Certoparin in Renal Patients Undergoing Hemodialysis

NCT ID: NCT01179620

Last Updated: 2012-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-03-31

Brief Summary

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

Detailed Description

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Conditions

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Renal Dialysis

Keywords

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Hemodialysis, Certoparin

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Certoparin

Group Type EXPERIMENTAL

Certoparin

Intervention Type DRUG

Certoparin

Interventions

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Certoparin

Certoparin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site Darmstadt

Darmstadt, , Germany

Site Status

Novartis Investigative Site Elsenfeld

Elsenfeld, , Germany

Site Status

Novartis Investigative Site Flensburg

Flensburg, , Germany

Site Status

Novartis Investigative Site Heringen

Heringen, , Germany

Site Status

Novartis Investigative Site Hoyerswerda,

Hoyerswerda, , Germany

Site Status

Novartis Investigative Site Kronach

Kronach, , Germany

Site Status

Novartis Investigative Site Magdeburg

Magdeburg, , Germany

Site Status

Novartis Investigative Site München

München, , Germany

Site Status

Novartis Investigative Site Münster

Münster, , Germany

Site Status

Countries

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Germany

References

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Dorsch O, Krieter DH, Lemke HD, Fischer S, Melzer N, Sieder C, Bramlage P, Harenberg J. A multi-center, prospective, open-label, 8-week study of certoparin for anticoagulation during maintenance hemodialysis--the membrane study. BMC Nephrol. 2012 Jun 28;13:50. doi: 10.1186/1471-2369-13-50.

Reference Type DERIVED
PMID: 22742742 (View on PubMed)

Other Identifiers

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CMEX839BDE06

Identifier Type: -

Identifier Source: org_study_id