One-year follow-up of an open-label trial of FK506 for primary kidney transplantation: A report of the U.S. Multicenter FK506 Kidney Transplant group

Transplantation

Volumn 61, Issue 11, 1996, Pages 1576-1581

  Vincenti, Flavio ^a,f   Laskow, David A ^b   Neylan, John F ^c   Mendez, Robert ^d   Matas, Arthur J ^e  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b UAB Department of Surgery   (United States)

^c EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d National Institute of Transplantation Los Angeles   (United States)

^e UNIVERSITY OF MINNESOTA MEDICAL SCHOOL   (United States)

^f UCSF Medical Center at Parnassus   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AZATHIOPRINE; CREATININE; CYCLOSPORIN; INSULIN; LYMPHOCYTE ANTIBODY; PREDNISOLONE; PREDNISONE; STEROID; TACROLIMUS;

ADULT; ARTICLE; CADAVER KIDNEY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG SAFETY; ENZYME LINKED IMMUNOSORBENT ASSAY; FEMALE; FOLLOW UP; GASTROINTESTINAL SYMPTOM; GRAFT REJECTION; GRAFT SURVIVAL; HUMAN; HYPERGLYCEMIA; IMMUNOSUPPRESSIVE TREATMENT; KIDNEY BIOPSY; KIDNEY TRANSPLANTATION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NEPHROTOXICITY; NEUROTOXICITY; ORAL DRUG ADMINISTRATION; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL;

ADULT; FEMALE; FOLLOW-UP STUDIES; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; MALE; MIDDLE AGED; TACROLIMUS;

EID: 0029898275     PISSN: 00411337     EISSN: None     Source Type: Journal    
DOI: 10.1097/00007890-199606150-00005     Document Type: Article

References (40)

