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OpenTrials
Completed

NCT Number: NCT01179620

Certoparin in Renal Patients Undergoing Hemodialysis

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

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Key information

Conditions

Renal Dialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site Darmstadt, Darmstadt, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Certoparin

Drug

Certoparin

Primary outcomes

  1. Number of patients requiring uptitration

    Time frame: Week 8

Secondary outcomes

  1. Pharmacokinetics of Certoparin

    Time frame: Day 1, Week 4

  2. Safety and tolerability of Certoparin

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Acronym: MEMBRANE

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 11, 2010
Registry last updated
Jul 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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