One-year results with extended-release tacrolimus/MMF, tacrolimus/MMF and cyclosporine/MMF in de novo kidney transplant recipients

American Journal of Transplantation

Volumn 7, Issue 3, 2007, Pages 595-608

  Silva Jr , H T ^a   Yang, H C ^b   Abouljoud, M ^c   Kuo, P C ^d   Wisemandle, K ^e   Bhattacharya, P ^e   Dhadda, S ^e   Holman, J ^e   Fitzsimmons, W ^e   Roy First, M ^e  

^a HOSPITAL DO RIM E HIPERTENSÃO   (Brazil)

^b Pinnacle Health System   (United States)

^c HENRY FORD HOSPITAL   (United States)

^d DUKE UNIVERSITY MEDICAL CENTER   (United States)

^e ASTELLAS PHARMA GLOBAL DEVELOPMENT   (United States)

Author keywords

De novo kidney transplantation; Tacrolimus

Indexed keywords

ANTILIPEMIC AGENT; BASILIXIMAB; CORTICOSTEROID; CYCLOSPORIN A; INSULIN; LYMPHOCYTE ANTIBODY; METHYLPREDNISOLONE; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; ORAL ANTIDIABETIC AGENT; RAPAMYCIN; TACROLIMUS; THYMOCYTE ANTIBODY;

ACUTE GRAFT REJECTION; ADOLESCENT; ADULT; AGED; ALOPECIA; ARTERIOVENOUS FISTULA; ARTICLE; BACTERIAL INFECTION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYTOMEGALOVIRUS INFECTION; DIABETES MELLITUS; DIARRHEA; DISORDERS OF CARBOHYDRATE METABOLISM; DRUG DOSAGE FORM COMPARISON; DRUG DOSE REDUCTION; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG FORMULATION; DRUG SAFETY; DRUG SUBSTITUTION; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; GASTROENTERITIS; GINGIVA HYPERPLASIA; GRAFT FAILURE; GRAFT RECIPIENT; GRAFT SURVIVAL; HIRSUTISM; HUMAN; HYDRONEPHROSIS; HYPERLIPIDEMIA; HYPERTRICHOSIS; HYPONATREMIA; INSOMNIA; KIDNEY BIOPSY; KIDNEY DISEASE; KIDNEY GRAFT; KIDNEY GRAFT REJECTION; KIDNEY TRANSPLANTATION; LOOSE FECES; LYMPHOCELE; MAJOR CLINICAL STUDY; MALE; MICROEMULSION; MULTICENTER STUDY; MYCOSIS; NEPHROTOXICITY; ORTHOSTATIC HYPOTENSION; PARESTHESIA; PERIPHERAL EDEMA; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROSTATE HYPERTROPHY; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINUSITIS; SURVIVAL RATE; SUSTAINED DRUG RELEASE; TREATMENT OUTCOME; TREATMENT RESPONSE; TREMOR; VIREMIA; VIRUS INFECTION; VISUAL ACUITY;

ADOLESCENT; ADULT; AGED; CYCLOSPORINE; FEMALE; GRAFT REJECTION; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; MALE; MIDDLE AGED; MYCOPHENOLIC ACID; SIROLIMUS; TACROLIMUS; TREATMENT OUTCOME;

EID: 33847758317     PISSN: 16006135     EISSN: 16006143     Source Type: Journal    
DOI: 10.1111/j.1600-6143.2007.01661.x     Document Type: Article

References (25)

