Sirolimus reduces the incidence of acute rejection episodes despite lower cyclosporine doses in caucasian recipients of mismatched primary renal allografts: A phase II trial

Transplantation

Volumn 68, Issue 10, 1999, Pages 1526-1532

  Kahan, Barry D ^a   Julian, Bruce A ^b   Pescovitz, Mark D ^b   Vanrenterghem, Yves ^b   Neylan, John ^b  

^a UNIVERSITY OF TEXAS MEDICAL SCHOOL   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

CYCLOSPORIN A; RAPAMYCIN; STEROID;

ADULT; ARTICLE; CAUCASIAN; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIABETES MELLITUS; FEMALE; HUMAN; HYPERTENSION; IMMUNE RESPONSE; IMMUNOSUPPRESSIVE TREATMENT; KIDNEY ALLOGRAFT; KIDNEY GRAFT REJECTION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PRIORITY JOURNAL; PROPHYLAXIS; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT;

EID: 0033610638     PISSN: 00411337     EISSN: None     Source Type: Journal    
DOI: 10.1097/00007890-199911270-00016     Document Type: Article

References (31)

1. Calne RY, Collier DS, Lim S, et al. Rapamycin for immunosuppression in organ allografting. Lancet 1989; 2: 227.
2. Morris RE, Meiser BM. Identification of a new pharmacologic action for an old compound. Med Sci Res 1989; 17: 877.
3. Kahan BD, Chang JY, Sehgal SN. Preclinical evaluation of a new potent immunosuppressive agent, rapamycin. Transplantation 1991; 52: 185.
4. Sehgal SN. Rapamune (sirolimus, rapamycin): an overview and mechanism of action. Ther Drug Monit 1995; 17: 660.
5. Groth CG, Backman L, Morales JM, et al. Sirolimus (rapamycin)-based therapy in human renal transplantation: similar efficacy and different toxicity compared with cyclosporine. Sirolimus European Renal Transplant Study Group. Transplantation 1999; 67: 1036.
6. Kahan BD, Gibbons S, Tejpal N. Stepkowski SM, Chou TC. Synergistic interactions of cyclosporine and rapamycin to inhibit immune performances of normal human peripheral blood lymphocytes in vitro. Transplantation 1991; 51: 185.
7. Stepkowski SM, Tian L, Napoli KL, et al. Synergistic mechanisms by which sirolimus and cyclosporine inhibit rat heart and kidney allograft rejection. CHn Exp Immunol 1997; 108: 63.
8. Yakimets WJ, Lackey JR, Yatscoff RW, et al. Prolongation of canine pancreatic islet allograft survival with combined rapamycin and cyclosporine therapy at low doses: Rapamycin efficacy is blood level related. Transplantation 1993; 56: 1293.
9. Murgia MG, Jordan S, Kahan BD. The side effect profile of sirolimus: a phase I study in quiescent cyclosporine-prednisone-treated renal transplant patients. Kidney Int 1996; 49: 209.
10. Kahan BD, Podbielski J, Napoli KL, Katz SM, Meier-Kriesche H-U, Van Buren CT. Immunosuppressive effects and safety of a sirolimus/cyclosporine combination regimen for renal transplantation. Transplantation 1998; 66: 1040.
11. Dumont FJ, Staruch MJ, Koprak SL, et al. The immunosuppressive and toxic effects of FK-506 are mechanistically related: pharmacology of a novel antagonist of FK-506 and rapamycin. J Exp Med 1992; 176: 751.
12. DiJoseph JF, Sharma RN, Chang JY. The effect of rapamycin on kidney function in the Sprague-Dawley rat. Transplantation 1992; 53: 507.
13. Golbaekdal K, Nielsen CB, Djurhuus JC, Pedersen EB. Effects of rapamycin on renal hemodynamics, water and sodium excreation, and plasma levels of angiotensin II, aldosterone, atrial natriuretic peptide and vasopressin in pigs. Transplantation 1994; 58: 1153.
14. Andoh TF, Burdmann EA, Bennett WM. Nephrotoxicity of immunosuppressive drugs: experimental and clinical observations. Semin Nephrol 1997; 17: 34.
15. Bennett WM. Insights into chronic cyclosporine nephrotoxicity. Int J Clin Pharmacol Ther 1996; 34: 515.
16. 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.
17. Nankivell BJ, Gruenewald SM, Allen RD, Chapman JR. Predicting glomerular filtration rate after kidney transplantation. Transplantation 1995; 59: 1683.
18. Sollinger HW. Mycophenolate mofetil for the prevention of acute rejection in primary cadaveric renal allograft recipients. U.S. Renal Transplant Mycophenolate Mofetil Study Group. Transplantation 1995; 60: 225.
19. Tricontinental Mycophenolate Mofetil Renal Transplantation Study Group. A blinded, randomized clinical trial of mycophenolate mofetil for the prevention of acute rejection in cadavericrenal transplantation. Transplantation 1996; 61: 1029.
20. Lindholm A, Kahan BD. Influence of cyclosporine pharmacokinetics, trough concentrations, and AUC monitoring on outcome after kidney transplantation. Clin Pharmacol Ther 1993; 54: 205.
21. Lindholm A, Ohlman S, Albrechtsen D, et al. The impact of acute rejection episodes on long-term graft function and outcome in 1347 primary renal transplants treated by 3 cyclosporine regimens. Transplantation 1993; 56: 307.
22. Kahan BD, Kramer WG, Wideman C, Flechner SM, Lorber MI, Van Buren CT. Demographic factors affecting the pharmacokinetics of cyclosporine estimated by radioimmunoassay. Transplantation 1986; 41: 459.
23. Zimmerman J, Kahan BD. Pharmacokinetics of sirolimus in stable renal transplant patients after multiple oral dose administration. J Clin Pharmacol 1997; 37: 405.
24. Dantal J, Hourmant M, Cantarovich D, et al. Effect of long-term immunosuppression in kidney-graft recipients on cancer incidence: randomised comparison of two cyclosporin regimens. Lancet 1998; 1: 623.
25. Ponticelli C, Minetti L, Di Palo FQ, et al. The Milan clinical trial with cyclosporine in cadaveric renal transplantation. A three-year follow-up. Transplantation 1988; 45: 908.
26. The Canadian Multicentre Transplant Study Group. A randomized clinical trial of cyclosporine in cadaveric renal transplantation. Analysis at three years. N Engl J Med 1986; 314: 1219.
27. Weidle PJ, Masses PH. Systemic hypertension associated with cyclosporine: a review. Drug Intell Clin Pharm 1988; 22: 443.
28. Vathsala A, Weinberg RB, Schoenberg L, et al. Lipid abnormalities in cyclosporine-prednisone-treated renal transplant recipients. Transplantation 1989; 48: 37.
29. Kasiske BL, Tortorice KL, Heim-Duthoy KL, Awni WM, Rao KV. The adverse impact of cyclosporine on serum lipids in renal transplant recipients. Am J Kidney Dis 1991; 17: 700.
30. MacDonald AS for the Rapamune Global Study Group. A randomized, placebo-controlled trial of Rapamune in primary renal allograft recipients. Abstracts of the Transplantation Society XXVII World Congress, Montreal 1998 (Abstract 426).
31. Kahan BD for the Rapamune U.S. Study Group. A phase III comparative efficacy trial of Rapamune in renal allograft recipients. XVII World Congress, Montreal, Canada 1998 (Abstract 198).