Liver TransplantationPhase 3NCT00086346
Study Evaluating of Calcineurin Inhibitor and Sirolimus (Rapamune) Treatment in Liver Transplant Recipients
A Phase 3 study testing Sirolimus (Rapamune) and Cyclosporine or Tacrolimus in people with Liver Transplantation, run by Wyeth is now a wholly owned subsidiary of Pfizer at 42 sites in 12 countries.
Trial summary
The purpose of this study is to evaluate the sirolimus conversion regimen as compared with the calcineurin inhibitor continuation regimen with regards to renal function in stable liver transplant subjects. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- Sirolimus (Rapamune) and Cyclosporine or Tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 607 participants
- Where
- 42 sitesin 12 countries
- Study dates
- Dec 2002to Jul 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age greater than 13 years (age greater than 18 years as required by some local regulations).
- Receiving immunosuppressive therapy with calcineurin inhibitors (CI) +/- corticosteroids +/- antimetabolite.
- 6 to 144 months after orthotopic liver transplantation.
- Cockcroft-Gault GFR values ≥40 mL/min and ≤90mL/min at screening
Who cannot join
- History of nonhepatic transplantation
- Evidence of systemic infection (sepsis, bacteremia, pneumonia etc).
- Known or suspected malignancy < 5 years before random assignment.
Trial locations and contacts
42 sites in 12 countries.
42 sites in 12 countries
United States10 sites
Study site
Cleveland, Ohio, 44195
Study site
Detroit, Michigan, 48202
Study site
New Orleans, Louisiana, 70121
Study site
New York, New York, 10029
Study site
Omaha, Nebraska, 68198-3285
Study site
Philadelphia, Pennsylvania, 19104
Study site
Rochester, Minnesota, 55905
Study site
Rochester, New York, 14642-8410
Study site
San Francisco, California, 94143-0780
Study site
Tampa, Florida, 33606
Spain7 sites
Study site
Barcelona, 08035
Study site
Barcelona, 08036
Study site
Barcelona, 08907
Study site
Madrid, 28034
Study site
Pamplona, 31008
Study site
Santiago de Compostela, 15706
Study site
Valencia, 46009
France6 sites
Study site
Clichy, 92118
Study site
Lyon, 69437
Study site
Nice, 06200
Study site
Paris, 75679
Study site
Rennes, 35033
Study site
Villejuif, 94800
Canada3 sites
Study site
Edmonton, Alberta, T6G 2B7
Study site
London, Ontario, N6A 5A5
Study site
Toronto, Ontario, M5G 2C4
Germany3 sites
Study site
Berlin, 13353
Study site
Hamburg, 20251
Study site
München, 81377
United Kingdom3 sites
Study site
Birmingham, B15 2TH
Study site
Edinburgh, EH16 4SA
Study site
Leeds, LS9 7TF
About this study
Official title: A Randomized, Open-Label, Comparative Evaluation of Conversion From Calcineurin Inhibitor Treatment to Sirolimus Treatment Versus Continued Calcineurin Inhibitor Treatment in Liver Allograft Recipients Undergoing Maintenance Therapy
The purpose of this study is to evaluate the sirolimus conversion regimen as compared with the calcineurin inhibitor continuation regimen with regards to renal function in stable liver transplant subjects.
- Conditions
- Liver Transplantation
- Being tested
- Sirolimus (Rapamune), Cyclosporine or Tacrolimus
- Keywords
- Liver, Transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sirolimus (Rapamune)Drug
Cyclosporine or TacrolimusDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: Sirolimus (Rapamune) |
| B | Active comparator | Not described Receives: Drug: Cyclosporine or Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Adjusted Mean in Glomerular Filtration Rate (GFR)
GFR is an index of kidney function. GFR was calculated using Cockcroft-Gault method. A normal GFR is >90 mL/min, higher values indicate better function. Change=adjusted mean of 12 months minus baseline. Mean adjusted for baseline GFR, with antimetabolite therapy status and hepatitis C status as fixed effects.
Measured: Baseline and 12 months
Patient and Graft Survival
Endpoint was a composite assessment of patient and graft survival. Patients categorized as graft survival or graft loss. Graft loss defined as pure graft loss (requiring retransplant) or death (with a functioning graft), if the event occurred in the first 12 months after randomization. Patients with missing graft data were counted as graft losses.
