Certoparin in Renal Patients Undergoing Hemodialysis

Renal Dialysis Clinical Trial

— MEMBRANE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01179620
• Other study ID #: CMEX839BDE06
• Status: Completed
• Phase: Phase 3
• First received: July 27, 2010
• Last updated: July 9, 2012
• Start date: November 2010
• Est. completion date: March 2011

Study information

• Verified date: July 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Renal Dialysis

Intervention

Drug:
• Certoparin
Certoparin

Locations

Country	Name	City	State
Germany	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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients requiring uptitration		Week 8	No
Secondary	Pharmacokinetics of Certoparin		Day 1, Week 4	No
Secondary	Safety and tolerability of Certoparin		8 weeks	No