E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Minimal Change Nephropathy |
Minimal change nefropati |
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E.1.1.1 | Medical condition in easily understood language |
Minimal changes in the kidneys |
Minimale læsioner i nyrerne |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027643 |
E.1.2 | Term | Minimal change glomerulonephritis |
E.1.2 | System Organ Class | 100000004857 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10058326 |
E.1.2 | Term | Minimal change disease |
E.1.2 | System Organ Class | 100000004857 |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
Formålet med nærværende studie er at undersøge i et kontrolleret, randomiseret design, om der ved anvendelse af lavere, kumulerede prednisolon dosis med tilskud af aktiv vitamin D (alfacalcidol) kan opnås samme grad af remission og risiko for relaps ved MCN som ved behandling med standard prednisolon-behandling, jfr. eksisterende guidelines samt, om reduktion af prednisolondosis medfører færre bivirkninger sammenlignet med standardbehandling. |
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E.2.2 | Secondary objectives of the trial |
Better understanding of the patogenesis of the disease by analysing blood and urine test. |
Bedre forståelse af sygdommen via analyse af diverse blod og urinprøver. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
Biopsi verificeret MCN Hvis tidligere MCN: Recidivfri gennem mindst 5 år og kun tidligere behandlet med prednisolon. Nefrotisk syndrom ved debut Alder> 18år
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E.4 | Principal 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 |
Sekundær MCN Aktiv cancersygdom, bortset fra basal celle carcinom Lymfoproliferativ sygdom Graviditet eGFR < 30 ml/min/1,73 m2 (CKD-EPI) Manglende evne til at afgive informeret samtykke Manglende dansk sprogkundskaber Allergi overfor indholdsstofferne i forsøgsmedicinen
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E.5 End points |
E.5.1 | Primary end point(s) |
The frequency of remission after 16 weeks treatment and the time to remission |
Hyppigheden af remission efter 16 uger og tid til remission |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
16 weeks after randomizing to treatment |
16 uger efter opstart af randomiseret behandling |
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E.5.2 | 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) |
Hyppigheden af relaps i 1 år efter remission Tid til evt. relaps Forskelle i bivirkninger ved behandling med standard og lav dosis prednisolon Hospitalsindlæggelser (årsag, frekvens, varighed)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
one year after remission |
1 år efter patienterne opnår remission i sygdommen |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |