E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Idiopathic Membranous Glomerulonephritis |
|
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 | 10029167 |
E.1.2 | Term | Nephrotic syndrome with lesion of membranous glomerulonephritis |
|
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 |
To investigate if the addition of mycophenylate mofetil to standard therapy with tacrolimus prevents relapse of nephrotic syndrome in patients with idiopathic membranous glomerulonephritis |
|
E.2.2 | Secondary objectives of the trial |
To investigate if the addition of mycophenylate mofetil to standard therapy with tacrolimus is more effective at decreasing proteinuria and maintaining renal function. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Idiopathic membranous glomerulonephritis on renal biopsy Heavy proteinuria- protein/creatinine ratio (PCR) >100 units with hypoalbuminaemia, or PCR >300 units with normal serum albumin -despite 3 months treatment with maximum tolerated doses of ACE inhibitors and angiotensin 2 antagonists. Male or female patients age 18-80 years. |
|
E.4 | Principal exclusion criteria |
Hepatits B, hepatitis C or HIV positive Malignancy Untreated infection Females who are pregnant, or breastfeeding, or at risk of pregnancy and not using adequate contraception. Any condition judged by the investigator that would cause the study to be detrimental to the patient. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Prevention of relapse of proteinuria on withdrawal of tacrolimus therapy, (all patients followed for at least 6 months post cessation of tacrolimus). |
|
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 | No |
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) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
standard treatment with tacrolimus alone |
|
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | Yes |
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
|
Primary endpoint will be the prevention of relapse 6 months post cessation of tacrolimus therapy. This will be measured 6 months after the last patient has stopped tacrolimus therapy. Secondary endpoints will be the time to obtaining remission from proteinuria, the degree of remission of proteinuria obtained (complete or partial), and the rate of decline of renal function measured by the MDRD equation for glomerular filtration rate. |
|
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 | |