Results of a phase 4 trial of Tacrobell® in liver transplantation patients: A multicenter study in South Korea

Hepato-Gastroenterology

Volumn 59, Issue 114, 2012, Pages 357-363

  Yu, Young Dong ^a   Lee, Sung Gyu ^a   Joh, Jae Won ^b   Kwon, Choon Hyuck ^b   Kim, Dong Gu ^c   Suh, Kyung Suk ^d   Lee, Nam Jun ^d   Hwang, Shin ^a   Ahn, Chul Soo ^a   Kim, Ki Hun ^a   Moon, Deok Bog ^a   Ha, Tae Yong ^a   Song, Gi Won ^a   Jung, Dong Hwan ^a  

^a University of Ulsan College of Medicine   (South Korea)

^b Sungkyunkwan University School of Medicine   (South Korea)

^c The Catholic University of Korea College of Medicine   (South Korea)

^d Seoul National University College of Medicine   (South Korea)

Author keywords

Acute rejection; Liver transplantation; Tacrobell

Indexed keywords

BASILIXIMAB; METHYLPREDNISOLONE; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; TACROBELL; TACROLIMUS; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ACUTE GRAFT REJECTION; ACUTE LIVER FAILURE; ADULT; ALBUMINURIA; ALCOHOL LIVER CIRRHOSIS; ALOPECIA; ARTICLE; BACTERIAL INFECTION; BILE DUCT OBSTRUCTION; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DIARRHEA; DIASTOLIC BLOOD PRESSURE; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DYSURIA; ELECTROLYTE DISTURBANCE; ENDOCRINE DISEASE; FEMALE; GASTROINTESTINAL DISEASE; GRAFT RECIPIENT; GRAFT SURVIVAL; HEPATITIS B; HEPATITIS C; HEPATOBILIARY DISEASE; HUMAN; HYPERBILIRUBINEMIA; HYPERCHOLESTEROLEMIA; HYPERTRIGLYCERIDEMIA; IMMUNOSUPPRESSIVE TREATMENT; INTRAOPERATIVE PERIOD; LIVER CELL CARCINOMA; LIVER FUNCTION TEST; LIVER GRAFT REJECTION; LIVER TRANSPLANTATION; LIVING DONOR; LIVING DONOR LIVER TRANSPLANTATION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MYCOSIS; NAUSEA; NUTRITIONAL DISORDER; PHASE 4 CLINICAL TRIAL; PILOT STUDY; POSTOPERATIVE PERIOD; PRIORITY JOURNAL; SIDE EFFECT; SINUS BRADYCARDIA; SKIN DISEASE; SYSTOLIC BLOOD PRESSURE; TREMOR; VIRUS INFECTION;

ADMINISTRATION, ORAL; ADRENAL CORTEX HORMONES; ADULT; CAPSULES; CHI-SQUARE DISTRIBUTION; DRUG THERAPY, COMBINATION; FEMALE; GRAFT REJECTION; GRAFT SURVIVAL; HUMANS; IMMUNOSUPPRESSIVE AGENTS; LIVER FUNCTION TESTS; LIVER TRANSPLANTATION; LIVING DONORS; MALE; METHYLPREDNISOLONE; MIDDLE AGED; PILOT PROJECTS; REPUBLIC OF KOREA; TACROLIMUS; TIME FACTORS; TREATMENT OUTCOME;

EID: 84860590402     PISSN: 01726390     EISSN: None     Source Type: Journal    
DOI: 10.5754/hge11472     Document Type: Article

References (20)

