A phase III study of belatacept versus cyclosporine in kidney transplants from extended criteria donors (BENEFIT-EXT Study)

American Journal of Transplantation

Volumn 10, Issue 3, 2010, Pages 547-557

  Durrbach, A ^a   Pestana, J M ^b   Pearson, T ^c   Vincenti, F ^d   Garcia, V D ^e   Campistol, J ^f   Del Carmen Rial, M ^g   Florman, S ^h   Block, A ⁱ   Di Russo, G ⁱ   Xing, J ⁱ   Garg, P ⁱ   Grinyo J ^j  

^a BICÊTRE HOSPITAL   (France)

^b HOSPITAL DO RIM E HIPERTENSÃO   (Brazil)

^c EMORY UNIVERSITY   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

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

^f HOSPITAL CLÍNIC   (Spain)

^g Instituto de Nefrologia Buenos Aires ar   (Argentina)

^h TULANE UNIVERSITY SCHOOL OF MEDICINE   (United States)

ⁱ BRISTOL MYERS SQUIBB   (United States)

^j HOSPITAL UNIVERSITARI DE BELLVITGE   (Spain)

more..

Author keywords

Belatacept; Cyclosporine; Extended criteria donor; Kidney; Renal function

Indexed keywords

BASILIXIMAB; BELATACEPT; CORTICOSTEROID DERIVATIVE; CYCLOSPORIN A; METHYLPREDNISOLONE; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; ABATACEPT; ANTIBODY CONJUGATE; CALCINEURIN INHIBITOR; CYCLOSPORIN; IMMUNOSUPPRESSIVE AGENT;

ACUTE GRAFT REJECTION; ADULT; ANEMIA; ARTICLE; BRONCHITIS; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE BLOOD LEVEL; CYTOMEGALOVIRUS INFECTION; DIARRHEA; DRUG EFFICACY; DRUG FEVER; DRUG SAFETY; DRUG WITHDRAWAL; ESCHERICHIA COLI INFECTION; FEMALE; GASTROENTERITIS; GLOMERULUS FILTRATION RATE; GRAFT DYSFUNCTION; GRAFT RECIPIENT; GRAFT REJECTION; GRAFT SURVIVAL; HUMAN; HYPERKALEMIA; HYPERTENSION; IMMUNOSUPPRESSIVE TREATMENT; KIDNEY FUNCTION; KIDNEY GRAFT; KIDNEY GRAFT REJECTION; KIDNEY STRUCTURE; LEUKOPENIA; LYMPHOCELE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; PHASE 3 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROGNOSIS; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; THRUSH; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; CARDIOVASCULAR DISEASES; KIDNEY; KIDNEY TRANSPLANTATION; MIDDLE AGED; PATHOLOGY; PROCEDURES; RISK;

ADULT; CALCINEURIN INHIBITORS; CARDIOVASCULAR DISEASES; CYCLOSPORINE; FEMALE; GRAFT REJECTION; GRAFT SURVIVAL; HUMANS; IMMUNOCONJUGATES; IMMUNOSUPPRESSIVE AGENTS; KIDNEY; KIDNEY TRANSPLANTATION; MALE; MIDDLE AGED; RISK;

EID: 76949090842     PISSN: 16006135     EISSN: 16006143     Source Type: Journal    
DOI: 10.1111/j.1600-6143.2010.03016.x     Document Type: Article

References (48)

