A prospective 3-yr evaluation of tacrolimus-based immunosuppressive therapy in immunological high risk renal allograft recipients

• Published in: Clinical transplantation 2005-02, Vol.19 (1), p.26-32
• Main Authors: Zaltzman, Jeffrey S., Boucher, Anne, Busque, Stephan, Halloran, Phillip F., Landsberg, David N., McAlister, Vivian C., Russell, David, Shoker, Ahmed, Shapiro, Jean, Tchervenkov, Jean I., Ferguson, Ralph
• Format: Article
• Language: English
• Subjects: Adult; Aged; Biological and medical sciences; Cardiology. Vascular system; cytomegalovirus; delayed graft function; Female; Graft Rejection - immunology; Graft Survival - drug effects; high risk; Humans; immunosuppression; Immunosuppressive Agents - immunology; Immunosuppressive Agents - therapeutic use; Kidney Transplantation - immunology; Male; Medical sciences; Middle Aged; Nephrology. Urinary tract diseases; Prospective Studies; renal transplantation; sensitized; Survival Analysis; Tacrolimus - immunology; Tacrolimus - therapeutic use; Treatment Outcome
• ISSN: 0902-0063; 1399-0012
• DOI: 10.1111/j.1399-0012.2005.00275.x

:  Background:  There have been no published data on use of the the newer immunosuppressants tacrolimus and mycophenolate mofetil (MMF) in high immunological risk renal transplantation. We therefore undertook a prospective study to systematically assess outcomes using these agents as part of an aggressive immunosuppressive regimen. Methods:  Fifty‐nine high‐risk renal allograft recipients were enrolled at 10 Canadian sites and given a regimen of: a biological induction agent, tacrolimus, MMF, and corticosteroids. Patients included 10 (17%) who had lost a previous graft to rejection 30%, 47 (80%) with a historic PRA >50%, four (7%) who had a positive historical T‐cell crossmatch with the current donor, and six (10%) with a current positive B‐cell crossmatch. The mean peak PRA was 76 ± 33%. Results:  The estimated 3‐yr Kaplan–Meier patient and graft survival estimates were 89% and 75%, respectively. There were nine graft losses other than deaths with a functioning graft, of which six were preceded by delayed graft function (p = 0.01, χ2). Sixteen (27%) recipients experienced at least one episode of biopsy‐confirmed acute rejection. Infections included cytomegalovirus in 16 patients, eight of whom had tissue‐invasive disease. Only one malignancy occurred. Conclusions:  The immunosuppressive strategy investigated is effective and displays a satisfactory safety profile in high immunological risk renal allograft recipients.