Certoparin in Renal Patients Undergoing Hemodialysis

Phase 3

Completed

• Conditions: Renal Dialysis
• Interventions: Drug: Certoparin

• Registration Number: NCT01179620
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-27
• Study First Submitted QC: 2010-08-10
• Study First Posted: 2010-08-11
• Study Start: 2010-11
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-09
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Certoparin	Certoparin	-

Primary Outcome Measures

Name	Time	Method
Number of patients requiring uptitration	Week 8

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of Certoparin	Day 1, Week 4
Safety and tolerability of Certoparin	8 weeks

Trial Locations

Locations (9)

Novartis Investigative Site Magdeburg; 🇩🇪 Magdeburg, Germany

Novartis Investigative Site Flensburg; 🇩🇪 Flensburg, Germany

Novartis Investigative Site Kronach; 🇩🇪 Kronach, Germany

Novartis Investigative Site Münster; 🇩🇪 Münster, Germany

Novartis Investigative Site Heringen; 🇩🇪 Heringen, Germany

Novartis Investigative Site Hoyerswerda,; 🇩🇪 Hoyerswerda, Germany

Novartis Investigative Site Darmstadt; 🇩🇪 Darmstadt,, Germany

Novartis Investigative Site Elsenfeld; 🇩🇪 Elsenfeld, Germany

Novartis Investigative Site München; 🇩🇪 München, Germany