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

Speedel Pharma Ltd.260 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

260

Conditions

Chronic Kidney Failure Vascular Graft Occlusion

Interventions

PEG-hirudinDRUG

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 Years

Medical Language ↔ Plain English

* 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

Locations (1)

Pennsylvania Hospital - Franklin Dialysis Center

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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