1. Artz MA, Boots JMM, Ligtenberg G et al. Improved cardiovascular risk profile and renal function in renal transplant patients after randomized conversion from cyclosporine to tacrolimus. J Am Soc Nephrol 2003; 14: 1880-1888.
2. Vincenti F, Jensik SC, Filo RS, Miller J, Pirsch J. A long-term comparison of tacrolimus (FK506) and cyclosporine in kidney transplantation: Evidence for improved allograft survival at five years. Transplantation 2002; 73: 775-782.
3. Johnson C, Ahsan N, Gonwa T et al. Randomized trial of tacrolimus (Prograf) in combination with azathioprine or mycophenolate mofetil versus cyclosporine (Neoral) with mycophenolate mofetil after cadaveric kidney transplantation. Transplantation 2000; 69: 834-841.
4. Pirsch JD, Miller J, Deierhoi MH, Vincenti F, Filo RS for the FK506 Kidney Transplant Study Group. A comparison of tacrolimus (FK506) and cyclosporine for immunosuppression after cadaveric renal transplantation. Transplantation 1997; 63: 977-983.
5. Webster AC, Woodroffe R, Taylor RS, Chapman JR, Craig JC. Tacrolimus versus cyclosporin as primary immunosuppression for kidney transplant recipients: Meta-analysis and metaregression of randomized trial data. Br Med J 2005;331: 810-814.
6. Heisel O, Heisel R, Balshaw R, Keown P. New onset diabetes mellitus in patients receiving calcineurin inhibitors: A systemic review and meta-analysis. Am J Transplant 2004;4: 583-595.
7. Knoll GA, Bell RC. Tacrolimus versus cyclosporin for immunosuppression in renal transplantation: Meta-analysis of randomized trials. Br Med J 1999;318: 1104-1107.
8. Gonwa T, Johnson C, Ahsan N et al. Randomized trial of tacrolimus + mycophenolate mofetil or azathioprine versus cyclosporine + mycophenolate mofetil after cadaveric kidney transplantation: Results at three years. Transplantation 2003;75: 2048-2053.
9. Didlake RH, Dreyfus K, Kerman RH, Van Buren CT, Kahan BD. Patient noncompliance: A major cause of late graft failure in cyclosporine-treated renal transplants. Transplant Proc 1988;20: 63-69.
10. Weng FL, Israni AK, Joffe MM et al. Race and electronically measured adherence to immunosuppressive medications after deceased donor renal transplantation. J Am Soc Nephrol 2005;16: 1839-1848.
11. Neylan JF. Immunosuppressive therapy in high-risk transplant patients: Dose-dependent efficacy of mycophenolate mofetil in African-American renal allograft recipients. Transplantation 1997; 64: 1277-1282.
12. Racusen LC, Solez K, Colvin RB et al. The Banff 97 working classification of renal allograft pathology. Kidney Int 1999; 55: 713-723.
13. Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D for the Modification of Diet in Renal Disease Study Group. A more accurate method to estimate glomerular filtration rate from serum creatinine: A new prediction equation. Ann Intern Med 1999; 130: 461-470.
14. Fitzsimmons WE, Bekersky I, Dressler D, Raye K, Hodosh E, Mekki Q. Demographic considerations in tacrolimus pharmacokinetics. Transplant Proc 1998; 30: 1359-1364.
15. Trofe J, Gordon J, Roy-Chaudhury P et al. Polyomavirus nephropathy in kidney transplantation. Prog Transplant 2004; 14: 130-140.
16. Alloway R, Steinberg S, Khalil K et al. Conversion of stable kidney transplant recipients from a twice daily Prograf-based regimen to a once daily modified release tacrolimus-based regimen. Transplant Proc 2005; 37: 867-870.
17. Ihara H, Shinkuma D, Ichikawa Y, Nojima M, Nagano S, Ikoma F. Intra- and inter-individual variation in the pharmacokinetics of tacrolimus (FK506) in kidney transplant recipients-Importance of trough level as a practical indicator. Int J Urol 1995; 2: 151-155.
18. Borrows R, Chusney G, Loucaidou M et al. Mycophenolic acid 12-h trough level monitoring in renal transplantation: Association with acute rejection and toxicity. Am J Transplant 2006; 6: 121-128.
19. Zucker K, Rosen A, Tsaroucha A et al. Augmentation of mycophenolate mofetil pharmacokinetics in renal transplant patients receiving Prograf and Cellcept [sp] in Combination Therapy. Transplant Proc 1997; 29: 334-336.
20. van Hest RM, Mathot RAA, Pescovitz MD, Gordon R, Mamelok RD, Van Gelder T. Explaining variability in mycophenolic acid exposure to optimize mycophenolate mofetil dosing: A population pharmacokinetic meta-analysis of mycophenolic acid in renal transplant recipients. J Am Soc Nephrol 2006; 17: 871-880.
21. van Gelder T, Meur YL, Shaw LM et al. Therapeutic drug monitoring of mycophenolate mofetil in transplantation. Ther Drug Monit 2006; 28: 145-154.
22. Mourad M, Malaise J, Eddour DC et al. Correlation of mycophenolic acid pharmacokinetic parameters with side effects in kidney transplant patients treated with mycophenolate mofetil. Clin Chem 2001; 47: 88-94.
23. Mourad M, Malaise J, Eddour DC et al. Pharmacokinetic basis for the efficient and safe use of low-dose mycophenolate mofetil in combination with tacrolimus in kidney transplantation. Clin Chem 2001; 47: 1241-1248.
24. Gonwa T, Mendez R, Yang HC,Weinstein S, Jensik S, Steinberg S, for the Prograf Study Group. Randomized trial of tacrolimus in combination with sirolimus or mycophenolate mofetil in kidney transplantation: Results at 6 months. Transplantation 2003; 75: 1213-1220.
25. Miller J, Mendez R, Pirsch JD, Jensik SC for the FK506/MMF Dose-Ranging Kidney Transplant Study Group. Safety and efficacy of tacrolimus in combination with mycophenolate mofetil (MMF) in cadaveric renal transplant recipients. Transplantation 2000; 69: 875-880.