E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic glomerulonephritis, a chronic inflammatory process of the kidney, represents an important cause of end stage renal disease that requires long-term hemodialysis (or renal transplantation). Until now, no specific therapy of chronic glomerulonephritis has been established. Therefore, novel therapeutic approaches are urgently needed, that can at least inhibit progression of disease and can prevent (or delay) end stage renal disease. |
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MedDRA Classification |
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 |
The objective of this study is to show, that treatment with low molecular weight heparin (Clexane®) will inhibit the chronic inflammatory process in patients with chronic glomerulonephritis (measured as reduction of proteinuria, primary endpoint). Furthermore, this study should answer the question whether treatment with Clexane® can inhibit progression of disease in patients with chronic glomerulonephritis (kidney function measured as Δ Cystatin-C-concentration and / or Δ GFR (glomerular filtration rate, calculated according to the MDRD formula)). |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
The following inclusion criteria must be fullfilled for inclusion into the study:
1. biopsy proven chronic glomerulonephritis 2. proteinuria > 1g/d 3. GFR > 30ml/min (according to MDRD formula)
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E.4 | Principal exclusion criteria |
1. Contraindications to the use of anticoagulants, such as uncontrolled hypertension, gastro-intestinal ulcers, erosive gastritis, surgery on eyes, CNS or ear within the last 6 months, cerebral hemorrhagic disorder within the last 6 months etc. 2. Thrombocytopenia <100 G/l 3. Heparin-induced thrombocytopenia (HIT, type II) 4. Coagulopathies 5. Need for anticoagulation with other medications such as warfarin 6. Severe liver dysfunction 7. Malignant tumors 8. Chronic inflammatory bowl disease 9. Diabetes mellitus 10. Wegener’s disease 11. Lupus erythematosus 11. Lupus erythematosus 12. Urolithiasis 13. Severe psychiatric disorders 14. Immunosuppressive therapy 15. Pregnancy
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint: reduction of proteinuria
Secondary endpoints (kidney function): measured as Δ Cystatin-C-concentration (serum) and / or Δ GFR (calculated according to the MDRD formula).
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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 | 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 | 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) | 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 | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 trial will be finished for the individual patient after 13 months |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |