Shapiro, R and Jordan, ML and Scantlebury, VP and Vivas, C and Marsh, JW and McCauley, J and Johnston, J and Randhawa, P and Irish, W and Gritsch, HA and Naraghi, R and Hakala, TR and Fung, JJ and Starzl, TE
(1999)
A prospective, randomized trial of tacrolimus/prednisone versus tacrolimus/prednisone/mycophenolate mofetil in renal transplant recipients.
Transplantation, 67 (3).
411 - 415.
ISSN 0041-1337
Abstract
Background. Between September 20, 1995 and September 20, 1997, 208 adult patients undergoing renal transplantation were randomized to receive tacrolimus/prednisone (n=106) or tacrolimus/prednisone/mycophenolate mofetil (n=102), with the goal of reducing the incidence of rejection. Methods. The mean recipient age was 50.7±13.7 years. Sixty-three (30.3%) patients were 60 years of age or older at the time of transplantation. The mean donor age was 34.5±21.7 years. The mean cold ischemia time was 30.5±9.2 hr. The mean follow-up is 15±7 months. Results. The overall 1-year actuarial patient survival was 94%; the overall 1-year actuarial graft survival was 87%. When the patient and graft survival data were stratified to recipients under the age of 60 who did not have delayed graft function, the overall 1-year actuarial patient survival was 97%, and the corresponding 1-year actuarial graft survival was 93%. There were no differences between the two groups. The overall incidence of rejection was 36%; in the double-therapy group, it was 44%, whereas in the triple therapy group, it was 27% (P=0.014). The mean serum creatinine was 1.6±0.8 mg/dL A total of 36% of the successfully transplanted patients were taken off prednisone; 32% of the patients were taken off antihypertensive medications. The incidence of delayed graft function was 21%, the incidence of cytomegalovirus was 12.5%, and the initial and final incidences of posttransplant insulin-dependent diabetes mellitus were 7.0% and 2.9%; again, there was no difference between the two groups. Conclusions. This trial suggests that the combination of tacrolimus, steroids, and mycophenolate mofetil is associated with excellent patient and graft survival and a lower incidence of rejection than the combination of tacrolimus and steroids.
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| Item Type: |
Article
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| Status: |
Published |
| Creators/Authors: |
| Creators | Email | Pitt Username | ORCID  |
|---|
| Shapiro, R | | | | | Jordan, ML | | | | | Scantlebury, VP | | | | | Vivas, C | | | | | Marsh, JW | | | | | McCauley, J | | | | | Johnston, J | | | | | Randhawa, P | | | | | Irish, W | | | | | Gritsch, HA | | | | | Naraghi, R | | | | | Hakala, TR | | | | | Fung, JJ | | | | | Starzl, TE | tes11@pitt.edu | TES11 | |
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| Centers: |
Other Centers, Institutes, Offices, or Units > Thomas E. Starzl Transplantation Institute |
| Date: |
15 February 1999 |
| Date Type: |
Publication |
| Journal or Publication Title: |
Transplantation |
| Volume: |
67 |
| Number: |
3 |
| Page Range: |
411 - 415 |
| DOI or Unique Handle: |
10.1097/00007890-199902150-00012 |
| Institution: |
University of Pittsburgh |
| Refereed: |
Yes |
| ISSN: |
0041-1337 |
| Other ID: |
uls-drl:31735062127430, Starzl CV No. 2022 |
| Date Deposited: |
08 Apr 2010 17:34 |
| Last Modified: |
05 Feb 2019 11:55 |
| URI: |
http://d-scholarship.pitt.edu/id/eprint/5408 |
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