MEMBRANE: Certoparin in Renal Patients Undergoing Hemodialysis

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01179620
• Collaborator: (none)
• Enrollment: 109
• Locations: 9
• Arm: 1
• Duration (Months): 3.9
• Patients Per Site: 12.1
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 109 participants
• Allocation: N/A
• 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: Nov 1, 2010
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Certoparin	Drug: Certoparin; Certoparin

Outcome Measures

Primary Outcome Measures

1. Number of patients requiring uptitration [Week 8]

Secondary Outcome Measures

1. Pharmacokinetics of Certoparin [Day 1, Week 4]

2. Safety and tolerability of Certoparin [8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site Darmstadt	Darmstadt,		Germany
2	Novartis Investigative Site Elsenfeld	Elsenfeld		Germany
3	Novartis Investigative Site Flensburg	Flensburg		Germany
4	Novartis Investigative Site Heringen	Heringen		Germany
5	Novartis Investigative Site Hoyerswerda,	Hoyerswerda		Germany
6	Novartis Investigative Site Kronach	Kronach		Germany
7	Novartis Investigative Site Magdeburg	Magdeburg		Germany
8	Novartis Investigative Site München	München		Germany
9	Novartis Investigative Site Münster	Münster		Germany

Sponsors and Collaborators

• Novartis

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT01179620
• Other Study ID Numbers: CMEX839BDE06
• First Posted: Aug 11, 2010
• Last Update Posted: Jul 10, 2012
• Last Verified: Jul 1, 2012

• Keywords provided by Novartis: Hemodialysis, Certoparin
• Additional relevant MeSH terms: Certoparin

Study Results

No Results Posted as of Jul 10, 2012