Certoparin in Renal Patients Undergoing Hemodialysis (MEMBRANE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01179620
First received: July 27, 2010
Last updated: July 9, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention Phase
Renal Dialysis
Drug: Certoparin
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Number of patients requiring uptitration [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetics of Certoparin [ Time Frame: Day 1, Week 4 ] [ Designated as safety issue: No ]
  • Safety and tolerability of Certoparin [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 109
Study Start Date: November 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Certoparin Drug: Certoparin
Certoparin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01179620

Locations
Germany
Novartis Investigative Site Darmstadt
Darmstadt,, Germany
Novartis Investigative Site Elsenfeld
Elsenfeld, Germany
Novartis Investigative Site Flensburg
Flensburg, Germany
Novartis Investigative Site Heringen
Heringen, Germany
Novartis Investigative Site Hoyerswerda,
Hoyerswerda, Germany
Novartis Investigative Site Kronach
Kronach, Germany
Novartis Investigative Site Magdeburg
Magdeburg, Germany
Novartis Investigative Site München
München, Germany
Novartis Investigative Site Münster
Münster, Germany
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01179620     History of Changes
Other Study ID Numbers: CMEX839BDE06
Study First Received: July 27, 2010
Last Updated: July 9, 2012
Health Authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte

Keywords provided by Novartis:
Hemodialysis, Certoparin

Additional relevant MeSH terms:
Certoparin
Heparin, Low-Molecular-Weight
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 17, 2014