NCT01179620CompletedPhase 3
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
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novartis
- Enrollment
- 109
- Locations
- 9
- Primary Endpoint
- Number of patients requiring uptitration
Study Overview
Brief Summary
This study will assess the efficacy, safety and pharmacokinetics of certoparin when used to prevent clotting during hemodialysis.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients requiring hemodialysis
- •Patients requiring anticoagulation therapy during hemodialysis
- •Written informed consent
Exclusion Criteria
- •Hypersensitivity to study medication
- •Genetic abnormality or disease of clotting system
- •Prior major surgery or bleeding
- •Other protocol-defined inclusion/exclusion criteria may apply
Arms & Interventions
Certoparin
Experimental
Intervention: Certoparin (Drug)
Outcomes
Primary Outcomes
Number of patients requiring uptitration
Time Frame: Week 8
Secondary Outcomes
- Pharmacokinetics of Certoparin(Day 1, Week 4)
- Safety and tolerability of Certoparin(8 weeks)
Investigators
Study Sites (9)
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