A randomized, double-blinded comparison of thymoglobulin versus Atgam for induction immunosuppressive therapy in adult renal transplant recipients

Transplantation

Volumn 67, Issue 7, 1999, Pages 1011-1018

  Brennan, Daniel C ^a,d   Flavin, Karen ^a   Lowell, Jeffrey A ^a   Howard, Todd K ^a   Shenoy, Surendra ^a   Burgess, Sandra ^b   Dolan, Sara ^b   Kano, Jennifer M ^c   Mahon, Mitchell ^b   Schnitzler, Mark A ^a   Woodward, Robert ^a   Irish, William ^c   Singer, Gary G ^a  

^a WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b BARNES JEWISH HOSPITAL   (United States)

^c GENZYME CORPORATION   (United States)

^d 6107 Queeny Tower ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACICLOVIR; AZATHIOPRINE; COTRIMOXAZOLE; CYCLOSPORIN; CYCLOSPORIN A; GANCICLOVIR; METHYLPREDNISOLONE; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; TACROLIMUS; THYMOCYTE ANTIBODY;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYTOMEGALOVIRUS INFECTION; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FORMULATION; DRUG SAFETY; FEMALE; GRAFT REJECTION; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; INTRAVENOUS DRUG ADMINISTRATION; KIDNEY TRANSPLANTATION; LEUKOPENIA; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; ORAL DRUG ADMINISTRATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECIPIENT; SURVIVAL;

ADOLESCENT; ADULT; AGED; ANTIBODIES; ANTILYMPHOCYTE SERUM; CHILD; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; GRAFT REJECTION; HUMANS; IMMUNOSUPPRESSIVE AGENTS; INCIDENCE; INFANT, NEWBORN; KIDNEY TRANSPLANTATION; LEUKOCYTE COUNT; MIDDLE AGED; SURVIVAL ANALYSIS;

EID: 0033561405     PISSN: 00411337     EISSN: None     Source Type: Journal    
DOI: 10.1097/00007890-199904150-00013     Document Type: Article

References (43)

