A randomized, open-label study of sirolimus versus cyclosporine in primary de novo renal allograft recipients

Transplantation

Volumn 95, Issue 10, 2013, Pages 1233-1241

  Flechner, Stuart M ^a   Gurkan, Alihan ^b,c   Hartmann, Anders ^d   Legendre, Christophe M ^e   Russ, Graeme R ^f   Campistol, Josep M ^g   Schena, Francesco P ^h   Hahn, Carolyn M ⁱ   Li, Huihua ⁱ   Korth Bradley, Joan M ⁱ   Tai, Sandi See ⁱ   Schulman, Seth L ⁱ  

^a CLEVELAND CLINIC LERNER COLLEGE OF MEDICINE   (United States)

^b ACIBADEM UNIVERSITY   (Turkey)

^c AKDENIZ UNIVERSITY   (Turkey)

^d OSLO UNIVERSITY HOSPITAL   (Norway)

^e UNIVERSITÉ PARIS DESCARTES   (France)

^f QUEEN ELIZABETH HOSPITAL   (Australia)

^g HOSPITAL CLÍNIC   (Spain)

^h UNIVERSITY OF BARI   (Italy)

ⁱ PFIZER INC   (United States)

Author keywords

Acute allograft rejection; Cyclosporine; Delayed graft function; Mycophenolate mofetil; Sirolimus

Indexed keywords

BASILIXIMAB; CYCLOSPORIN; METHYLPREDNISOLONE; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; RAPAMYCIN;

ACNE; ACUTE GRAFT REJECTION; ADULT; ALBUMINURIA; ANEMIA; ARTICLE; COMPARATIVE STUDY; CONSTIPATION; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DELAYED GRAFT FUNCTION; DERMATOMYCOSIS; DIARRHEA; DISEASE ASSOCIATION; DISEASE COURSE; DRUG BLOOD LEVEL; DRUG DOSE REDUCTION; DRUG FEVER; DRUG INDUCED HEADACHE; DRUG WITHDRAWAL; DYSURIA; FEMALE; FOLLOW UP; GLOMERULUS FILTRATION RATE; GRAFT RECIPIENT; GRAFT SURVIVAL; HEMATURIA; HERPES SIMPLEX; HUMAN; HUMAN TISSUE; HYPERCHOLESTEROLEMIA; HYPERGLYCEMIA; HYPERLIPIDEMIA; HYPERTENSION; HYPOKALEMIA; HYPOPHOSPHATEMIA; IMMUNOSUPPRESSIVE TREATMENT; INCIDENCE; INFECTIOUS COMPLICATION; KIDNEY ALLOGRAFT; KIDNEY ALLOGRAFT REJECTION; KIDNEY BIOPSY; KIDNEY FUNCTION; KIDNEY TUBULE NECROSIS; LACTATE DEHYDROGENASE BLOOD LEVEL; LEUKOPENIA; LIVER FUNCTION TEST; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MORTALITY; NAUSEA; OPEN STUDY; PAIN; PARALLEL DESIGN; PERIPHERAL EDEMA; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEPSIS; SIDE EFFECT; SURVIVAL RATE; THROMBOCYTOPENIA; THRUSH; TREATMENT DURATION; TREATMENT OUTCOME; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; VAGINITIS; VOMITING; WOUND HEALING;

ADULT; CYCLOSPORINE; DELAYED GRAFT FUNCTION; FEMALE; GLOMERULAR FILTRATION RATE; GRAFT REJECTION; GRAFT SURVIVAL; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; MALE; SIROLIMUS; TRANSPLANTATION, HOMOLOGOUS;

EID: 84878569533     PISSN: 00411337     EISSN: None     Source Type: Journal    
DOI: 10.1097/TP.0b013e318291a269     Document Type: Article

References (25)

