E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
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 aim of this study is to compare among patients suffering from membranous nephropathy therapy with cyclosporine A together with an angiotensin-converting enzyme inhibitor to an angiotensin-converting enzyme inhibitor alone on the proportion of patients achieving complete remission at the of month 6 (no proteinuria or proteinuria <0.5 gr/d).
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E.2.2 | Secondary objectives of the trial |
- Renal function assessed by serum creatinine and by calculated GFR at months 6,12 and 24 - Change in renal function versus baseline assessed at months 6,12 and 24 - Percent patients into complete remission at months 12 and 24 - Percent patients into partial remission at months 6, 12 and 24 - Percent patients with no remission at months 6, 12 and 24 - Percent patients where dialysis was required - Percent patients where serum creatinine values doubled - Blood pressure, percent of patients on hyotensive therapy, and N° of hypotensive drugs per patient at months 6, 12 and 24 - Total cholesterol, HDL- and LDL-cholesterol, triglycerides levels; percent of patients on hypolipemic therapy and type of drug administered (statins or fibrates) at months 6, 12 and 24.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1) Male and female patients aged from 18 to 70 years old. 2) Patients with initial (in order to exclude those with relapses, and to make the group more homogeneous) clinical diagnosis of de novo nephrotic syndrome (i.e. proteinuria > 3 g/d., hypoalbuminemia, hyperlipidemia) and biopsy proven membranous nephropathy. 3) Renal function > 50 ml/min. per 1.73 m² body surface area as measured by a 24 hrs. urine creatinine clearance. 4) Written informed consent should be obtained from participating patients 5) Females of childbearing age should use appropriate contraception.
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E.4 | Principal exclusion criteria |
1) Current malignancies or history of previous malignancies except for treated basal or squamous cell skin carcinoma. 2) Metabolic disorders (including diabetes mellitus patients) or systemic diseases (e.g. lupus,…) 3) Active liver diseases 4) Presence of another kidney disease 5) Disorders of the central nervous system 6) The use of immunosuppressive therapy 3 months prior to the start of the study 7) Kidney transplanted patients 8) Active infection at study entry 9) Known hypersensitivity to ACE-inhibitors or contraindication for ACE-inhibitors 10) Renal artery stenosis 11) Pregnancy or wish to become pregnant during the study period 12) Non-compliance or psychological disorders which may impair the compliance of the patient 13) HIV-positive patients
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E.5 End points |
E.5.1 | Primary end point(s) |
Percent patients into complete remission at the end of month 6 (no proteinuria or proteinuria <0.5 gr/d).
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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 | Information not present in EudraCT |
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 | No |
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) | No |
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.8.5 | 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 | Information not present in EudraCT |
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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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 | 60 |
E.8.9.1 | In the Member State concerned days | |