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A prospective randomized trial of FK506-based immunosuppression after renal transplantation

Shapiro, R and Jordan, ML and Scantlebury, VP and Vivas, C and Fung, JJ and McCauley, J and Randhawa, P and Demetris, AJ and Irish, W and Mitchell, S and Hakala, TR and Simmons, RL and Starzl, TE (1995) A prospective randomized trial of FK506-based immunosuppression after renal transplantation. Transplantation, 59 (4). 485 - 490. ISSN 0041-1337

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Abstract

A group of 204 adult patients was entered into a prospective, randomized trial comparing FK506/pred-nisone with FK506/azathioprine/prednisone after renal transplantation between August 1, 1991 and October 11,1992. The purpose of the study was to see if the addition of azathioprine would reduce the incidence of rejection and improve graft survival. The recipient population was unselected, with 61 (30%) patients undergoing retransplantation, 37 (18%) having a panel-reactive antibody grea ter than 40%, and 33 (16%) over 60 years of age. The mean recipient age was 43.8±13.7 years (range 17.6-78). The mean donor age was 34.0±20.1 years (range 0.3-75); 13% of the cadaveric kidneys were from pediatric donors less than 3 years of age and were transplanted en bloc. The mean cold ischemia time was 31.4±8.4 hr. Living donors were the source of 13% of the kidneys. The mean follow-up was 22±4 months (range 12-29). Overall one-year actual patient survival was 94%. Overall one-year actual graft survival was 87%. Patients starting on double therapy had a one-year actual patient survival of 96% and a one-year actual graft survival of 92%. Patients starting on triple therapy had a one-year actual patient survival of 91% (P=ns compared with double therapy), and a one-year actual graft survival of 82% (P < 0.02, compared with double therapy). Overall results with first cadaver transplants included a one-year actual patient survival of 94% and one-year actual graft survival of 88%, with no differences between double and triple therapy. The overall incidence of rejection was 48%, with 54% in the double therapy group and 41% in the triple therapy group (P < .07). The incidence of steroid-resistant rejection requiring antilymphocyte therapy (OKT3 or ATGAM) was 13%, and was not different between the double and triple therapy groups. The mean serum creatinine was 1.8±0.8 mg/dl. The mean BUN was 33±21 mg/dl, with no significant difference between the therapy groups. The mean serum cholesterol was 192 ±49 mg/dl. A total of 56% of the patients are off prednisone, and 35% of the patients are not taking any antihypertensive medications. Other complications included cytomegalovirus—14%; new-onset diabetes—16% (half of which was reversible); and posttransplant lymphoproliferative disorder—1%. There was a high incidence of crossover between the two groups, 27% of the patients in the double therapy group requiring the addition of azathioprine, and 45% of the patients in the triple therapy group requiring its discontinuation (usually tempoгагу). These results show that FK506 is an excellent immunosuppressive agent after renal transplantation and that azathioprine is not routinely effective as a third agent. A high quality of life resulted from the ability to use no (56%) or low-dose maintenance steroids. © 1995 by Williams and Wilkins.


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Details

Item Type: Article
Status: Published
Creators/Authors:
CreatorsEmailPitt UsernameORCID
Shapiro, R
Jordan, ML
Scantlebury, VP
Vivas, C
Fung, JJ
McCauley, J
Randhawa, P
Demetris, AJ
Irish, W
Mitchell, S
Hakala, TR
Simmons, RL
Starzl, TEtes11@pitt.eduTES11
Centers: Other Centers, Institutes, or Units > Thomas E. Starzl Transplantation Institute
Date: 27 February 1995
Date Type: Publication
Journal or Publication Title: Transplantation
Volume: 59
Number: 4
Page Range: 485 - 490
Institution: University of Pittsburgh
Refereed: Yes
ISSN: 0041-1337
Other ID: uls-drl:31735062124759, Starzl CV No. 1679
Date Deposited: 08 Apr 2010 17:28
Last Modified: 13 Oct 2017 21:57
URI: http://d-scholarship.pitt.edu/id/eprint/5065

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