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

NCT00074620 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2007-10-05

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Kidney Failure
  • Vascular Graft Occlusion

Interventions

DRUG

PEG-hirudin

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Speedel Pharma Ltd.

    lead INDUSTRY

Principal Investigators

  • Jessica M Mann, MD, PhD · Speedel Bio Ltd

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-11-30
Completion
2006-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00074620 on ClinicalTrials.gov