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.
Conditions
Interventions
Trade Name: Clexane (40 mg)
Product Name: Clexane
Pharmaceutical Form: Injection*
INN or Proposed INN: Enoxaparin-Natrium
Concentration unit: mg milligram(s)
Concentration number: 40-
Sponsors
IIT : University Hospital - Medical Clinic II (Director: Prof. Dr. med. J. Floege - Sponsor)
Eligibility
Sex/Gender
All
Inclusion criteria
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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 ? Cystatin-C-concentration and / or ? GFR (glomerular filtration rate, calculated according to the MDRD formula)).;Secondary Objective: ;Primary end point(s): Primary endpoint: reduction of proteinuria Secondary endpoints (kidney function): measured as ? Cystatin-C-concentration (serum) and / or ? GFR (calculated according to the MDRD formula). | — |
Countries
Germany
Outcome results
None listed