NCT00074620

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 19, 2003

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

October 5, 2007

Status Verified

October 1, 2007

First QC Date

December 17, 2003

Last Update Submit

October 4, 2007

Conditions

Chronic Kidney FailureVascular Graft Occlusion

Keywords

HaemodialysisPEG-HirudinVascular graft occlusionRenal replacement therapyHemodialysis

Outcome Measures

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.

Interventions

PEG-hirudinDRUG

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Pennsylvania Hospital - Franklin Dialysis Center

Philadelphia, Pennsylvania, 19106, United States

Location

Related Links

MeSH Terms

Conditions

Kidney Failure, ChronicGraft Occlusion, Vascular

Interventions

polyethyleneglycol-hirudin

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative Complications

Study Officials

  • Jessica M Mann, MD, PhD

    Speedel Bio Ltd

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 17, 2003

First Posted

December 19, 2003

Study Start

November 1, 2003

Study Completion

January 1, 2006

Last Updated

October 5, 2007

Record last verified: 2007-10

Locations

US(1)