1. Ciancio G, Burke GW, Suzart K, et al. Daclizumab induction, tacrolimus, mycophenolate mofetil and steroids as an immunosuppression regimen for primary kidney transplant recipients. Transplantation 2002; 73: 1100.
2. Nankivell BJ, Borrows RJ, Fung CL, et al. The natural history of chronic allograft nephropathy. N Engl J Med 2003; 349: 2326.
3. Naesens M, Kuypers DR, Sarwal M. Calcineurin inhibitor nephrotoxicity. Clin J Am Soc Nephrol 2009; 4: 481.
4. Rapamune [Package Insert]. Philadelphia, PA: Wyeth Pharmaceuticals; 2011.
5. Flechner SM, Goldfarb D, Modlin C, et al. Kidney transplantation without calcineurin inhibitor drugs: a prospective, randomized trial of sirolimus versus cyclosporine. Transplantation 2002; 74: 1070.
6. Martinez-Mier G, Mendez-Lopez MT, Estrada-Oros J, et al. Conversion from calcineurin inhibitor to sirolimus for renal function deterioration in kidney allograft recipients. Arch Med Res 2006; 37: 635.
7. Buchler M, Caillard S, Barbier S, et al. Sirolimus versus cyclosporine in kidney recipients receiving thymoglobulin, mycophenolate mofetil and a 6-month course of steroids. Am J Transplant 2007; 7: 2522.
8. Flechner SM, Goldfarb D, Solez K, et al. Kidney transplantation with sirolimus and mycophenolate mofetil-based immunosuppression: 5-year results of a randomized prospective trial compared to calcineurin inhibitor drugs. Transplantation 2007; 83: 883.
9. Hamdy AF, Bakr MA, Ghoneim MA. Long-term efficacy and safety of a calcineurin inhibitor-free regimen in live-donor renal transplant recipients. J Am Soc Nephrol 2008; 19: 1225.
10. Glotz D, Charpentier B, Abramovicz D, et al. Thymoglobulin induction and sirolimus versus tacrolimus in kidney transplant recipients receiving mycophenolate mofetil and steroids. Transplantation 2010; 89: 1511.
11. Schena FP, Pascoe MD, Alberu J, et al. Conversion from calcineurin inhibitors to sirolimus maintenance therapy in renal allograft recipients: 24-month efficacy and safety results from the CONVERT trial. Transplantation 2009; 87: 233.
12. Flechner SM, Glyda M, Cockfield S, et al. The ORION study: comparison of two sirolimus-based regimens versus tacrolimus and mycophenolate mofetil in renal allograft recipients. Am J Transplant 2011; 11: 1633.
13. McTaggart RA, Tomlanovich S, Bostrom A, et al. Comparison of outcomes after delayed graft function: sirolimus-based versus other calcineurin-inhibitor sparing induction immunosuppression regimens. Transplantation 2004; 78: 475.
14. McTaggart RA, Gottlieb D, Brooks J, et al. Sirolimus prolongs recovery from delayed graft function after cadaveric renal transplantation. Am J Transplant 2003; 3: 416.
15. Simon JF, Swanson SJ, Agodoa LY, et al. Induction sirolimus and delayed graft function after deceased donor kidney transplantation in the United States. Am J Nephrol 2004; 24: 393.
16. Lebranchu Y, Thierry A, Thervet E, et al. Efficacy and safety of early cyclosporine conversion to sirolimus with continued MMFVfour-year results of the postconcept study. Am J Transplant 2011; 11: 1665.
17. 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.
18. Abramowicz D, Manas D, Lao M, et al. Cyclosporine withdrawal from a mycophenolate mofetil-containing immunosuppressive regimen in stable kidney transplant recipients: a randomized, controlled study. Transplantation 2002; 74: 1725.
19. Hazzan M, Labalette M, Copin MC, et al. Predictive factors of acute rejection after early cyclosporine withdrawal in renal transplant recipients who receive mycophenolate mofetil: results from a prospective, randomized trial. J Am Soc Nephrol 2005; 16: 2509.
20. Ekberg H, Grinyo J, Nashan B, et al. Cyclosporine sparing with mycophenolate mofetil, daclizumab and corticosteroids in renal allograft recipients: the CAESAR Study. Am J Transplant 2007; 7: 560.
21. Larson TS, Dean PG, Stegall MD, et al. Complete avoidance of calcineurin inhibitors in renal transplantation: a randomized trial comparing sirolimus and tacrolimus. Am J Transplant 2006; 6: 514.
22. Lo A, Egidi MF, Gaber LW, et al. Comparison of sirolimus-based calcineurin inhibitor-sparing and calcineurin inhibitor-free regimens in cadaveric renal transplantation. Transplantation 2004; 77: 1228.
23. Hamdy AF, El-Agroudy AE, Bakr MA, et al. Comparison of sirolimus with low-dose tacrolimus versus sirolimus-based calcineurin inhibitorfree regimen in live donor renal transplantation. Am J Transplant 2005; 5: 2531.
24. Ekberg H, Tedesco-Silva H, Demirbas A, et al. Reduced exposure to calcineurin inhibitors in renal transplantation. N Engl J Med 2007; 357: 2562.
25. Vincenti F, Charpentier B, VanrenterghemY, et al. A phase III study of belatacept-based immunosuppression regimens versus cyclosporine in renal transplant recipients (BENEFIT study). Am J Transplant 2010; 10: 535.