1. Cecka JM, Cho YW, Terasaki PI. Analyses of the UNOS scientific renal transplant registry at three years: early events affecting transplant success. Transplantation 1992; 53: 59.
2. Norman DJ, Kahana L, Stuart FP Jr, et al. A randomized clinical trial of induction therapy with OKT3 in kidney transplant. Transplantation 1993; 55: 44.
3. Shield CF, Jacobs RJ, Wyant S, Das A. A cost-effectiveness analysis of OKT3 induction therapy in cadaveric kidney transplant. Am J Kidney Dis 1996; 27: 855.
4. Gaston RS, Hudson SL, Deierhoi MH, et al. Improved survival of primary cadaveric renal allografts in blacks with quadruple immunosuppression. Transplantation 1992; 53: 103.
5. Ettenger RB, Rosenthal JT, Marik JL, et al. Improved cadaveric renal transplant outcome in children. Pediatr Nephrol 1991; 5: 137.
6. Schroeder TJ, First MR, Mansour ME, Alexander JW, Penn I. Prophylactic use of OKT3 in immunologic high-risk cadaver renal transplant recipients. Am J Kidney Dis 1989; 14 (suppl 2): 14.
7. Brennan DC, Schnitzler MA, Baty JD, et al. A pharmaco-economic comparison of antithymocyte globulin and muromonab CD3 induction therapy in renal transplant recipients. PharmacoEconomics 1997; 11: 237.
8. Cardella CJ, Cattran D, Fenton SA, Albert S, Robinette M, Cole E. Induction therapy with rabbit antithymocyte sera reduces rejection episodes in immunologically low-risk living donor renal transplant recipients. Transplant Proc 1997; 29: 29S.
9. Opelz G. Efficacy of rejection prophylaxis with OKT3 in renal transplant. Transplantation 1995; 60: 1220.
10. Opelz G. Efficacy of rejection prophylaxis with OKT3 [Reply]. Transplantation 1996; 62: 701.
11. Shield CF, Edwards EB, Davies DB, Daily OP. Antilymphocyte induction therapy in cadaver renal transplant: a retrospective, multicenter United Network for Organ Sharing Study. Transplantation 1997; 63: 1257.
12. Szczech LA, Berlin JA, Aradhye S, Grossman RA, Feldman HI. Effect of anti-lymphocyte induction therapy on renal allograft survival: a meta-analysis. J Am Soc Nephrol 1997; 8: 1771.
13. Hibberd PL, Tolkoff-Rubin NE, Cosimi AB, et al. Symptomatic cytomegalovirus disease in the cytomegalovirus antibody sero-positive renal transplant recipient treated with OKT3. Transplantation 1992; 53: 68.
14. Swinnen LJ, Costanzo-Nordin MR, Fisher SG, et al. Increased incidence of lymphoproliferative disorder after immunosuppression with the monoclonal antibody OKT3 in cardiac transplant recipients. N Engl J Med 1990; 323: 1723.
15. Bonnefoy-Berard N, Vincent C, Revillard JP. Antibodies against functional leukocyte surface molecules in polyclonal antilymphocyte and antithymocyte globulins. Transplantation 1991; 51: 669.
16. Bourdage JS, Hamlin DM. Comparative polyclonal antilymphocyte globulin and antilymphocyte/antilymphoblast globulin anti-CD antigen analysis by flow cytometry. Transplantation 1995; 59: 1194.
17. Benvenisty AI, Tannenbaum GA, Cohen DJ, Tannenbaum GA, Appel G, Hardy MA. Use of antithymocyte globulin and cyclosporine to treat steroid-resistant rejection episodes in renal transplant recipients. Transplant Proc 1987; 19: 1889.
18. O'Donoghue DJ, Johnson RW, Mallick NP, et al. Rabbit antithymocyte globulin treatment of steroid resistant rejection in renal allograft recipients immunosuppressed with cyclosporine A. Transplant Proc 1989; 21: 1736.
19. Filo RS, Smith EJ, Leapman SB. Reversal of acute cadaveric renal allograft rejection with adjunctive ATG therapy. Transplant Proc 1981; 13: 482.
20. Gaber AO, First MR, Tesi RJ, et al. Results of the double-blinded, randomized, multicenter, phase III clinical trial of Thymoglobulin versus Atgam in the treatment of acute graft rejection episodes following renal transplant. Transplantation 1998; 66: 29.
21. Brennan DC, Garlock KA, Singer GG, et al. Prophylactic oral ganciclovir compared with deferred therapy for control of cytomegalovirus in renal transplant recipients. Transplantation 1997; 64: 1843.
22. Brennan DC, Garlock KA, Lippmann BA, et al. Control of cytomegalovirus-associated morbidity in renal transplant patients using intensive monitoring and either preemptive or deferred therapy. J Am Soc Nephrol 1997; 8: 118.
23. Solez K, Axelsen RA, Benediktsson H, et al. International standardization of criteria for the histologic diagnosis of renal allograft rejection: the Banff working classification of kidney transplant pathology. Kidney Int 1993; 44: 411.
24. Regan J, Campbell K, van Smith L, et al. Characterization of anti-Thymoglobulin, anti-Atgam and anti-OKT3 IgG antibodies in human serum with an 11-min ELISA. Transpl Immunol 1997; 5: 49.
25. Mantel N. Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemother Rep 1966; 50: 163.
26. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958; 53: 457.
27. Cox DR. Regression models and life tables. J R Stat Soc Series B 1972; 34: 187.
28. Hornef MW, Bein G, Fricke L, et al. Coincidence of Epstein-Barr virus reactivation, cytomegalovirus infection, and rejection episodes in renal transplant recipients. Transplantation 1995; 60: 474.
29. Bonnefoy-Berard N, Genestier L, Flacher M, et al. Apoptosis induced by polyclonal antilymphocyte globulins in human B-cell lines. Blood 1994; 83: 1051.
30. Malinow L, Walker J, Klassen D, et al. Antilymphocyte induction immunosuppression in the post-Minnesota anti-lymphocyte globulin era: incidence of renal dysfunction and delayed graft function. A single center experience. Clin Transplant 1996; 10: 237.
31. Takada M, Nadeau KC, Shaw GD, Marquette KA, Tilney NL. The cytokine-adhesion molecule cascade in ischemia/reperfusion injury of the rat kidney: inhibition by a soluble P-selectin ligand. Clin Invest 1997; 99: 2682.
32. Shoskes DA, Halloran PF. Delayed graft function in renal transplant: etiology, management and long-term significance. J Urol 1996; 6: 1831.
33. Nagano H, Tilney NL. Chronic allograft failure: the clinical problem. Am J Med Sci 1997; 313: 305.
34. Bonnefoy-Berard N, Revillard JP. Mechanisms of immunosuppression induced by antithymocyte globulins and OKT3. J Heart Lung Transplant 1996; 15: 435.
35. Bock HA, Gallati H, Zurcher RM, et al. A randomized prospective trial of prophylactic immunosuppression with ATG-Fresenius versus OKT3 after renal transplant. Transplantation 1995; 59: 830.
36. Soulillou JP, Cantarovich D, Le Mauff B, et al. Randomized controlled trial of a monoclonal antibody against the interleukin-2 receptor (33B3.1) as compared with rabbit antithymocyte globulin for prophylaxis against rejection of renal allografts. N Engl J Med 1990; 322: 1175.
37. Hourmant M, Le Mauff B, Cantarovich D, et al. Prevention of acute rejection episodes with an anti-interleukin-2 receptor monoclonal antibody. II. Results after a second kidney transplant. Transplantation 1994; 57: 204.
38. Cantarovich D, Le Mauff B, Hourmant M, et al. Prevention of acute rejection episodes with an anti-interleukin-2 receptor monoclonal antibody. I. Results after combined pancreas and kidney transplant. Transplantation 1994; 57: 198.
39. Kovarik J, Wolf P, Cisterne JM, et al. Disposition of basiliximab, an interleukin-2 receptor monoclonal antibody, in recipients of mismatched cadaver renal allografts. Transplantation 1997; 64: 1701.
40. Vincenti F, Lantz M, Birnbaum J, et al. A phase I trial of humanized anti-interleukin-2 receptor antibody in renal transplant. Transplantation 1997; 63: 33.
41. Vincenti F, Kirkman R, Light S, et al. Interleukin-2-receptor blockade with daclizumab to prevent acute rejection in renal transplant: Daclizumab Triple Therapy Study Group. N Engl J Med 1998; 338: 161.
42. Brown PS Jr, Parenteau GL, Dirbas FM, et al. Anti-Tac-H, a humanized antibody to the interleukin-2 receptor, prolongs primate cardiac allograft survival. Proc Natl Acad Sci USA 1991; 88: 2667.
43. Muller TF, Grebe SO, Neumann MC, et al. Persistent long term changes in lymphocyte subsets induced by polyclonal antibodies. Transplantation 1997; 64: 1432.