisolone to low dose prednisolone cmbined with vitamin D, and we predict that the regimens are non-inferior and give the same results on the disease, but fewer side effects when prednisolone are reduced.;Secondary Objective: Better understanding of the patogenesis of the disease by analysing blood and urine test.;Primary end point(s): The frequency of remission after 16 weeks treatment and the time to remission;Timepoint(s) of evaluation of this end point: 16 weeks after randomizing to treatment

—

Secondary

Measure	Time frame
Secondary end point(s): The frequency of relaps 1 year after remission on treatment Time to relaps Amount of and differences in side effects Admission to hospital (cause, frequency, duration);Timepoint(s) of evaluation of this end point: one year after remission	—

Countries

Denmark

Contacts

Public ContactPer Ivarsen

Nyresygdomme, Aarhus University hospital

perivars@rm.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 14, 2026