A multi-center, prospective, open-label, 8-weeks study to investigate the efficacy, safety and pharmacokinetics of certoparin (3000 IU anti-Xa bolus, with the option to titrate dose) in the prophylaxis of clotting in the extracorporeal circuit in patients undergoing chronic hemodialysis

• Conditions: patients undergoing chronic dialysis; MedDRA version: 12.1Level: LLTClassification code 10066622Term: Chronic hemodialysis

• Registration Number: EUCTR2010-019200-23-DE
• Lead Sponsor: ovartis Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-18
• Last Update Posted: 22 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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 < 6 months or illness with very high acute mortality (> 30% per year)
15.Acute symptomatic DVT / PE
16.Acute or history of non-hemorrhagic stroke (< 3 months); hemorrhagic stroke or intracranial bleeding (< 12 months) or stroke for which thrombolytic therapy is planned
17.Acute or ongoing intracranial disease, e.g. cerebral aneurysm
18.Spinal or epidural anesthesia, lumbar punction within the last 12 hours
19.Uncontrolled hypertension, defined as diastolic blood pressure > 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))
owho 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified