E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
progressive IgA-Nephritis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029143 |
E.1.2 | Term | Nephritis-glomerular |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- frequency reduction of spontaneous GFR-loss from 20% or more |
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E.2.2 | Secondary objectives of the trial |
- progress of proteinuria - occurence of complications such as diabetes mellitus; frequency and severity of complications and treatment adverse effects - need for hospitalization - need for further hypertension medication - occurence of infections or malignancy |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age > 18 years and < 65 years, - gender: male and female - mesangioproliferative IgA nephritis, histological confirmed - < 30% of the glomeruli with extracapillary semilunars - Progressive form of IgA-Nephritis before start of the clinical trial - With formely normal renal function: Creatinine increase of > 25% or GFR loss of >20% over at least 1-2 years after diagnosis - With formerly impaired renal function: Creatinine>130 µmol/l and GFR <60 ml/min respectively: ongiong continous GFR loss within 5 months - MDRD-2 GFR < 60ml/min and Creatinine > 130 µmol/ after induction therapy respectively - Henoch-Schönlein purpura with IgA nephritis if ongoing progression after 12 months - Completed induction therapy - Proteinuria-creatinine ratio > 3.5 - Nephrotic syndrome after induction therapy - Supportive therapy with ACEi (at least 10 mg Enalapril or equivalent) or/and ARB (at least 300 mg Irbesartan or equivalent) and comparable anti-hypertensive drugs if hypertensivity - female patients with childbearing potential: negative urine pregnancy test before the start of the clinical trial and one of the following, medically accepted contraceptive methods during the whole clinical trial and at least 6 weeks after the last medication intake: surgical sterility, double barrier methods, intrauterine contraceptive device, lifestyle with a personal choice of abstinence, vasectomy of sexual partner at least 3 months prior to enrolment in combination with barrier methods or must be at least two years postmenopausal.
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E.4 | Principal exclusion criteria |
- Secondary IgA nephritis (such as lupus nephritis, liver cirrhoses) - Extracapillary proliferative Nephritis in > 30% of the glomerula - GFR>60ml/min after induction therapy (Creatinine <130 µmol/l) - Creatinine > 400 µmol/l after induction therapy in the majority of at least 3 measurements - Systolic blood pressure >140 mmHg in the majority of at least 3 measurements - Missing informed consent - Other exclusion criteria such as malignant tumor, pregnancy or significant co-morbiditiy according to the waiting list for renal transplant - Hypersensitivity to Mycophenolate sodium, Mycophenolic acid or Mycophenolate mofetil or any other compound of Myfortic® (see SmPC appendix 15.5.) - Any of the following medications: - Bile acid binding drugs or therapies, cholestyramine, orally given activated charcoal - Any drugs containing magnesium - Ganciclovir, Aciclovir (without medical supervision) - Vitamin D or ist derivatives, except for Decostriol® - 8 weeks prior vaccination or 2 weeks after vaccination - Active viral infection - HBsAG positive chronic active hepaitis - Lymphadenitis after BCG vaccination - Hypersensivity to Prednisolon (Decortin H®) or to any of the other components of Decortin H® - Hereditary fructose intolerance, hypoxanthine guanine phosphoribosyltransferase deficiency, galactose intolerance, lactase deficiency, glucose-galactose malabsorption
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E.5 End points |
E.5.1 | Primary end point(s) |
The main objective of this clinical trial is to investigate if the immunosuppressive therapy influences disease progression in patients with progredient Ig-A and whether the sequential immunosuppressive treatment with Mycophenolat combined with low dose Prednisolon in addition to the supportive therapy (ACEis and/or ARBs) is more effective in stopping a further GFR loss than the stand alone supportive therapy (ACEis und/ oder ARBs).
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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 | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
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.8.3 |
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 | 10 |
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 | Information not present in EudraCT |
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 | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |