Three-year outcomes from BENEFIT, a randomized, active-controlled, parallel-group study in adult kidney transplant recipients

American Journal of Transplantation

Volumn 12, Issue 1, 2012, Pages 210-217

  Vincenti, F ^a   Larsen, C P ^b   Alberu, J ^c   Bresnahan, B ^d   Garcia, V D ^e   Kothari, J ^f   Lang, P ^g   Urrea, E Mancilla ^h   Massari, P ⁱ   Mondragon Ramirez, G ^j   Reyes Acevedo, R ^k   Rice, K ^l   Rostaing, L ^m   Steinberg, S ⁿ   Xing, J ^o   Agarwal, M ^o   Harler, M B ^o   Charpentier, B ^p  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b EMORY UNIVERSITY   (United States)

^c INSTITUTO NACIONAL DE CIENCIAS MÉDICAS Y NUTRICIÓN SALVADOR ZUBIRÁN   (Mexico)

^d MEDICAL COLLEGE OF WISCONSIN   (United States)

^e Hospital Dom Vicente Scherer Complexo Hospitalar Santa Casa   (Brazil)

^f P D HINDUJA NATIONAL HOSPITAL   (India)

^g HENRI MONDOR HOSPITAL   (France)

^h INSTITUTO NACIONAL DE CARDIOLOGÍA IGNACIO CHÁVEZ   (Mexico)

ⁱ HOSPITAL PRIVADO   (Argentina)

^j Instituto Mexicano de Transplantes   (Mexico)

^k Hospital Miguel Hidalgo de Aguascalientes   (Mexico)

^l BAYLOR UNIVERSITY MEDICAL CENTER   (United States)

^m TOULOUSE UNIVERSITY HOSPITAL   (France)

ⁿ SHARP MEMORIAL HOSPITAL   (United States)

^o BRISTOL MYERS SQUIBB   (United States)

^p INSERM U1014   (France)

more..

Author keywords

Belatacept; cyclosporine; kidney; renal function

Indexed keywords

BELATACEPT; CYCLOSPORIN;

ARTICLE; BASAL CELL CARCINOMA; BOWEN DISEASE; BREAST CANCER; CHRONIC KIDNEY DISEASE; CONTROLLED STUDY; CYTOMEGALOVIRUS INFECTION; DRUG EFFICACY; DRUG SAFETY; GLOMERULUS FILTRATION RATE; GRAFT SURVIVAL; HERPES ORALIS; HERPES SIMPLEX; HERPES ZOSTER; HUMAN; KIDNEY CARCINOMA; KIDNEY FUNCTION; KIDNEY GRAFT; KIDNEY GRAFT REJECTION; KIDNEY TRANSPLANTATION; LYMPHOPROLIFERATIVE DISEASE; MAJOR CLINICAL STUDY; ONYCHOMYCOSIS; POLYOMAVIRUS INFECTION; POSTOPERATIVE COMPLICATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); SKIN CARCINOMA; SQUAMOUS CELL CARCINOMA; SURVIVAL RATE; THRUSH; THYROID CANCER; TINEA CORPORIS; TREATMENT OUTCOME; TUBERCULOSIS;

ADULT; GLOMERULAR FILTRATION RATE; HUMANS; KIDNEY TRANSPLANTATION; TREATMENT OUTCOME;

EID: 84855939763     PISSN: 16006135     EISSN: 16006143     Source Type: Journal    
DOI: 10.1111/j.1600-6143.2011.03785.x     Document Type: Article

References (39)

