Certoparin in Renal Patients Undergoing Hemodialysis

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01179620

Acronym

MEMBRANE

Enrollment

109

Registered

2010-08-11

Start date

2010-11-30

Completion date

2011-03-31

Last updated

2012-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Dialysis

Keywords

Hemodialysis, Certoparin

Brief summary

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

Interventions

DRUGCertoparin

Certoparin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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/

Design outcomes

Primary

Measure	Time frame
Number of patients requiring uptitration	Week 8

Secondary

Measure	Time frame
Pharmacokinetics of Certoparin	Day 1, Week 4
Safety and tolerability of Certoparin	8 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026