Liver TransplantationPhase 4NCT00343226
An Open, Randomized Pilot Study to Evaluate the Use of Basiliximab With an Optimized Cyclosporine Dosing on Renal Function in "de Novo" Liver Transplantation.
A Phase 4 study testing Basiliximab in people with Liver Transplantation, run by Novartis.
Trial summary
The objectives of the study are:To compare the renal function of a quadruple immunosuppressive regimen (including basiliximab in combination with an optimized cyclosporine dose during the first weeks post-transplantation, mycophenolate mofetil and corticosteroids) versus a standard triple therapy regimen (including… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Basiliximab
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- May 2002to Apr 2005
- Phase
- Phase 4
- 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 18 to 75 years
- All sexes
- Adult, Older adult
Who may be able to join
- First cadaveric liver transplant
- ABO identical or compatible graft
Who cannot join
- Multiple organ transplant
- renal impairment defined as glomerular filtration rate (GFR) < 30 ml/min
- Fulminant liver failure
- Other protocol-defined exclusion criteria may apply.
About this study
The objectives of the study are:To compare the renal function of a quadruple immunosuppressive regimen (including basiliximab in combination with an optimized cyclosporine dose during the first weeks post-transplantation, mycophenolate mofetil and corticosteroids) versus a standard triple therapy regimen (including cyclosporine standard dose, mycophenolate mofetil and corticosteroids)
- Conditions
- Liver Transplantation
- Being tested
- Basiliximab
- Keywords
- Basiliximab, transplantation, liver, renal function
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.
Renal function (i.e. glomerular filtration rate) at 12 months post-transplantation
Secondary outcomes (4)
Frequency and severity of rejection episodes before 6 and 12 months post-transplantation
Frequency of death, graft loss or retransplantation before 6 and 12 months post-transplantation
Adverse events
Duration of initial hospitalization and number or hospital re-admissions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2006 (estimated)
- Study startMay 2002
- Primary completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00343226
- Sponsor's protocol ID
- CCHI621ABE02
- Status last verified
- Aug 2010
- First submitted
- 30 May 2006
- Last updated
- 25 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Randomized Pilot Study to Evaluate the Use of Basiliximab With an Optimized Cyclosporine Dosing on Renal Function in "de Novo" Liver Transplantation.
- ClinicalTrials.gov ID
- NCT00343226
- Acronym / sponsor ID
- CCHI621ABE02
- Conditions
- Liver Transplantation
- Keywords
- Basiliximab, transplantation, liver, renal function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- May 2002
- Primary completion
- Apr 2005 (actual)
- First posted
- 22 Jun 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.
The objectives of the study are:To compare the renal function of a quadruple immunosuppressive regimen (including basiliximab in combination with an optimized cyclosporine dose during the first weeks post-transplantation, mycophenolate mofetil and corticosteroids) versus a standard triple therapy regimen (including cyclosporine standard dose, mycophenolate mofetil and corticosteroids)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- First cadaveric liver transplant
- ABO identical or compatible graft
Key exclusion criteria (4 listed)
- Multiple organ transplant
- renal impairment defined as glomerular filtration rate (GFR) < 30 ml/min
- Fulminant liver failure
- Other protocol-defined exclusion criteria may apply.
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
Renal function (i.e. glomerular filtration rate) at 12 months post-transplantation
4 secondary outcomes
Frequency and severity of rejection episodes before 6 and 12 months post-transplantation
Frequency of death, graft loss or retransplantation before 6 and 12 months post-transplantation
Adverse events
Duration of initial hospitalization and number or hospital re-admissions.
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 25 Aug 2010.
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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.
Novartis study director
Novartis
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Basiliximab in people with Liver Transplantation, run by Novartis.
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 2 inclusion and 4 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 25 Aug 2010. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Renal function (i.e. glomerular filtration rate) at 12 months post-transplantation. 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 25 Aug 2010; AzTrials last refreshed its copy on 28 Oct 2026.