1. Fellstrom B, Jardine AG, Soveri, I, et al,. Renal dysfunction as a risk factor for mortality and cardiovascular disease in renal transplantation: Experience from the Assessment of Lescol in Renal Transplantation trial. Transplantation 2005; 79: 1160-1163. (Pubitemid 40664016)
2. Fellstrom B, Jardine AG, Soveri, I, et al,. Renal dysfunction is a strong and independent risk factor for mortality and cardiovascular complications in renal transplantation. Am J Transplant 2005; 5: 1986-1991. (Pubitemid 41039875)
3. Meier-Kriesche HU, Baliga R, Kaplan B,. Decreased renal function is a strong risk factor for cardiovascular death after renal transplantation. Transplantation 2003; 75: 1291-1295. (Pubitemid 36513036)
4. Hariharan S, McBride MA, Cherikh WS, Tolleris CB, Bresnahan BA, Johnson CP,. Posttransplant renal function in the first year predicts long-term kidney transplant survival. Kidney Int 2002; 62: 311-318. (Pubitemid 34754077)
5. United Network for Organ Sharing National Data. 2011. Accessed 1-15-2011.
6. Gaston RS,. Chronic calcineurin inhibitor nephrotoxicity: Reflections on an evolving paradigm. Clin J Am Soc Nephrol 2009; 4: 2029-2034.
7. Nankivell BJ, Borrows RJ, Fung CL, O'Connell PJ, Allen RD, Chapman JR,. The natural history of chronic allograft nephropathy. N Engl J Med 2003; 349: 2326-2333. (Pubitemid 37509740)
8. Opelz G, Dohler B,. Influence of immunosuppressive regimens on graft survival and secondary outcomes after kidney transplantation. Transplantation 2009; 87: 795-802.
9. Kreis H, Oberbauer R, Campistol, JM, et al,. Long-term benefits with sirolimus-based therapy after early cyclosporine withdrawal. J Am Soc Nephrol 2004; 15: 809-817. (Pubitemid 38294812)
10. Lebranchu Y, Thierry A, Toupance O, et al,. Efficacy on renal function of early conversion from cyclosporine to sirolimus 3 months after renal transplantation: Concept study. Am J Transplant 2009; 9: 1115-1123.
11. Ekberg H, Tedesco-Silva H, Demirbas A, et al,. Reduced exposure to calcineurin inhibitors in renal transplantation. N Engl J Med 2007; 357: 2562-2575. (Pubitemid 350294223)
12. Vincenti F, Ramos E, Brattstrom C, et al,. Multicenter trial exploring calcineurin inhibitors avoidance in renal transplantation. Transplantation 2001; 71: 1282-1287. (Pubitemid 32507148)
13. Ekberg H, Bernasconi C, Tedesco-Silva H, et al,. Calcineurin inhibitor minimization in the Symphony study: Observational results 3 years after transplantation. Am J Transplant 2009; 9: 1876-1885.
14. 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: 2522-2531. (Pubitemid 47561618)
15. 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: 514-522. (Pubitemid 43382137)
16. Halloran PF, de Freitas DG, Einecke G, et al,. An integrated view of molecular changes, histopathology and outcomes in kidney transplants. Am J Transplant 2010; 10: 2223-2230.
17. Pinsky BW, Takemoto SK, Lentine KL, Burroughs TE, Schnitzler MA, Salvalaggio PR,. Transplant outcomes and economic costs associated with patient noncompliance to immunosuppression. Am J Transplant 2009; 9: 2597-2606.
18. Ichimaru N, Kakuta Y, Abe T, et al,. Treatment adherence in renal transplant recipients: A questionnaire survey on immunosuppressants. Transplant Proc 2008; 40: 1362-1365. (Pubitemid 351853200)
19. Larsen CP, Pearson TC, Adams AB, et al,. Rational development of LEA29Y (belatacept), a high-affinity variant of CTLA4-Ig with potent immunosuppressive properties. Am J Transplant 2005; 5: 443-453. (Pubitemid 40313335)
20. Durrbach A, Pestana JM, Pearson T, et al,. A phase III study of belatacept versus cyclosporine in kidney transplants from extended criteria donors (BENEFIT-EXT study). Am J Transplant 2010; 10: 547-557.
