patients undergoing chronic dialysis MedDRA version: 12.1 Level: LLT Classification code 10066622 Term: Chronic hemodialysis
Conditions
Interventions
Trade Name: Mono-Embolex 3000 I.E. Prophylaxe Sicherheitsspritze
Pharmaceutical Form: Solution for injection
CAS Number: 0
Other descriptive name: CERTOPARIN SODIUM
Concentration unit: IU internationa
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ambulatory patients =18 years, of either sex 2. Established end stage chronic kidney failure (CKF), requiring stable hemodialysis therapy (2-3 times per week) 3. Chronic hemodialysis therapy (including hemodiafiltration and hemofiltration) of at least 4h duration per session, for at least 3 months 4. Indication for anticoagulation during hemodialysis 5. Hemoglobin =10.0 g/dL at visit 1 6. Written informed consent given by the patient 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. Hypersensitivity/allergy to one of the components of the study drug (including chlorocresol) or to drugs with similar chemical structures 2. History of clinically significant bleeding within the last 4 weeks 3. Acute or chronic illness that can change the blood coagulation, or aggravate or terminate the clinical picture, such as peptic ulcer, active symptomatic diverticulitis, or cancer 4. Genetic abnormality of the clotting system (congenital bleeding disorder such as hemorrhagic diathesis, deficiency of coagulation factors, severe thrombocytopenia or otherwise increased bleeding risk) 5. Prior major surgery, trauma or invasive procedure of the central nervous system 6. Any prior major surgery, trauma or invasive procedure within the last 4 weeks 7. Acute or history of heparin induced thrombocytopenia type II (HIT II) 8. CRP > 300 mg/l 9. Acute severe infection (e.g. endocarditis, pneumonia, sepsis) 10. Target blood flow in device less than 200 ml/min. This holds for inclusion time point and during the study. 11. Patients using the following medicines: Dextran 40, chronic systemic glucocorticoids (= 4 months), thrombolytic agents and anticoagulants (e.g. phenprocoumon), glycoprotein IIb / IIIa antagonists. This holds for inclusion time point and during the study, see 6.7.5. 12. LMWH/heparin administration on three or more consecutiv days in the 5 days prior to inclusion 13. Immobilization due to cast or fracture 14. Life expectancy 30% per year) 15. Acute symptomatic DVT / PE 16. Acute or history of non-hemorrhagic stroke ( 105 mmHg 20. Severe liver disease 21. Retinopathy, intravitreal or other intraocular bleeding or eye/ear injury 22. Participation in another clinical trial within the last 30 days 23. Subjects unlikely to comply with the requirements of the protocol. 24. Woman who are pregnant or breast feeding (pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml)) o who are menstruating and capable of becoming pregnant* and not practicing a medically approved method of contraception (Pearl Index <1**) during and up to at least 4 weeks after the end of treatment. A negative pregnancy test (serum) for all women and for girls entering menarche is required with sufficient lead time before inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to investigate the efficacy of certoparin to prevent clotting in the extracorporeal circulation during hemodialysis at week 8. The primary endpoint is the percentage of unsatisfactory dialysis results at visit V4 (wwek 8) due to clotting or bleeding.;Secondary Objective: The secondary objectives are • to assess the pharmacokinetics of certoparin in subjects receiving regular hemodialysis treatments including hemodiafiltration and hemofiltration, indirectly determined by the concentration-time profile of antifactor Xa activity using a chromogenic assay. • to document the safety and tolerability of certoparin over 8 weeks in subjects receiving regular hemodialysis treatments • to assess clinical efficacy by inspection of the filter system (lines, bubble catcher, dialyzer) at the site of dialysis • to assess efficacy via the percentage of clotted area in the transversal (= horizontal) plane of the filter ;Primary end point(s): The primary endpoint is the nececcity to uptitrate the certoparin dose at week 8 due to clotting in the dialysis filter. | — |
Countries
Germany
Outcome results
None listed