Single Center Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients
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|ClinicalTrials.gov Identifier: NCT00374231|
Recruitment Status : Completed
First Posted : September 11, 2006
Results First Posted : December 29, 2015
Last Update Posted : December 29, 2015
|Condition or disease||Intervention/treatment||Phase|
|Liver Transplantation||Drug: tacrolimus Drug: mycophenolate mofetil Drug: Prednisone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Center, Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients Utilizing a Tacrolimus/Mycophenolate Mofetil Based Maintenance Immunosuppression Protocol|
|Study Start Date :||October 2002|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||January 2008|
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.
Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.
Other Name: Prograf, FK506
Drug: 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.
Other Name: MMF, CellCept
Prednisone is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.
Other Name: corticosteriods
- Incidence of Biopsy Confirmed Acute Rejection at 12 Months. [ Time Frame: 12 months ]
- Patient Survival. [ Time Frame: 12 months ]
- Time Post Transplant Corticosteroid Withdrawal [ Time Frame: 12 months ]The mean days from post transplant corticosteroid withdrawal.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00374231
|United States, Ohio|
|University of Cincinnati|
|Cincinnati, Ohio, United States, 45267|
|Principal Investigator:||Steve Woodle, MD||University of Cincinnati|