21. Vincenti F, Charpentier B, Vanrenterghem Y, et al,. A phase III study of belatacept-based immunosuppression regimens versus cyclosporine in renal transplant recipients (BENEFIT study). Am J Transplant 2010; 10: 535-546.
22. Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D,; 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. (Pubitemid 29135798)
23. Levey AS, Coresh J, Greene T, et al,. Expressing the MDRD study equation for estimating GFR with IDMS traceable (gold standard) serum creatinine values. J Am Soc Nephrol 2005; 16: 69A.
24. National Kidney Foundation. KDOQI Clinical Practice Guidelines for Chronic Kidney Disease: Evaluation, Classification, and Stratification. 2002. Accessed November 10, 2010.
25. United States Renal Data System. USRDS 2010 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States. 2010. Bethesda, MD: National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases.
26. Larsen CP, Grinyo J, Medina-Pestana J, et al,. Belatacept-based regimens versus a cyclosporine a-based regimen in kidney transplant recipients: 2-year results from the BENEFIT and BENEFIT-EXT studies. Transplantation 2010; 90: 1528-1535.
27. Vincenti F, Blancho G, Durrbach A, et al,. Five-year results of a phase II study with belatacept in renal transplantation. J Am Soc Nephrol 2010; 21: 1587-1596.
28. Naesens M, Kuypers DR, Sarwal M,. Calcineurin inhibitor nephrotoxicity. Clin J Am Soc Nephrol 2009; 4: 481-508.
29. Gera M, Slezak JM, Rule AD, Larson TS, Stegall MD, Cosio FG,. Assessment of changes in kidney allograft function using creatinine-based estimates of glomerular filtration rate. Am J Transplant 2007; 7: 880-887. (Pubitemid 46481182)
30. Gill JS, Tonelli M, Mix CH, Pereira BJ,. The change in allograft function among long-term kidney transplant recipients. J Am Soc Nephrol 2003; 14: 1636-1642. (Pubitemid 36687067)
31. Gill JS, Tonelli M, Mix CH, Johnson N, Pereira BJ,. The effect of maintenance immunosuppression medication on the change in kidney allograft function. Kidney Int 2004; 65: 692-699. (Pubitemid 38130667)
32. Marcen R, Morales JM, Fernandez-Rodriguez A, et al,. Long-term graft function changes in kidney transplant recipients. NDT Plus 2010; 3 (Suppl-2): ii2-ii8.
33. Srinivas TR, Flechner SM, Poggio ED, et al,. Glomerular filtration rate slopes have significantly improved among renal transplants in the United States. Transplantation 2010; 90: 1499-1505.
34. Wu J, Li H, Huang H, et al,. Slope of changes in renal function in the first year posttransplantation and one-yr estimated glomerular filtration rate together predict long-term renal allograft survival. Clin Transplant 2010; 24: 862-868.
35. Schnitzler MA, Kalsekar A, You M, L'Italien G,. Expected median graft survival prediction for belatacept phase III trial outcomes in kidney transplantation. Am J Transplant 2011; 11 (S2): 353-354.
36. McFarlane PA,. Should patients remain on intensive hemodialysis rather than choosing to receive a kidney transplant? Semin Dial 2010; 23: 516-519.
37. Rao PS, Schaubel DE, Jia X, Li S, Port FK, Saran R,. Survival on dialysis post-kidney transplant failure: Results from the Scientific Registry of Transplant Recipients. Am J Kidney Dis 2007; 49: 294-300. (Pubitemid 46178401)
38. Grinyo J, Charpentier B, Pestana JM, et al,. An integrated safety profile analysis of belatacept in kidney transplant recipients. Transplantation 2010; 90: 1521-1527.
39. Faull RJ, Hollett P, McDonald SP,. Lymphoproliferative disease after renal transplantation in Australia and New Zealand. Transplantation 2005; 80: 193-197. (Pubitemid 41061675)