NCT01179620

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2010

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 11, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

July 10, 2012

Status Verified

July 1, 2012

Enrollment Period

4 months

First QC Date

July 27, 2010

Last Update Submit

July 9, 2012

Conditions

Renal Dialysis

Keywords

Hemodialysis, Certoparin

Outcome Measures

Primary Outcomes (1)

  • Number of patients requiring uptitration

    Week 8

Secondary Outcomes (2)

  • Pharmacokinetics of Certoparin

    Day 1, Week 4

  • Safety and tolerability of Certoparin

    8 weeks

Study Arms (1)

Certoparin

EXPERIMENTAL
Drug: Certoparin

Interventions

CertoparinDRUG

Certoparin

Certoparin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Hypersensitivity to study medication
  • Genetic abnormality or disease of clotting system
  • Prior major surgery or bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Novartis Investigative Site Darmstadt

Darmstadt, Germany

Location

Novartis Investigative Site Elsenfeld

Elsenfeld, Germany

Location

Novartis Investigative Site Flensburg

Flensburg, Germany

Location

Novartis Investigative Site Heringen

Heringen, Germany

Location

Novartis Investigative Site Hoyerswerda,

Hoyerswerda, Germany

Location

Novartis Investigative Site Kronach

Kronach, Germany

Location

Novartis Investigative Site Magdeburg

Magdeburg, Germany

Location

Novartis Investigative Site München

München, Germany

Location

Novartis Investigative Site Münster

Münster, Germany

Location

Related Publications (1)

  • 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.

    PMID: 22742742DERIVED

MeSH Terms

Interventions

certoparin

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2010

First Posted

August 11, 2010

Study Start

November 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

July 10, 2012

Record last verified: 2012-07

Locations

DE(9)