1. UNOS. UNOS releases 1993 transplant statistics. UNOS Update 1994; 1: 3.
2. Calne RY. Cyclosporin in cadaveric renal transplantation: 5-year follow-up of a multicentre trial. Lancet 1987; 2: 506.
3. Milhatsch MJ, Thiel G, Ryffel B. Histopathology of cyclosporine nephrotoxicity. Transplant Proc 1988; 20 (suppl 3): 759.
4. Myers BD. Cyclosporine nephrotoxicity. Kidney Int 1986; 30: 964.
5. Ponticelli C, Tarantino A, Montagnino G, et al. A randomized trial comparing triple-drug and double-drug therapy in renal transplantation. Transplantation 1988; 45: 913.
6. Wrenshall LE, Matas AJ, Canafax DM, et al. An increased incidence of late acute rejection episodes in cadaver renal allograft recipients given azathioprine, cyclosporine, and prednisone. Transplantation 1990; 50: 233.
7. Kino T, Hatanaka H, Hashimoto M, et al. FK-506, a novel immunosuppressant isolated from a Streptomyces. I. Fermentation, isolation, and physico-chemical and biological characteristics. J Antibiot 1987; 40: 1249.
8. Kino T, Hatanaka H, Miyata S, et al. FK-506, A novel immunosuppressant isolated from a Streptomyces. II. Immunosuppressive effect of FK-506 in vitro. J Antibiot 1987; 40: 1256.
9. Goto T, Kino T, Hatanaka M, et al. FK506: historical perspectives. Transplant Proc 1991; 23: 2713.
10. Sigal NH, Lin CS, Siekierka JJ. Inhibition of human T-cell activation by FK506, rapamycin, and cyclosporine A. Transplant Proc 1991; 23: 1.
11. Jiang H, Suguo H, Takahara S, et al. Combined immunosuppressive effect of FK506 and other immunosuppressive agents on PHA- and CD3-stimulated human lymphocyte proliferation in vitro. Transplant Proc 1991; 23: 2933.
12. Tsuchimoto S, Kusumoto K, Nakajiwa Y, et al. Orthotopic liver transplantation in rats receiving FK506. Transplant Proc 1989; 21: 1064.
13. Jiang H, Takahara S, Takano Y, et al. Effect of FK506 on heart allograft survival in highly sensitized recipient rats in comparison with cyclosporine. Transplant Proc 1991; 23: 540.
14. Ochiai T, Nagata M, Nakajima K, et al. Studies of the effects of FK506 on renal allografting in the beagle dog. Transplantation 1987; 44: 729.
15. Ochiai T, Nagata M, Nakajima K, Sakamoto K, Asano T, Isono K. Prolongation of canine renal allograft survival by treatment with FK-506. Transplant Proc 1987; 19: 53.
16. Ochiai T, Nakajima K, Nagata M, et al. Effect of a new immunosuppressant agent, FK 506, on heterotopic cardiac allotransplantation in the rat. Transplant Proc 1987; 19: 1284.
17. Isai H, Painter DM, Sheil AGR. FK506 and orthotopic liver transplantation in the rat. Transplant Proc 1990; 22: 2125.
18. Armitage JM, Flicker FJ, Del Nido P, Cipriani L, Starzl TE. The clinical trial of FK506 as primary and rescue immunosuppression in pediatric cardiac transplantation. Transplant Proc 1991; 23: 3058.
19. Armitage JM, Kormos RL, Fung J, Starzl TE. The clinical trial of FK506 as primary and rescue immunosuppression in adult cardiac transplantation. Transplant Proc 1991; 23: 3054.
20. U.S. Multicenter FK506 Liver Study Group. A comparison of tacrolimus (FK506) and cyclosporine for immunosuppression in liver transplantation. N Engl J Med 1994; 331: 1110.
21. Jensen CWB, Jordan ML, Schneck FX, et al. Pediatric renal transplantation under FK506 immunosuppression. Transplant Proc 1991; 23: 3075.
22. Jordan JL, Shapiro R, Vivas CA, et al. FK506 salvage of renal allografts with ongoing rejection failing cyclosporine immunosuppression. Transplant Proc 1993; 25: 638.
23. Shapiro R, Jordan M, Scantlebury V, et al. FK506 in clinical kidney transplantation. Transplant Proc 1991; 23: 3065.
24. Japanese FK506 Study Group. Clinicopathological evaluation of kidney transplants in patients given a fixed dose of FK506. Transplant Proc 1991; 23: 3111.
25. Japanese FK506 Study Group. Japanese study of FK506 on kidney transplantation: results of late phase II study. Transplant Proc 1993; 25: 649.
26. Japanese FK506 Study Group. Morphological characteristics of renal allografts showing renal dysfunction under FK506 therapy, is graft biopsy available to reveal the morphological findings corresponding with FK506 nephrotoxicity. Transplant Proc 1993; 25: 624.
27. Shapiro R, Jordan ML, Scantlebury VP, et al. Randomized trial of FK506/prednisone vs FK506/azathioprine/prednisone after renal transplantation: preliminary report. Transplant Proc 1993; 25: 669.
28. Laskow DA, for the U.S. Multicenter FK506 Kidney Transplant Group. An open-label, concentration-ranging trial of FK506 in primary kidney transplantation. Transplantation (in press).
29. Jusko WJ, D'Ambrosio R. Monitoring FK 506 concentrations in plasma and whole blood. Transplant Proc 1991; 23: 2732.
30. Kobayashi M, Tamura K, Katayama N, et al. FK506 assay past and present characteristics of FK506 ELISA. Transplant Proc 1991; 23: 2725.
31. Grenier FC, Luczkiw J, Bergmann M, et al. A whole blood FK506 assay for the IMx Analyzer. Transplant Proc 1991; 23: 2748.
32. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958; 53: 1457.
33. European FK506 Multicentre Liver Study Group. Randomised trial comparing tacrolimus (FK506) and cyclosporin in prevention of liver allograft rejection. Lancet 1994; 344: 423.
34. Jordan ML, Shapiro R, Vivas CA, et al. FK506 "rescue" for resistant rejection of renal allografts under primary cyclosporine immunosuppression. Transplantation 1994; 57: 860.
35. Shapiro R, Jordan ML, Scantlebury VP, et al. A prospective randomized trial of FK506-based immunosuppression after renal transplantation. Transplantation 1995; 59: 485.
36. Canadian Multicentre Transplant Study Group. A randomized clinical trial of cyclosporine in cadaveric renal transplantation. N Engl J Med 1986; 314: 1219.
37. Merion RM, White DJG, Thiru S, et al. Cyclosporine: five years' experience in cadaveric renal transplantation. N Engl J Med 1984; 310: 148.
38. Fung JJ, Alessiani M, Abu-Elmagd K, et al. Adverse effects associated with the use of FK 506. Transplant Proc 1991; 23: 3105.
39. Tauxe WN, Mochizuki T, McCauley J, et al. A comparison of the renal effects (ERPF, GFR, and FF) of FK 506 and cyclosporine in patients with liver transplantation. Transplant Proc 1991; 23: 3146.
40. McCauley J, Fung JJ, Todo S, et al. Changes in renal function after liver transplantation under FK 506. Transplant Proc 1991; 23: 3143.