Shapiro, R and Jordan, M and Scantlebury, V and Vivas, C and Fung, J and McCauley, J and Tzakis, A and Randhawa, P and Demetris, AJ and Irish, W and Mitchell, S and Jensen, C and Jain, A and Hakala, TR and Simmons, RL and Starzl, TE
(1994)
A prospective, randomized trial of FK-506 in renal transplantation - A comparison between double- and triple-drug therapy.
Clinical Transplantation, 8 (6).
508 - 515.
ISSN 0902-0063
Abstract
Previous clinical evaluation of FK506 in renal transplantation has demonstrated equivalent patient and graft survival when compared with cyclosporine-based regimens. However, lower steroid and anti-hypertensive medication requirements and lower serum cholesterol levels have been seen in patients receiving FK506. In August, 1991, a prospective, randomized trial was begun, comparing FK506/prednisone with FK506/azathioprine/prednisone. Two-hundred-and-four adults were entered into this trial between August 1, 1991, and October 11, 1992. The mean recipient age was 43.8 ± 13.7 years, with a range of 17.6-78.0 years. Sixty-one (30%) recipients received a 2nd, 3rd or 4th transplant, while 35 (17%) had a PRA greater than 40% at the time of transplant. Thirty-three (16%) of the transplants were in recipients over 60 years of age, Thirteen percent of the kidneys were from living donors; 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 hours, and the mean donor age was 34 ± 2.10 years, with a range from 4 months to 75 years. With a mean follow-up of 9 ± 4 months, the 1-year actuarial patient survival is 93%; for the two-drug group it is 95%, and for the three-drug group it is 91% (p = NS). One-year actuarial graft survival is 86%, in the two-drug group it is 90%, while in the three-drug group it is 82% (p = NS). The mean serum creatinine and BUN are 1.85 ± 0.76 mg/dl and 30 ± 14 mg/dl; the values are not significantly different between the two- and three-drug groups. Rejection was seen in 45% of patients, 51% in the two-drug and 39% in the three-drug group (p = 0.09). In cadaveric recipients, more rejection was seen in the two-drug group (58%) than in the three-drug group (39%; p < 0.02: 24 (12%) of patients required OKT3 or ATGAM(®) for rejection: 24 (12%) had cytomegalovirus; an equal incidence was seen in both groups. New onset diabetes was seen in 14% of patients; there was a higher incidence in the two-drug (20%) than in the three-drug (8%) group (p < 0.03). The incidence of PTLD was 1% (2 patients). Crossover between the two limbs was seen commonly: 26/25%) of the patients in the two-drug group required the addition of azathioprine, while 46 (45%) of the patients in the three-drug group required discontinuation of azathioprine (usually because of a falling white blood cell count or hepatic dysfunction). Sixty-five (32%) patients are off steroids, while 88 (43%) patients are not taking any antihypertensive medications. The mean serum cholesterol is 193 ± 53 mg/dl. These data confirm earlier reports about the efficacy of FK506 in renal transplantation. The benefit of azathioprine is unclear, with no improvement in patient and graft survival and a higher crossover rate, but with less rejection in certain subgroups and less diabetes.
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| Item Type: |
Article
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| Status: |
Published |
| Creators/Authors: |
| Creators | Email | Pitt Username | ORCID  |
|---|
| Shapiro, R | | | | | Jordan, M | | | | | Scantlebury, V | | | | | Vivas, C | | | | | Fung, J | | | | | McCauley, J | | | | | Tzakis, A | | | | | Randhawa, P | | | | | Demetris, AJ | | | | | Irish, W | | | | | Mitchell, S | | | | | Jensen, C | | | | | Jain, A | | | | | Hakala, TR | | | | | Simmons, RL | | | | | Starzl, TE | tes11@pitt.edu | TES11 | |
|
| Centers: |
Other Centers, Institutes, Offices, or Units > Thomas E. Starzl Transplantation Institute |
| Date: |
14 December 1994 |
| Date Type: |
Publication |
| Journal or Publication Title: |
Clinical Transplantation |
| Volume: |
8 |
| Number: |
6 |
| Page Range: |
508 - 515 |
| Institution: |
University of Pittsburgh |
| Refereed: |
Yes |
| ISSN: |
0902-0063 |
| Other ID: |
uls-drl:31735062126861, Starzl CV No. 1787 |
| Date Deposited: |
08 Apr 2010 17:30 |
| Last Modified: |
04 Feb 2019 15:58 |
| URI: |
http://d-scholarship.pitt.edu/id/eprint/5173 |
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