1. Wolfe RA, Ashby VB, Milford EL et al. Comparison of mortality in all patients on dialysis, patients on dialysis awaiting transplantation, and recipients of a first cadaveric transplant. N Engl J Med 1999 341 : 1725 1730.
2. Overbeck I, Bartels M, Decker O, Harms J, Hauss J, Fangmann J. Changes in quality of life after renal transplantation. Transplant Proc 2005 37 : 1618 1621.
3. Port FK, Wolfe RA, Mauger EA, Berling DP, Jiang K. Comparison of survival probabilities for dialysis patients vs cadaveric renal transplant recipients. JAMA 1993 270 : 1339 1343.
4. United Network for Organ Sharing National Data. http://www.unos.org/. 2008. Accessed 11-15-2008.
5. 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.
6. Danovitch GM, Cohen DJ, Weir MR et al. Current status of kidney and pancreas transplantation in the United States, 1994-2003. Am J Transplant 2005 5 (4 Pt 2 904 915.
7. Metzger RA, Delmonico FL, Feng S, Port FK, Wynn JJ, Merion RM. Expanded criteria donors for kidney transplantation. Am J Transplant 2003 3 (Suppl 4 114 125.
8. Saidi RF, Elias N, Kawai T et al. Outcome of kidney transplantation using expanded criteria donors and donation after cardiac death kidneys: Realities and costs. Am J Transplant 2007 7 : 2769 2774.
9. Weimert NA, Alloway RR. Renal transplantation in high-risk patients. Drugs 2007 67 : 1603 1627.
10. Hariharan S, McBride MA, Cherikh WS, Tolleris CB, Bresnahan BA, Johnson CP transplant renal function in the first year predicts long-term kidney transplant survival. Kidney Int 2002 62 : 311 318.
11. 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.
12. 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.
13. Leichtman AB, Cohen D, Keith D et al. Kidney and pancreas transplantation in the United States, 1997-2006: The HRSA Breakthrough Collaboratives and the 58 DSA Challenge. Am J Transplant 2008 8 (4 Pt 2 946 957.
14. 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.
15. Vincenti F, Larsen C, Durrbach A et al. Costimulation blockade with belatacept in renal transplantation. N Engl J Med 2005 353 : 770 781.
16. Racusen LC, Solez K, Colvin RB et al. The Banff 97 working classification of renal allograft pathology. Kidney Int 1999 55 : 713 723. (Pubitemid 29082898)
17. Wilson DM, Bergert JH, Larson TS, Liedtke RR. GFR determined by nonradiolabeled iothalamate using capillary electrophoresis. Am J Kidney Dis 1997 30 : 646 652.
18. 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.
19. 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.
20. Koch DD, Gansky SA. Statistical considerations for multiplicity in confirmatory protocols. Drug Inf J 1996 30 : 523 534.
21. Medical and Statistical Review and Evaluation (tacrolimus). 1997. Silver Spring, MD, US Food and Drug Administration/Center for Drug Evaluation and Research.
22. Medical and Statistical Review and Evaluation (Mycophenolate Sodium Delayed-Release Tablets). 2004. Silver Spring, MD, US Food and Drug Administration/Center for Drug Evaluation and Research.
23. Halloran P, Mathew T, Tomlanovich S, Groth C, Hooftman L, Barker C. Mycophenolate mofetil in renal allograft recipients: A pooled efficacy analysis of three randomized, double-blind, clinical studies in prevention of rejection. The International Mycophenolate Mofetil Renal Transplant Study Groups. Transplantation 1997 63 : 39 47.
24. Sollinger H, Kaplan B, Pescovitz MD et al. Basiliximab versus antithymocyte globulin for prevention of acute renal allograft rejection. Transplantation 2001 72 : 1915 1919.
25. Vincenti F, Ramos E, Brattstrom C et al. Multicenter trial exploring calcineurin inhibitors avoidance in renal transplantation. Transplantation 2001 71 : 1282 1287.
26. 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)
27. Furian L, Baldan N, Margani G et al. Calcineurin inhibitor-free immunosuppression in dual kidney transplantation from elderly donors. Clin Transplant 2007 21 : 57 62.
28. Diekmann F, Campistol JM, Saval N et al. Sequential quadruple immunosuppression including sirolimus in extended criteria and nonheartbeating donor kidney transplantation. Transplantation 2007 84 : 429 432.
29. Cruzado JM, Bestard O, Riera L et al. Immunosuppression for dual kidney transplantation with marginal organs: The old is better yet. Am J Transplant 2007 7 : 639 644.
30. Berber I, Aydin C, Yigit B et al. Blood pressure and graft outcome in renal transplantation. Transplant Proc 2005 37 : 997 998.
31. Porrini E, Delgado P, Bigo C et al. Impact of metabolic syndrome on graft function and survival after cadaveric renal transplantation. Am J Kidney Dis 2006 48 : 134 142.
32. Ortiz F, Paavonen T, Tornroth T et al. Predictors of renal allograft histologic damage progression. J Am Soc Nephrol 2005 16 : 817 824.
33. Ojo AO. Cardiovascular complications after renal transplantation and their prevention. Transplantation 2006 82 : 603 611.
34. Kasiske BL, Anjum S, Shah R et al. Hypertension after kidney transplantation. Am J Kidney Dis 2004 43 : 1071 1081.
35. Hsia SH, Pan D, Berookim P, Lee ML. A population-based, cross-sectional comparison of lipid-related indexes for symptoms of atherosclerotic disease. Am J Cardiol 2006 98 : 1047 1052.
36. Bansal S, Buring JE, Rifai N, Mora S, Sacks FM, Ridker PM. Fasting compared with nonfasting triglycerides and risk of cardiovascular events in women. JAMA 2007 298 : 309 316.
37. Nordestgaard BG, Benn M, Schnohr P, Tybjaerg-Hansen A. Nonfasting triglycerides and risk of myocardial infarction, ischemic heart disease, and death in men and women. JAMA 2007 298 : 299 308.
38. Jordan ML, Cook GT, Cardella CJ. Ten years of experience with vascular complications in renal transplantation. J Urol 1982 128 : 689 692.
39. Morrissey PE, Ramirez PJ, Gohh RY et al. Management of thrombophilia in renal transplant patients. Am J Transplant 2002 2 : 872 876.
40. Caillard S, Lelong C, Pessione F, Moulin B. Post-transplant lymphoproliferative disorders occurring after renal transplantation in adults: Report of 230 cases from the French Registry. Am J Transplant 2006 6 : 2735 2742.
41. Penn I, Porat G. Central nervous system lymphomas in organ allograft recipients. Transplantation 1995 59 : 240 244.
42. Faull RJ, Hollett P, McDonald SP. Lymphoproliferative disease after renal transplantation in Australia and New Zealand. Transplantation 2005 80 : 193 197.
43. Libertiny G, Watson CJ, Gray DW, Welsh KI, Morris PJ. Rising incidence of post-transplant lymphoproliferative disease in kidney transplant recipients. Br J Surg 2001 88 : 1330 1334.
44. Opelz G, Dohler B. Lymphomas after solid organ transplantation: A collaborative transplant study report. Am J Transplant 2004 4 : 222 230.
45. Manez R, Breinig MC, Linden P et al. Posttransplant lymphoproliferative disease in primary Epstein-Barr virus infection after liver transplantation: The role of cytomegalovirus disease. J Infect Dis 1997 176 : 1462 1467.
46. Opelz G, Daniel V, Naujokat C, Fickenscher H, Dohler B. Effect of cytomegalovirus prophylaxis with immunoglobulin or with antiviral drugs on post-transplant -Hodgkin lymphoma: A multicentre retrospective analysis. Lancet Oncol 2007 8 : 212 218.
47. Larsen C, Charpentier B, Grinyo J et al. One year safety profile of belatacept in kidney transplant patients from the BENEFIT and BENEFIT-EXT studies. Am J Transplant 2009 9 (Suppl 2 495.
48. Walker RC. Pretransplant assessment of the risk for posttransplant lymphoproliferative disorder. Transplant Proc 1995 27 (5 Suppl 1 41.