Liver TransplantationPhase 4thymoNCT00564538
A Study of Thymoglobulin and Tacrolimus in Liver Transplant
A Phase 4 study testing anti-thymocyte globulin (rabbit) and tacrolimus in people with Liver Transplantation and Liver Disease, run by University of Nebraska at 1 site in United States.
Trial summary
The purpose of this study is to compare kidney function, long term patient and graft survival, and incidence of acute rejection in liver transplant recipients between one group receiving thymoglobulin induction and delayed initiation of tacrolimus and another group of liver transplant recipients having immediate… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Liver Transplantation, Liver Disease, Immunosuppression
- What is being tested?
- anti-thymocyte globulin (rabbit) and tacrolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Dec 2009
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary liver transplant recipient with Model for End Stage Liver Disease (MELD) criteria documentation
- Over 18 years of age
- Signed informed consent form
- if female of childbearing potential: Must not be lactating Must have negative serum pregnancy test on study day 0 Must have agreed on a reliable and acceptable form of contraception during the study
- sexually active males must be practicing an acceptable form of contraception
Who cannot join
- Multiple organ transplants
- Prior solid organ or bone marrow transplant recipients
- Fulminant hepatic failure
- Status 1 transplants
- Liver transplant candidates with greater than 6 weeks of dialysis
- Patients who in the opinion of the Investigator are not eligible for thymo induction at the time of transplant
Show all 13Show fewer
- Recipients of investigational therapy within 90 days prior to transplant
- Know contraindication to administration of rabbit anti-thymocyte globulin
- Patients whose medical condition is such that the physician feels it would not be in their best interest to participate in the study
- Patients who are unwilling to have a Glofil nuclear medicine scan at specified time points
- History of malignancy within 5 years with the exception of:
- Adequately treated localized squamous or basal cell carcinoma of the skin without evidence of recurrence, and /or
- Hepatocellular carcinoma
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: A Study Comparing Thymoglobulin to Tacrolimus in Liver Transplant and Impact on Renal Function
The purpose of this study is to compare kidney function, long term patient and graft survival, and incidence of acute rejection in liver transplant recipients between one group receiving thymoglobulin induction and delayed initiation of tacrolimus and another group of liver transplant recipients having immediate administration of tacrolimus without any induction immunosuppression.
Read the detailed description
Renal insufficiency following liver transplantation in adult recipients is a major cause of morbidity and a major contributor to mortality. One of the key factors contributing to this renal dysfunction is the use of calcineurin inhibitors. There is some evidence to suggest that the first 7-10 days following liver transplantation are crucial in terms of renal function and the ability to avoid the use of nephrotoxic agents such as calcineurin inhibitors may have a significant impact on long-term outcome.
- Conditions
- Liver Transplantation, Liver Disease, Immunosuppression
- Being tested
- anti-thymocyte globulin (rabbit), tacrolimus
- Keywords
- liver transplant
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-thymocyte globulin (rabbit)Drug
Also called thymoglobulin
1.5mg/kg per dose with the first dose initiated in the operating room prior to reperfusion of the transplanted liver. It will then be administered again on post operative day #1, 3 and 5 for a total cumulative dose of 6mg/kg.
tacrolimusDrug
Also called prograf
Tacrolimus will be administered orally on post op day #1 as per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients in arm 1 will receive induction with thymoglobulin at time of transplant with delayed initiation of tacrolimus Receives: Drug: anti-thymocyte globulin (rabbit) |
| 2 | Active comparator | patients in arm 2 will not receive thymo induction at time of transplant and will have immediate initiation of tacrolimus Receives: Drug: tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of renal function via Glo-Fil nuclear medicine scan and laboratory parameters
Measured: Post operative day #1, month 6 and month 12
Secondary outcomes (1)
patient and graft survival, incidence of acute rejection, incidence of active CMV disease, incidence of other infections, any adverse events or serious adverse events associated with the use of thymo induction therapy
Measured: post op days 1-6, months 3,6, 9, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2007 (estimated)
- Study startDec 2007
- Study completionDec 2009 (estimated)
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 Liver TransplantationStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Investigators
- Wendy Grant, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00564538
- Sponsor's protocol ID
- 424-07
- Acronym
- thymo
- Status last verified
- Nov 2007
- First submitted
- 27 Nov 2007
- Last updated
- 28 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
1. Fisher NC, Nightingale PG, Gunson BK, Lipkin GW, JM. N. Chronic renal failure following liver transplantation: a retrospective analysis Transplantation 1998; 66 (1): 59. 2. Gonwa TA, Mai ML, Melton LB, et al. End-stage renal disease (ESRD) after orthotopic lvier transplantation (OLTX) using calcineurin-based immunotherapy. Transplantation 2001; 72: 1934. 3. Moreno JM, Cuervas-Mons V, Rubio E, et al. Chronic renal dysfunction after liver transplantation in adult patients: prevelance, risk factors, and impact on mortality. Transplant Proc 2003; 35 (5): 1907.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Comparing Thymoglobulin to Tacrolimus in Liver Transplant and Impact on Renal Function
- ClinicalTrials.gov ID
- NCT00564538
- Acronym / sponsor ID
- thymo / 424-07
- Conditions
- Liver Transplantation, Liver Disease, Immunosuppression
- Keywords
- liver transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company
- Study start
- Dec 2007
- Study completion
- Dec 2009 (estimated)
- First posted
- 28 Nov 2007 (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 purpose of this study is to compare kidney function, long term patient and graft survival, and incidence of acute rejection in liver transplant recipients between one group receiving thymoglobulin induction and delayed initiation of tacrolimus and another group of liver transplant recipients having immediate administration of tacrolimus without any induction immunosuppression.
