Liver TransplantationPhase 4NCT00374231
Single Center Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients
A Phase 4 study testing tacrolimus, mycophenolate mofetil and Prednisone in people with Liver Transplantation, run by University of Cincinnati at 1 site in United States.
Trial summary
To determine the safety and efficacy of early corticosteroid discontinuation in liver transplant recipients more than 90 days post transplant, utilizing a combination of two drugs (tacrolimus and mycophenolate mofetil) for maintenance immunosuppressant therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- tacrolimus, mycophenolate mofetil and Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Jan 2008
- Phase
- Phase 4
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Greater than 90 days post transplant.
- Free from rejection within the last 30 days.
- Patient with primary diagnosis of AIH will be evaluated on an individual basis.
- Negative pregnancy test.
- Practicing an acceptable method of birth control.
- Capable of providing written informed consent.
Who cannot join
- Rejection within the last 30 days.
- Patients with AIH unable to discontinue corticosteroids.
- Patients currently receiving systemic corticosteroids for other medical diseases in which the physician feels discontinuation is contraindicated.
- Known sensitivity or contraindication to tacrolimus or MMF.
- Kidney, pancreas, islet, heart, lung, or small bowel transplant recipient.
- Pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients Utilizing a Tacrolimus/Mycophenolate Mofetil Based Maintenance Immunosuppression Protocol
To determine the safety and efficacy of early corticosteroid discontinuation in liver transplant recipients more than 90 days post transplant, utilizing a combination of two drugs (tacrolimus and mycophenolate mofetil) for maintenance immunosuppressant therapy.
Read the detailed description
To determine the safety and efficacy of early corticosteroid discontinuation in liver transplant recipients more than 90 days post transplant, utilizing a combination of two drugs (tacrolimus and mycophenolate mofetil) for maintenance immunosuppression therapy.
- Conditions
- Liver Transplantation
- Being tested
- tacrolimus, mycophenolate mofetil, Prednisone
- Keywords
- Liver, Transplant, Corticosteroid withdrawal, Tacrolimus, CellCept, MMF, Mycophenolate mofetil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tacrolimusDrug
Also called Prograf, FK506
Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.
Also called MMF, CellCept
Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.
PrednisoneDrug
Also called corticosteriods
Prednisone is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.
| Study group | Role | What they receive |
|---|---|---|
| Immunosuppression | Experimental | All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short course of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days. Receives: Drug: tacrolimus; Drug: mycophenolate mofetil; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Biopsy Confirmed Acute Rejection at 12 Months.
Measured: 12 months
Secondary outcomes (1)
Patient Survival.
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 posted11 Sep 2006 (estimated)
- Study startOct 2002
- Primary completionJan 2008
- Study completionJan 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.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Principal investigator, E. Steve Woodle, University of Cincinnati
- Investigators
- Steve Woodle, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374231
- Sponsor's protocol ID
- CSWD Liver
- Status last verified
- Nov 2015
- First submitted
- 8 Sep 2006
- Last updated
- 29 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients Utilizing a Tacrolimus/Mycophenolate Mofetil Based Maintenance Immunosuppression Protocol
- ClinicalTrials.gov ID
- NCT00374231
- Acronym / sponsor ID
- CSWD Liver
- Conditions
- Liver Transplantation
- Keywords
- Liver, Transplant, Corticosteroid withdrawal, Tacrolimus, CellCept, MMF, Mycophenolate mofetil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc
- Study start
- Oct 2002
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 11 Sep 2006 (estimated)
- Results
- Posted 29 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the safety and efficacy of early corticosteroid discontinuation in liver transplant recipients more than 90 days post transplant, utilizing a combination of two drugs (tacrolimus and mycophenolate mofetil) for maintenance immunosuppressant therapy.
Detailed description
To determine the safety and efficacy of early corticosteroid discontinuation in liver transplant recipients more than 90 days post transplant, utilizing a combination of two drugs (tacrolimus and mycophenolate mofetil) for maintenance immunosuppression therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immunosuppression | Experimental | Drug: tacrolimus, Drug: mycophenolate mofetil, Drug: PrednisoneAll the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short course of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Greater than 90 days post transplant.
- Free from rejection within the last 30 days.
- Patient with primary diagnosis of AIH will be evaluated on an individual basis.
- Negative pregnancy test.
- Practicing an acceptable method of birth control.
Key exclusion criteria (6 listed)
- Rejection within the last 30 days.
- Patients with AIH unable to discontinue corticosteroids.
- Patients currently receiving systemic corticosteroids for other medical diseases in which the physician feels discontinuation is contraindicated.
- Known sensitivity or contraindication to tacrolimus or MMF.
- Kidney, pancreas, islet, heart, lung, or small bowel transplant recipient.
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 |
|---|---|---|
| tacrolimusAlso: Prograf, FK506Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis. | Drug | Immunosuppression |
| mycophenolate mofetilAlso: MMF, CellCeptMycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis. | Drug | Immunosuppression |
| PrednisoneAlso: corticosteriodsPrednisone is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis. | Drug | Immunosuppression |
Primary outcome
Incidence of Biopsy Confirmed Acute Rejection at 12 Months.
Time frame: 12 months
1 secondary outcome
Patient Survival.
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 29 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Steve Woodle, MD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tacrolimus, mycophenolate mofetil and Prednisone in people with Liver Transplantation, run by University of Cincinnati 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?
The sponsor lists 6 inclusion and 6 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 29 Dec 2015. 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 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?
Yes. Results are posted in the registry (first posted 29 Dec 2015). 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?
Incidence of Biopsy Confirmed Acute Rejection at 12 Months. (time frame: 12 months). 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 29 Dec 2015.