Randomized trial of single-dose versus divided-dose rabbit anti-thymocyte globulin induction in renal transplantation: an interim report

Transplantation

Volumn 85, Issue 10, 2008, Pages 1391-1399

  Stevens, R Brian ^a   Mercer, David F ^a   Grant, Wendy J ^a   Freifeld, Alison G ^a   Lane, James T ^a   Groggel, Gerald C ^a   Rigley, Theodore H ^a   Nielsen, Kathleen J ^a   Henning, Megan E ^a   Skorupa, Jill Y ^a   Skorupa, Anna J ^a   Christensen, Kecia A ^a   Sandoz, John P ^b   Kellogg, Anna M ^a   Langnas, Alan N ^a   Wrenshall, Lucile E ^a  

^a UNIVERSITY OF NEBRASKA MEDICAL CENTER   (United States)

^b Sigma Analytics   (United States)

Author keywords

Rabbit Anti thymocyte globulin; Renal allograft function; Renal Transplantation

Indexed keywords

METHYLPREDNISOLONE; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; RAPAMYCIN; TACROLIMUS; THYMOCYTE ANTIBODY; LYMPHOCYTE ANTIBODY;

ADULT; ARTICLE; CHRONIC ALLOGRAFT NEPHROPATHY; CLINICAL ASSESSMENT; CLINICAL PROTOCOL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSAGE SCHEDULE COMPARISON; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; FEMALE; FOLLOW UP; GLOMERULUS FILTRATION RATE; GRAFT RECIPIENT; GRAFT SURVIVAL; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; KIDNEY BIOPSY; KIDNEY FUNCTION; KIDNEY GRAFT; KIDNEY TRANSPLANTATION; LABORATORY DIAGNOSIS; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; THROMBOCYTE COUNT; TREATMENT OUTCOME; ALLOTRANSPLANTATION; ANIMAL; DRUG ADMINISTRATION; DRUG COMBINATION; DRUG EFFECT; DRUG MONITORING; IMMUNOLOGY; METHODOLOGY; MIDDLE AGED; MORTALITY; PATIENT SELECTION; RABBIT; SURVIVAL;

ADULT; ANIMALS; ANTILYMPHOCYTE SERUM; DRUG ADMINISTRATION SCHEDULE; DRUG MONITORING; DRUG THERAPY, COMBINATION; FEMALE; GLOMERULAR FILTRATION RATE; GRAFT SURVIVAL; HUMANS; KIDNEY TRANSPLANTATION; MALE; MIDDLE AGED; PATIENT SELECTION; RABBITS; SIROLIMUS; SURVIVAL ANALYSIS; TACROLIMUS; TRANSPLANTATION, HOMOLOGOUS;

EID: 48649088099     PISSN: 00411337     EISSN: None     Source Type: Journal    
DOI: 10.1097/TP.0b013e3181722fad     Document Type: Article

References (40)