1. Guleria S, Kamboj M, Chatterjee A, et al.: Generic tacrolimus (Pan Graf) in renal transplantation: an experience of 155 recipients in India. Transplant Proc 2008; 40:2237-2239.
2. Spencer CM, Goa KL, Gillis JC: Tacrolimus. An update of its pharmacology and clinical efficacy in the management of organ transplantation. Drugs 1997; 54:925-975. (Pubitemid 27526900)
3. Goto T, Kino T, Hatanaka H, et al.: FK 506: historical perspectives. Transplant Proc 1991; 23:2713-2717.
4. Kim SJ, Huh KH, Han DJ, et al.: A 6-month, multicenter, single-arm pilot study to evaluate the efficacy and safety of generic tacrolimus (TacroBell) after primary renal transplantation. Transplant Proc 2009; 41:1671-1674.
5. Mazzaferro V, Regalia E, Doci R, et al.: Liver transplantation for the treatment of small hepatocellular carcinomas in patients with cirrhosis. N Engl J Med 1996; 334:693-699. (Pubitemid 26079803)
6. Banff schema for grading liver allograft rejection: an international consensus document. Hepatology 1997; 25:658-663.
7. Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D: A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med 1999; 130:461-470. (Pubitemid 29135798)
8. 2003 European Society of Hypertension-European Society of Cardiology guidelines for the management of arterial hypertension. J Hypertens 2003; 21:1011-1053.
9. Webster A, Woodroffe RC, Taylor RS, Chapman JR, Craig JC: Tacrolimus versus cyclosporin as primary immunosuppression for kidney transplant recipients. Cochrane Database Syst Rev 2005; CD003961.
10. Petan JA, Undre N, First MR, et al.: Physiochemical properties of generic formulations of tacrolimus in Mexico. Transplant Proc 2008; 40:1439-1442. (Pubitemid 351853144)
11. Ramirez CB, Doria C, di Francesco F, Iaria M, Kang Y, Marino IR: Basiliximab induction in adult liver transplant recipients with 93% rejection-free patient and graft survival at 24 months. Transplant Proc 2006; 38:3633-3635. (Pubitemid 44908493)
12. Liu CL, Fan ST, Lo CM, Chan SC, Ng IO, Lai CL, Wong J. Interleukin-2 receptor antibody (basiliximab) for immunosuppressive induction therapy after liver transplantation: a protocol with early elimination of steroids and reduction of tacrolimus dosage. Liver Transpl 2004; 10:728-733. (Pubitemid 38787130)
13. Gruttadauria S, Cintorino D, Piazza T, M, Verzaro R, et al.: A safe immunosuppressive protocol in adult-to-adult living related liver transplantation. Transplant Proc 2006; 38:1106-1108.
14. Ziolkowski J, Paczek L, Niewczas M, et al.: Effect of immunosuppressive regimen on acute rejection and liver graft function. Transplant Proc 2003; 35:2281-2283. (Pubitemid 37194391)
15. Jain A, Kashyap R, Dodson F, et al.: A prospective randomized trial of tacrolimus and prednisone versus tacrolimus, prednisone and mycophenolate mofetil in primary adult liver transplantation: a single center report. Transplantation 2001; 72:1091-1097. (Pubitemid 32924083)
16. Wiesner RH, Shorr JS, Steffen BJ, Chu AH, Gordon RD, Lake JR: Mycophenolate mofetil combination therapy improves long-term outcomes after liver transplantation in patients with and without hepatitis C. Liver Transpl 2005; 11:750-759. (Pubitemid 40975576)
17. Reggiani P, Arru M, Regazzi M, et al.: A "steroid-free" tacrolimus and low-dose mycophenolate mofetil primary immunosuppression does not prevent early acute rejection after liver transplantation. Transplant Proc 2005; 37:1697-1699. (Pubitemid 40790800)
18. Alessiani M, Cillo U, Fung JJ, et al.: Adverse effects of FK 506 overdosage after liver transplantation. Transplant Proc 1993; 25:628-634. (Pubitemid 23082500)
19. Trotter JF, Stolpman N, Wachs M, et al.: Living donor liver transplant recipients achieve relatively higher immunosuppressant blood levels than cadaveric recipients. Liver Transpl 2002;8:212-218. (Pubitemid 34257202)
20. European FK506 Multicentre Liver Study Group: Randomised trial comparing tacrolimus (FK506) and cyclosporin in prevention of liver allograft rejection. Lancet 1994; 344:423-428.