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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2006-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Kidney Failure Vascular Graft Occlusion

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Haemodialysis PEG-Hirudin Vascular graft occlusion Renal replacement therapy Hemodialysis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PEG-hirudin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jessica M Mann, MD, PhD

Role: STUDY_CHAIR

Speedel Bio Ltd

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pennsylvania Hospital - Franklin Dialysis Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SPP200CRD01

Identifier Type: -

Identifier Source: org_study_id