Detailed description
Renal insufficiency following liver transplantation in adult recipients is a major cause of morbidity and a major contributor to mortality. One of the key factors contributing to this renal dysfunction is the use of calcineurin inhibitors. There is some evidence to suggest that the first 7-10 days following liver transplantation are crucial in terms of renal function and the ability to avoid the use of nephrotoxic agents such as calcineurin inhibitors may have a significant impact on long-term outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: anti-thymocyte globulin (rabbit)Patients in arm 1 will receive induction with thymoglobulin at time of transplant with delayed initiation of tacrolimus |
| 2 | Active comparator | Drug: tacrolimuspatients in arm 2 will not receive thymo induction at time of transplant and will have immediate initiation of tacrolimus |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary liver transplant recipient with Model for End Stage Liver Disease (MELD) criteria documentation
- Over 18 years of age
- Signed informed consent form
- if female of childbearing potential: Must not be lactating Must have negative serum pregnancy test on study day 0 Must have agreed on a reliable and acceptable form of contraception during the study
- sexually active males must be practicing an acceptable form of contraception
Key exclusion criteria (13 listed)
- Multiple organ transplants
- Prior solid organ or bone marrow transplant recipients
- Fulminant hepatic failure
- Status 1 transplants
- Liver transplant candidates with greater than 6 weeks of dialysis
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 |
|---|---|---|
| anti-thymocyte globulin (rabbit)Also: thymoglobulin1.5mg/kg per dose with the first dose initiated in the operating room prior to reperfusion of the transplanted liver. It will then be administered again on post operative day #1, 3 and 5 for a total cumulative dose of 6mg/kg. | Drug | 1 |
| tacrolimusAlso: prografTacrolimus will be administered orally on post op day #1 as per standard of care. | Drug | 2 |
Primary outcome
Evaluation of renal function via Glo-Fil nuclear medicine scan and laboratory parameters
Time frame: Post operative day #1, month 6 and month 12
1 secondary outcome
patient and graft survival, incidence of acute rejection, incidence of active CMV disease, incidence of other infections, any adverse events or serious adverse events associated with the use of thymo induction therapy
Time frame: post op days 1-6, months 3,6, 9, and 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2007.
- Background1. Fisher NC, Nightingale PG, Gunson BK, Lipkin GW, JM. N. Chronic renal failure following liver transplantation: a retrospective analysis Transplantation 1998; 66 (1): 59. 2. Gonwa TA, Mai ML, Melton LB, et al. End-stage renal disease (ESRD) after orthotopic lvier transplantation (OLTX) using calcineurin-based immunotherapy. Transplantation 2001; 72: 1934. 3. Moreno JM, Cuervas-Mons V, Rubio E, et al. Chronic renal dysfunction after liver transplantation in adult patients: prevelance, risk factors, and impact on mortality. Transplant Proc 2003; 35 (5): 1907.
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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.
Wendy Grant, MD principal investigator
University of Nebraska
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 anti-thymocyte globulin (rabbit) and tacrolimus in people with Liver Transplantation and Liver Disease, run by University of Nebraska 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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 28 Nov 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 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?
Results are not available in the source record.
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?
Evaluation of renal function via Glo-Fil nuclear medicine scan and laboratory parameters (time frame: Post operative day #1, month 6 and month 12). 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 NCT00564538, 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 28 Nov 2007.