Certoparin in Renal Patients Undergoing Hemodialysis

Novartis109 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

109

Conditions

Renal Dialysis

Interventions

CertoparinDRUG

Certoparin

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Novartis Investigative Site Darmstadt

Darmstadt, Germany

Novartis Investigative Site Elsenfeld

Elsenfeld, Germany

Novartis Investigative Site Flensburg

Flensburg, Germany

Novartis Investigative Site Heringen

Heringen, Germany

Outcomes

Primary Outcomes

Number of patients requiring uptitration

Time frame: Week 8

Secondary Outcomes

Pharmacokinetics of Certoparin

Time frame: Day 1, Week 4

Safety and tolerability of Certoparin

Time frame: 8 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.