This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.You are about to receive a liver transplant because you have end-stage liver disease. After you receive a liver transplant, you will need to take immunosuppression (anti-rejection) medication to prevent your immune system from trying to attack or reject the newly transplanted liver. Until now, most patients have been required to stay on anti- rejection medication for the rest of their lives. All anti-rejection medications have side effects. Therefore, it may be helpful if an anti-rejection medication could be taken for a short period of time, then decreased, and eventually stopped, without a person losing (rejecting) the transplanted liver. If the body accepts the transplanted liver without the need for anti-rejection medications, this is called tolerance. This study will evaluate whether a combination of anti-rejection medications, Campath-1H and our standard anti-rejection drug tacrolimus (Prograf) can prevent rejection and allow the body to develop tolerance to the transplanted liver. Campath-1H is a new type of anti-rejection medication that may be effective in preventing a person's immune system from trying to attack or reject the newly transplanted organ. The US Food and Drug Administration (FDA) has approved Campth-1H for use in cancer treatment, however, its use in liver transplantation is still considered experimental research. Campath-1H works by removing the white blood cells from your body to protect you from rejection. It takes approximately 6 months for most of the cells to grow back. If you decide to enroll in this study, your participation will last up to 4 years (48 months) and you will be asked to come back to the clinic or the hospital to have additional lab testing done throughout that 4-year period. This testing will include blood draws for lab tests and additional liver biopsies (removal of a small piece of your transplanted liver by piercing the skin with a needle). If everything is working well one year after the transplant then the anti-rejection medication (tacrolimus) will be gradually reduced and eventually stopped. You will be monitored closely throughout the study and you must be stable, not currently undergoing treatment for rejection and receive the approval of the study physicians before you begin the withdrawal phase. If the study physician determines that it is appropriate for you to gradually withdraw tacrolimus and if you sign a separate withdrawal consent, then you will become part of the tolerance (withdrawal) portion of this study.'

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000042-47
Application #
7603777
Study Section
Special Emphasis Panel (ZRR1-CR-8 (02))
Project Start
2007-03-01
Project End
2007-09-16
Budget Start
2007-03-01
Budget End
2007-09-16
Support Year
47
Fiscal Year
2007
Total Cost
$6,101
Indirect Cost
Name
University of Michigan Ann Arbor
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
073133571
City
Ann Arbor
State
MI
Country
United States
Zip Code
48109
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