Efficacy and Local Tolerability of Topically Applied Heparin on the Suitability of Newly Constructed Primary Arteriovenous Fistulas in Patients Planned for Haemodialysis

• Status: Terminated
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the effect of topically applied heparin in comparison to placebo on suitability of newly constructed primary arteriovenous fistulas in patients planned for haemodialysis at 7th week (± 1 week) after first study drug administration.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cyathus Exquirere Pharmaforschungsgmbh
• Treatments: Calcium heparin; Heparin

Criteria

Inclusion Criteria:

• Male and/or female outpatients

• Aged over 18 years

• Stage 4 or 5 Chronic kidney Disease according to KDOQI classification

• Surgery to create an arteriovenous fistula in the lower arm is planned

• If female of childbearing potential: agree to maintain reliable birth control throughout the study and negative (urine) pregnancy test

Exclusion Criteria:

• Known hypersensitivity to any component of the study medication

• History of previous arm (side of planned AVF), neck, or chest surgery/trauma

• Anticipated kidney transplant from living donor within the next 3 months

• Presence of any comorbidity that limits patient's life expectancy to less than 6 months.

• Pregnancy / lactation or intention to fall pregnant during the time course of the study and women of childbearing potential who are not using adequate contraception

• Known bleeding disorder or established diagnosis of active or suspected bleeding

• Platelet count less than 80 x 10^9/L

• Uncontrolled hypertension: Diastolic blood pressure > 115 mm Hg or Systolic blood pressure > 200 mm Hg