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CompletedNCT01179620MEMBRANEUpdated Jul 10, 2012

Certoparin in Renal Patients Undergoing Hemodialysis

A Phase 3 interventional study of Certoparin in Renal Dialysis, sponsored by Novartis. Completed at 9 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-07-10.

Sponsored by Novartis · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
109
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Renal Dialysis

Keywords

  • Hemodialysis, Certoparin
03

In context

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients requiring hemodialysis
  • Patients requiring anticoagulation therapy during hemodialysis
  • Written informed consent

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
109 participants (actual)

Study arms

  • Experimental
    Certoparin

    Drug: Certoparin

Interventions

  • DrugCertoparin

    Certoparin

06

What researchers measure

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

07

Study locations

9 sites
  • 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
08

References and documents

Publications

  • 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. PubMed 22742742 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01179620
Lead sponsor
Novartis
Responsible party
Sponsor
First posted
Aug 11, 2010
Start date
Nov 2010
Primary completion
Mar 2011
Completion
Mar 2011
Last update
Jul 10, 2012

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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