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Certoparin in Renal Patients Undergoing Hemodialysis (MEMBRANE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01179620
Recruitment Status : Completed
First Posted : August 11, 2010
Last Update Posted : July 10, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis

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

Condition or disease Intervention/treatment Phase
Renal Dialysis Drug: Certoparin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2010
Primary Completion Date : March 2011
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Certoparin Drug: Certoparin
Certoparin



Primary Outcome Measures :
  1. Number of patients requiring uptitration [ Time Frame: Week 8 ]

Secondary Outcome Measures :
  1. Pharmacokinetics of Certoparin [ Time Frame: Day 1, Week 4 ]
  2. Safety and tolerability of Certoparin [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 11, 2010    Key Record Dates
Last Update Posted: July 10, 2012
Last Verified: July 2012

Keywords provided by Novartis:
Hemodialysis, Certoparin

Additional relevant MeSH terms:
Certoparin
Heparin, Low-Molecular-Weight
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action