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CompletedNCT00074620Updated Oct 5, 2007

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

A Phase 2 interventional study of PEG-hirudin in Chronic Kidney Failure and Vascular Graft Occlusion, sponsored by Speedel Pharma Ltd.. Completed at 1 site in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2007-10-05.

Sponsored by Speedel Pharma Ltd. · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
260
Allocation
Randomized
Ages
21 Years to 75 Years
Sex
All
01

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.

02

Conditions studied

  • Chronic Kidney Failure
  • Vascular Graft Occlusion

Keywords

  • Haemodialysis
  • PEG-Hirudin
  • Vascular graft occlusion
  • Renal replacement therapy
  • Hemodialysis
03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 260 is above the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Speedel Pharma Ltd. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
260 participants

Interventions

  • DrugPEG-hirudin
06

What researchers measure

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.

07

Study locations

1 site
  • Pennsylvania Hospital - Franklin Dialysis Center
    Philadelphia, Pennsylvania 19106, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00074620
Lead sponsor
Speedel Pharma Ltd.
Collaborators
Quintiles, Inc.
First posted
Dec 19, 2003
Start date
Nov 2003
Completion
Jan 2006
Last update
Oct 5, 2007

Study contacts

Jessica M Mann, MD, PhD
study chair · Speedel Bio Ltd

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.

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