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Completed

NCT Number: NCT00074620

A Clinical Study to Assess the Safety of PEG-Hirudin (SPP200) Compared to Heparin in Patients Who Are on Haemodialysis

The study will look at the safety profile (unwanted effects) of the long-lasting anticoagulant PEG-hirudin (SPP200) and compare these unwanted effects to those of unfractionated heparin, commonly used in haemodialysis to avoid clotting of the graft and of the haemodialysis machine.

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Key information

Conditions

Chronic Kidney Failure Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Graft Occlusion, Vascular Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Graft Occlusion

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pennsylvania Hospital - Franklin Dialysis Center

Philadelphia, Pennsylvania, 19106, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Patients undergoing chronic haemodialysis via an arteriovenous graft
  • Arteriovenous graft in place for at least 3 months
  • Duration of haemodialysis of at least 3 months, with 3 full dialysis sessions per week with a duration between 2 and 5 hours per session
  • Women patients must be either postmenopausal for more than 1 year or, if of childbearing age, must use adequate contraception
  • Women patients must have a negative serum pregnancy test within one week of randomisation
  • Able to provide written informed consent prior to study participation

Treatment and study plan

PEG-hirudin

Drug

Primary outcomes

  1. To determine the safety and tolerability of SPP200 in patients undergoing chronic haemodialysis via an arteriovenous graft.

Secondary outcomes

  1. To determine the efficacy of PEG-hirudin compared to unfractionated heparin (UFH) on the frequency of vascular graft occlusions and on time to first graft occlusions.

Sponsors and collaborators

Lead sponsor

Speedel Pharma Ltd.

Industry

Collaborators

  • Quintiles, Inc.

Registry information

Official study title

A Randomised, Multicenter, Open-Label, Parallel Group Study to Assess the Safety of PEG-Hirudin (SPP200) Compared to Unfractionated Heparin as Anticoagulant Treatment in Patients Undergoing Haemodialysis Via an Arteriovenous Graft

Important dates

Study start
2003
Study completion
2006
First posted
Dec 19, 2003
Registry last updated
Oct 5, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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