Liver Transplantation
Conditions
Keywords
Liver, Transplant, Corticosteroid withdrawal, Tacrolimus, CellCept, MMF, Mycophenolate mofetil
Brief 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.
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.
Interventions
DRUGtacrolimus
Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.
DRUGmycophenolate mofetil
Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.
DRUGPrednisone
Prednisone is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.
Sponsors
Astellas Pharma Inc
University of Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Biopsy Confirmed Acute Rejection at 12 Months. | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Patient Survival. | 12 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time Post Transplant Corticosteroid Withdrawal | 12 months | The mean days from post transplant corticosteroid withdrawal. |
Countries
United States
Participant flow
Recruitment details
From 3/2003 to 11/2005 forty adult deceased donor liver transplant recipients were enrolled. Subjects were eligible once they were greater than 90 days post liver transplant provided they had a 30 day rejection free period prior to enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Tacrolimus and Mycophenolate Mofetil All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short coarse 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.
tacrolimus : Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.
mycophenolate mofetil : Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis. | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Tacrolimus and Mycophenolate Mofetil |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants |
| Age, Continuous | 51 years STANDARD_DEVIATION 12 |
| Cause of Liver Disease Alcoholic Liver Disease | 9 participants |
| Cause of Liver Disease Autoimmune Hepatitis | 1 participants |
| Cause of Liver Disease Cryptogenic Cirrhosis | 6 participants |
| Cause of Liver Disease Hepatocellular Carcinoma | 6 participants |
| Cause of Liver Disease Non-alcholic Steatohepatitis | 2 participants |
| Cause of Liver Disease Other | 4 participants |
| Cause of Liver Disease Primary Schlerosing Cholangitis | 6 participants |
| Cause of Liver Disease Viral Hepatitis C | 6 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 36 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 40 |
| serious Total, serious adverse events | 9 / 40 |
Outcome results
Primary
Incidence of Biopsy Confirmed Acute Rejection at 12 Months.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Corticosteroid Withdrawa. | Incidence of Biopsy Confirmed Acute Rejection at 12 Months. | 5 participants |
Secondary
Patient Survival.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Corticosteroid Withdrawa. | Patient Survival. | 39 participants |
Other Pre-specified
Time Post Transplant Corticosteroid Withdrawal
The mean days from post transplant corticosteroid withdrawal.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corticosteroid Withdrawa. | Time Post Transplant Corticosteroid Withdrawal | 257 days | Standard Deviation 511 |