Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Astellas Pharma Inc | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tacrolimus | Drug | Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Biopsy Confirmed Acute Rejection at 12 Months. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Survival. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time Post Transplant Corticosteroid Withdrawal | The mean days from post transplant corticosteroid withdrawal. | 12 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Steve Woodle, MD | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Corticosteroid Withdrawal | Discontinue prednisone at 90 days or longer post liver transplant if rejection free previous 30 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Biopsy Confirmed Acute Rejection at 12 Months. | Posted | Number | participants | 12 months |
|
2 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lower Extremity Cellulites | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allograft rejection (mild) | Renal and urinary disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| E. Steve Woodle, MD | University of Cincinnati | (513) 558-6001 | woodlees@uc.edu |
Not provided
| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D009173 | Mycophenolic Acid |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002208 | Caproates |
| D000144 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| mycophenolate mofetil | Drug | Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis. |
|
|
| Prednisone | Drug | Prednisone is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis. |
|
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Cause of Liver Disease | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Patient Survival. | Posted | Number | participants | 12 months |
|
|
|
| Other Pre-specified | Time Post Transplant Corticosteroid Withdrawal | The mean days from post transplant corticosteroid withdrawal. | Posted | Mean | Standard Deviation | days | 12 months |
|
|
|
| 9 |
| 40 |
| 3 |
| 40 |
| Acute Cerebrovascular Accident | Nervous system disorders | Non-systematic Assessment |
|
| Portal Vein Stenosis | Vascular disorders | Non-systematic Assessment |
|
| Total Knee Anthroplasty | Vascular disorders | Non-systematic Assessment |
|
| Incisional Hernia Repair | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Lymphocele | General disorders | Non-systematic Assessment |
|
| Moderate Allograft Rejection | Renal and urinary disorders | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |