Corneal TransplantationPhase 2NCT00409656
Prospective, Randomized Trial of Basiliximab (Simulect) in the Prophylaxis of High-Risk Keratoplasty Patients
A Phase 2 study testing Basiliximab in people with Corneal Transplantation, run by University Hospital Freiburg.
Trial summary
Most high risk keratoplasties are currently performed under systemic immunosuppression. Immunosuppressants are currently either Cyclosporine A or mycophenolate mofetile, administered for around 6 months. Due to potentially severe adverse effects, new immunosuppressive exerting less side effects would be desirable. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Corneal Transplantation
- What is being tested?
- Basiliximab
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Dec 2003to Dec 2005
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- high risk keratoplasty
Who cannot join
- normal risk keratoplasty
About this study
Most high risk keratoplasties are currently performed under systemic immunosuppression. Immunosuppressants are currently either Cyclosporine A or mycophenolate mofetile, administered for around 6 months. Due to potentially severe adverse effects, new immunosuppressive exerting less side effects would be desirable. Basiliximab is a monoclonal, chimeric antibody, targeted specifically against the Interleukin-2-Rezeptor from activated T-cells. This agent is known to specifically inhibit T-cell proliferation upon intravenous application only twice following transplantation. Basiliximab has already been demonstrated effective in kidney transplantation.
This investigation is a prospective, randomized clinical trial on orthotopic, high-risk penetrating keratoplasty. Basiliximab is evaluated against systemic Cyclosporine A. Primary endpoint is graft rejection. Secondary endpoint is clear graft survival.
- Conditions
- Corneal Transplantation
- Being tested
- Basiliximab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BasiliximabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft rejection
Secondary outcomes (1)
Clear graft survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2006 (estimated)
- Study startDec 2003
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Corneal TransplantationStudies 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)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Investigators
- Thomas Reinhard, MD, Prof., Study director, University Eye Hospital, Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409656
- Sponsor's protocol ID
- FR-2003-12-2005-12
- Status last verified
- Dec 2006
- First submitted
- 8 Dec 2006
- Last updated
- 13 Dec 2006
- Results posted
- No
Publications
Abudou M, Wu T, Evans JR, Chen X. Immunosuppressants for the prophylaxis of corneal graft rejection after penetrating keratoplasty. Cochrane Database Syst Rev. 2015 Aug 27;2015(8):CD007603. doi: 10.1002/14651858.CD007603.pub2.
PubMed 26313245
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Trial of Basiliximab (Simulect) in the Prophylaxis of High-Risk Keratoplasty Patients
- ClinicalTrials.gov ID
- NCT00409656
- Acronym / sponsor ID
- FR-2003-12-2005-12
- Conditions
- Corneal Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Study start
- Dec 2003
- Study completion
- Dec 2005
- First posted
- 11 Dec 2006 (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.
Most high risk keratoplasties are currently performed under systemic immunosuppression. Immunosuppressants are currently either Cyclosporine A or mycophenolate mofetile, administered for around 6 months. Due to potentially severe adverse effects, new immunosuppressive exerting less side effects would be desirable. Basiliximab is a monoclonal, chimeric antibody, targeted specifically against the Interleukin-2-Rezeptor from activated T-cells. This agent is known to specifically inhibit T-cell proliferation upon intravenous application only twice following transplantation. Basiliximab has already been demonstrated effective in kidney transplantation.
This investigation is a prospective, randomized clinical trial on orthotopic, high-risk penetrating keratoplasty. Basiliximab is evaluated against systemic Cyclosporine A. Primary endpoint is graft rejection. Secondary endpoint is clear graft survival.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- high risk keratoplasty
Key exclusion criteria (1 listed)
- normal risk keratoplasty
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 |
|---|---|---|
| Basiliximab | Drug | – |
Primary outcome
Graft rejection
1 secondary outcome
Clear graft survival
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 13 Dec 2006.
- Derived from this study: PubMed 26313245Abudou M, Wu T, Evans JR, Chen X. Immunosuppressants for the prophylaxis of corneal graft rejection after penetrating keratoplasty. Cochrane Database Syst Rev. 2015 Aug 27;2015(8):CD007603. doi: 10.1002/14651858.CD007603.pub2.
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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.
Thomas Reinhard, MD, Prof. study director
University Eye Hospital, Freiburg
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Basiliximab in people with Corneal Transplantation, run by University Hospital Freiburg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 13 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
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?
Graft rejection. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00409656, which also lists 1 linked publication.
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 13 Dec 2006.