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.'

National Institute of Health (NIH)
National Center for Research Resources (NCRR)
General Clinical Research Centers Program (M01)
Project #
Application #
Study Section
Special Emphasis Panel (ZRR1-CR-8 (02))
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
University of Michigan Ann Arbor
Internal Medicine/Medicine
Schools of Medicine
Ann Arbor
United States
Zip Code
Robarge, Jason D; Desta, Zereunesay; Nguyen, Anne T et al. (2017) Effects of exemestane and letrozole therapy on plasma concentrations of estrogens in a randomized trial of postmenopausal women with breast cancer. Breast Cancer Res Treat 161:453-461
Crane, Natania A; Jenkins, Lisanne M; Bhaumik, Runa et al. (2017) Multidimensional prediction of treatment response to antidepressants with cognitive control and functional MRI. Brain 140:472-486
Hertz, Daniel L; Speth, Kelly A; Kidwell, Kelley M et al. (2017) Variable aromatase inhibitor plasma concentrations do not correlate with circulating estrogen concentrations in post-menopausal breast cancer patients. Breast Cancer Res Treat 165:659-668
Hertz, D L; Kidwell, K M; Seewald, N J et al. (2017) Polymorphisms in drug-metabolizing enzymes and steady-state exemestane concentration in postmenopausal patients with breast cancer. Pharmacogenomics J 17:521-527
Kadakia, Kunal C; Kidwell, Kelley M; Seewald, Nicholas J et al. (2017) Prospective assessment of patient-reported outcomes and estradiol and drug concentrations in patients experiencing toxicity from adjuvant aromatase inhibitors. Breast Cancer Res Treat 164:411-419
Spengler, Erin K; Kleiner, David E; Fontana, Robert J (2017) Vemurafenib-induced granulomatous hepatitis. Hepatology 65:745-748
Heidemann, Lauren; Law, James; Fontana, Robert J (2017) A Text Searching Tool to Identify Patients with Idiosyncratic Drug-Induced Liver Injury. Dig Dis Sci 62:615-625
Law, Ian H; Alam, Osman; Bove, Edward L et al. (2016) Follow-Up of a Prospective Surgical Strategy to Prevent Intra-Atrial Reentrant Tachycardia After the Fontan Operation. Circ Arrhythm Electrophysiol 9:
Schrepf, Andrew; Harper, Daniel E; Harte, Steven E et al. (2016) Endogenous opioidergic dysregulation of pain in fibromyalgia: a PET and fMRI study. Pain 157:2217-2225
As-Sanie, Sawsan; Kim, Jieun; Schmidt-Wilcke, Tobias et al. (2016) Functional Connectivity is Associated With Altered Brain Chemistry in Women With Endometriosis-Associated Chronic Pelvic Pain. J Pain 17:1-13

Showing the most recent 10 out of 1380 publications