Certoparin in Renal Patients Undergoing Hemodialysis (MEMBRANE)

Novartis

Status and phase: Completed; Phase 3

Conditions: Renal Dialysis

Treatments: Drug: Certoparin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01179620

CMEX839BDE06

Details and patient eligibility

About

This study will assess the efficacy, safety and pharmacokinetics of certoparin when used to prevent clotting during hemodialysis.

Enrollment: 109 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

109 participants in 1 patient group

Certoparin

Experimental group

Treatment:

Drug: Certoparin