1. Halloran PF. Call for revolution: A new approach to describing allograft deterioration. Am J Transplant 2002; 2: 195.
2. Nankivell BJ, Borrows RJ, Fung CL, et al. The natural history of chronic allograft nephropathy. N Engl J Med 2003; 349: 2326.
3. Nankivell BJ, Chapman JR. Chronic allograft nephropathy: Current concepts and future directions. Transplantation 2006; 81: 643.
4. Halloran PF, Aprile MA, Farewell V, et al. Early function as the principal correlate of graft survival. A multivariate analysis of 200 cadaveric renal transplants treated with a protocol incorporating antilymphocyte globulin and cyclosporine. Transplantation 1988; 46: 223.
5. Kahan BD, Mickey R, Flechner SM, et al. Multivariate analysis of risk factors impacting on immediate and eventual cadaver allograft survival in cyclosporine-treated recipients. Transplantation 1987; 43: 65.
6. Troppmann C, Gillingham KJ, Gruessner RW, et al. Delayed graft function in the absence of rejection has no long-term impact. A study of cadaver kidney recipients with good graft function at 1 year after transplantation. Transplantation 1996; 61: 1331.
7. Mizutani K, Terasaki P. Serum creatinine as a predictor of transplant survival and death. Clin Transpl 2004: 345.
8. Salvadori M, Rosati A, Bock A, et al. Estimated one-year glomerular filtration rate is the best predictor of long-term graft function following renal transplant. Transplantation 2006; 81: 202.
9. Lange H, Muller TF, Ebel H, et al. Immediate and long-term results of ATG induction therapy for delayed graft function compared to conventional therapy for immediate graft function. Transpl Int 1999; 12: 2.
10. Goggins WC, Pascual MA, Powelson JA, et al. A prospective, randomized, clinical trial of intraoperative versus postoperative Thymoglobulin in adult cadaveric renal transplant recipients. Transplantation 2003; 76: 798.
11. Beiras-Fernandez A, Chappell D, Hammer C, et al. Influence of polyclonal anti-thymocyte globulins upon ischemia-reperfusion injury in a non-human primate model. Transpl Immunol 2006; 15: 273.
12. 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.
13. Brennan DC, Flavin K, Lowell JA, et al. A randomized, double-blinded comparison of Thymoglobulin versus Atgam for induction immunosuppressive therapy in adult renal transplant recipients. Transplantation 1999; 67: 1011.
14. Brennan DC, Daller JA, Lake KD, et al. Rabbit antithymocyte globulin versus basiliximab in renal transplantation. N Engl J Med 2006; 355: 1967.
15. Genestier L, Fournel S, Flacher M, et al. Induction of Fas (Apo-1, CD95)-mediated apoptosis of activated lymphocytes by polyclonal antithymocyte globulins. Blood 1998; 91: 2360.
16. Kyllonen LE, Eklund BH, Pesonen EJ, et al. Single bolus antithymocyte globulin versus basiliximab induction in kidney transplantation with cyclosporine triple immunosuppression: Efficacy and safety. Transplantation 2007; 84: 75.
17. Starzl TE, Murase N, Abu-Elmagd K, et al. Tolerogenic immunosuppression for organ transplantation. Lancet 2003; 361: 1502.
18. Gallon L, Perico N, Dimitrov BD, et al. Long-term renal allograft function on a tacrolimus-based, pred-free maintenance immunosuppression comparing sirolimus vs. MMF. Am J Transplant 2006; 6: 1617.
19. 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.
20. Levey AS, Bosch JP, Lewis JB, et al. 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.
21. Coresh J, Astor BC, McQuillan G, et al. Calibration and random variation of the serum creatinine assay as critical elements of using equations to estimate glomerular filtration rate. Am J Kidney Dis 2002; 39: 920.
22. Myers GL, MillerWG,Coresh J, et al. Recommendations for improving serum creatinine measurement: a report from the Laboratory Working Group of the National Kidney Disease Education Program. Clin Chem 2006; 52: 5.
23. Racusen LC, Solez K, Colvin RB, et al. The Banff 97 working classification of renal allograft pathology. Kidney Int 1999; 55: 713.
24. Muller TF, Grebe SO, Neumann MC, et al. Persistent long-term changes in lymphocyte subsets induced by polyclonal antibodies. Transplantation 1997; 64: 1432.
25. Klaus G, Mostert K, Reckzeh B, et al. Phenotypic changes in lymphocyte subpopulations in pediatric renal-transplant patients after T-cell depletion. Transplantation 2003; 76: 1719.
26. Esposito L, Kamar N, Tkaczuk J, et al. Long-term evolution of lymphocytes subsets after induction therapy based on continuous versus discontinuous administration of anti-thymocyte globulins in renaltransplant patients. Transplant Proc 2005; 37: 785.
27. Louis S, Audrain M, Cantarovich D, et al. Long-term cell monitoring of kidney recipients after an antilymphocyte globulin induction with and without steroids. Transplantation 2007; 83: 712.
28. Michallet MC, Preville X, Flacher M, et al. Functional antibodies to leukocyte adhesion molecules in antithymocyte globulins. Transplantation 2003; 75: 657.
29. Preville X, Flacher M, LeMauff B, et al. Mechanisms involved in antithymocyte globulin immunosuppressive activity in a nonhuman primate model. Transplantation 2001; 71: 460.
30. Jaber JJ, Feustel PJ, Elbahloul O, et al. Early steroid withdrawal therapy in renal transplant recipients: A steroid-free sirolimus and Cell Ceptbased calcineurin inhibitor-minimization protocol. Clin Transplant 2007; 21: 101.
31. Alexander JW, Goodman HR, Cardi M, et al. Simultaneous corticosteroid avoidance and calcineurin inhibitor minimization in renal transplantation. Transpl Int 2006; 19: 295.
32. Shapiro R, Jordan ML, Basu A, et al. Kidney transplantation under a tolerogenic regimen of recipient pretreatment and low-dose postoperative immunosuppression with subsequent weaning. Ann Surg 2003; 238: 520.
33. Gera M, Slezak JM, Rule AD, et al. Assessment of changes in kidney allograft function using creatinine-based estimates of glomerular filtration rate. Am J Transplant 2007; 7: 880.
34. Ibrahim HN, Rogers T, Tello A, et al. The performance of three serum creatinine-based formulas in estimating GFR in former kidney donors. Am J Transplant 2006; 6: 1479.
35. Chappell D, Beiras-Fernandez A, Hammer C, et al. In vivo visualization of the effect of polyclonal antithymocyte globulins on the microcirculation after ischemia/reperfusion in a primate model. Transplantation 2006; 81: 552.
36. Najafian N, Khoury SJ, Sayegh MH. T cell costimulatory blockade as a novel immune intervention in autoimmune diseases. Clin Dermatol 2001; 19: 586.
37. Lopez M, Clarkson MR, Albin M, et al.Anovel mechanism of action for anti-thymocyte globulin: Induction of CD4-CD25-Foxp3- regulatory T cells. J Am Soc Nephrol 2006; 17: 2844.
38. Zand MS, Vo T, Huggins J, et al. Polyclonal rabbit antithymocyte globulin triggers B-cell and plasma cell apoptosis by multiple pathways. Transplantation 2005; 79: 1507.
39. Solez K, Colvin RB, Racusen LC, et al. Banff '05 Meeting Report: Differential diagnosis of chronic allograft injury and elimination of chronic allograft nephropathy ('CAN'). Am J Transplant 2007; 7: 518.
40. Poggio ED, Batty DS, Flechner SM. Evaluation of renal function in transplantation. Transplantation 2007; 84: 131.