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

Speedel Pharma

Status and phase

Completed

Phase 2

Conditions

Vascular Graft Occlusion

Chronic Kidney Failure

Treatments

Drug: PEG-hirudin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00074620

SPP200CRD01

Details and patient eligibility

About

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.

Sex

All

Ages

21 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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