Chronic Kidney FailurePhase 2NCT00074620
A Clinical Study to Assess the Safety of PEG-Hirudin (SPP200) Compared to Heparin in Patients Who Are on Haemodialysis
A Phase 2 study testing PEG-hirudin in people with Chronic Kidney Failure and Vascular Graft Occlusion, run by Speedel Pharma Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Chronic Kidney Failure, Vascular Graft Occlusion
- What is being tested?
- PEG-hirudin
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Jan 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennsylvania Hospital - Franklin Dialysis Center
Philadelphia, Pennsylvania, 19106
About this study
Official title: 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
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.
- Conditions
- Chronic Kidney Failure, Vascular Graft Occlusion
- Being tested
- PEG-hirudin
- Keywords
- Haemodialysis, PEG-Hirudin, Vascular graft occlusion, Renal replacement therapy, Hemodialysis
- Medical subject headings
- Kidney Failure, Chronic, Graft Occlusion, Vascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-hirudinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2003 (estimated)
- Study startNov 2003
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants
Sponsor and investigators
- Lead sponsor
- Speedel Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Investigators
- Jessica M Mann, MD, PhD, Study chair, Speedel Bio Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00074620
- Sponsor's protocol ID
- SPP200CRD01
- Status last verified
- Oct 2007
- First submitted
- 17 Dec 2003
- Last updated
- 5 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00074620
- Acronym / sponsor ID
- SPP200CRD01
- Conditions
- Chronic Kidney Failure, Vascular Graft Occlusion
- Keywords
- Haemodialysis, PEG-Hirudin, Vascular graft occlusion, Renal replacement therapy, Hemodialysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants
- Lead sponsor
- Speedel Pharma Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Nov 2003
- Study completion
- Jan 2006
- First posted
- 19 Dec 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEG-hirudin | Drug | – |
Primary outcome
To determine the safety and tolerability of SPP200 in patients undergoing chronic haemodialysis via an arteriovenous graft.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2007.
- The National Kidney Foundation is a voluntary organisation which seeks to prevent kidney diseases, improve the health of patients and increase the availability of organs for transplantationLink provided by the sponsor.
- The American Association of Kidney Patients helps kidney patients and their families deal with the physical, emotional and social impact of kidney diseasesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica M Mann, MD, PhD study chair
Speedel Bio Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PEG-hirudin in people with Chronic Kidney Failure and Vascular Graft Occlusion, run by Speedel Pharma Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the safety and tolerability of SPP200 in patients undergoing chronic haemodialysis via an arteriovenous graft.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2007.