Measured: 12 months
Secondary outcomes (2)
Number of Patients With a Biopsy Confirmed Acute Rejection
Overall event rate is determined as yes or no.
Measured: 12 months
Mean Serum Creatinine
Observed mean values for serum creatinine.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2004 (estimated)
- Study startDec 2002
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 607 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of PfizerTrial Manager, Principal investigator, For Italy, decresg@wyeth.comTrial Manager, Principal investigator, For Germany, MedInfoDEU@wyeth.comTrial Manager, Principal investigator, For Belgium, trials-BEL@wyeth.comTrial Manager, Principal investigator, For Czech Republic, WPPGCLI@wyeth.comTrial Manager, Principal investigator, For Netherlands, trials-NL@wyeth.comTrial Manager, Principal investigator, For Switzerland, med@wyeth.comTrial Manager, Principal investigator, For UK, ukmedinfo@wyeth.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00086346
- Sponsor's protocol ID
- 0468H1-313
- Status last verified
- Apr 2010
- First submitted
- 30 Jun 2004
- Last updated
- 28 Apr 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Comparative Evaluation of Conversion From Calcineurin Inhibitor Treatment to Sirolimus Treatment Versus Continued Calcineurin Inhibitor Treatment in Liver Allograft Recipients Undergoing Maintenance Therapy
- ClinicalTrials.gov ID
- NCT00086346
- Acronym / sponsor ID
- 0468H1-313
- Conditions
- Liver Transplantation
- Keywords
- Liver, Transplant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 607 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 2 Jul 2004 (estimated)
- Results
- Posted 7 Sep 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the sirolimus conversion regimen as compared with the calcineurin inhibitor continuation regimen with regards to renal function in stable liver transplant subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Sirolimus (Rapamune) |
| B | Active comparator | Drug: Cyclosporine or Tacrolimus |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater than 13 years (age greater than 18 years as required by some local regulations).
- Receiving immunosuppressive therapy with calcineurin inhibitors (CI) +/- corticosteroids +/- antimetabolite.
- 6 to 144 months after orthotopic liver transplantation.
- Cockcroft-Gault GFR values ≥40 mL/min and ≤90mL/min at screening
Key exclusion criteria (3 listed)
- History of nonhepatic transplantation
- Evidence of systemic infection (sepsis, bacteremia, pneumonia etc).
- Known or suspected malignancy < 5 years before random assignment.
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 |
|---|---|---|
| Sirolimus (Rapamune) | Drug | A |
| Cyclosporine or Tacrolimus | Drug | B |
Primary outcome
Change From Baseline Adjusted Mean in Glomerular Filtration Rate (GFR)
Time frame: Baseline and 12 months
GFR is an index of kidney function. GFR was calculated using Cockcroft-Gault method. A normal GFR is >90 mL/min, higher values indicate better function. Change=adjusted mean of 12 months minus baseline. Mean adjusted for baseline GFR, with antimetabolite therapy status and hepatitis C status as fixed effects.
Patient and Graft Survival
Time frame: 12 months
Endpoint was a composite assessment of patient and graft survival. Patients categorized as graft survival or graft loss. Graft loss defined as pure graft loss (requiring retransplant) or death (with a functioning graft), if the event occurred in the first 12 months after randomization. Patients with missing graft data were counted as graft losses.
2 secondary outcomes
Number of Patients With a Biopsy Confirmed Acute Rejection
Time frame: 12 months
Mean Serum Creatinine
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Trial Manager principal investigator
For Italy, decresg@wyeth.com
Trial Manager principal investigator
For Germany, MedInfoDEU@wyeth.com
42 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sirolimus (Rapamune) and Cyclosporine or Tacrolimus in people with Liver Transplantation, run by Wyeth is now a wholly owned subsidiary of Pfizer at 42 sites in 12 countries.
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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 28 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Spain, France, Canada, Germany and 7 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Sep 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline Adjusted Mean in Glomerular Filtration Rate (GFR) (time frame: Baseline and 12 months). The study lists 2 primary outcomes in all. 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 28 Apr 2010.