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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00074620

Enrollment

260

Registered

2003-12-19

Start date

2003-11-30

Completion date

2006-01-31

Last updated

2007-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Failure, Vascular Graft Occlusion

Keywords

Haemodialysis, PEG-Hirudin, Vascular graft occlusion, Renal replacement therapy, Hemodialysis

Brief 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.

Interventions

DRUGPEG-hirudin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 75 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
To determine the safety and tolerability of SPP200 in patients undergoing chronic haemodialysis via an arteriovenous graft.	—

Secondary

Measure	Time frame
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.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026