| Autor: |
Mark D. Pescovitz, John B. Copley, Donald E. Hricik, John Dunn, J. Harold Helderman, Stephen Rose, J. Andrew Bertolatus, Harold C-Yang, John F. Neylan, Matthew McIntosh, Thomas A. Gonwa, S. Tomlanovich, Daniel H. Hayes, Alan H. Wilkinson, James J. Wynn, Arthur J. Matas, Nasimul Ahsan, Karl Brinler, Mathew R. Weir, Lawrence Chan, John D. Pirsch, Ernest E. Hodge, Donald Stablein, David M. Cohen, Stephen J. Tomlanovich, Robert C. Harland, Robert Mendez, Marian Ewell, William M. Bennett, Paul F. Gores |
| Rok vydání: |
1999 |
| Předmět: |
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| Zdroj: |
Transplantation. 68:1865-1874 |
| ISSN: |
0041-1337 |
| DOI: |
10.1097/00007890-199912270-00009 |
| Popis: |
BACKGROUND Prospective randomized trials have shown a reduced rate of acute rejection (AR) in mycophenolate mofetil-treated kidney transplant recipients. We hypothesized that this increased protection from AR could allow successful prednisone (P) withdrawal in cyclosporine/mycophenolate mofetil/P-treated recipients. METHODS A multicenter, prospective, randomized, double-blind trial of P withdrawal at 3 months post-transplant was initiated. Entry criteria were: primary transplant, adult, no AR by 90 days, mycophenolate mofetil dose > or =2 g/day, cyclosporine dose = 5-15 mg/kg/ day, P dose = 10-15 mg/day. Study participants were randomized to have P tapered over 8 weeks (beginning at 3 months posttransplant) to 0 vs. 10 mg/day. Prestudy power analysis determined 500 recipients should be randomized for 80% statistical power to test equivalence of the primary endpoint, AR, or treatment failure at 1 year posttransplant. By design, the study was to be stopped if interim data precluded reaching equivalence. An established data safety monitoring board monitored the study. RESULTS After 266 patients were enrolled, the patient enrollment was stopped (after safety monitoring board review) because of excess rejection in the P withdrawal group. The Kaplan-Meier estimate of the cumulative incidence of rejection or treatment failure within 1 year posttransplant (+/-95% confidence interval) for the maintenance group was 9.8% (4.4%; treatment failure, 14.9%); for the withdrawal group, 30.8% (21.0%; 39.3%). Treatment differences in the distribution of time to event were highly significant (P = 0.0007). Of note, risk was higher in blacks (39.6%) versus nonblacks (16.0%) (P |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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