Two-year observation of a randomized trial on tacrolimus-based therapy with withdrawal of steroids or mycophenolate mofetil after renal transplantation.
OBJECTIVE
To evaluate the safety and feasibility of steroid or mycophenolate mofetil (MMF) withdrawal from tacrolimus-based immunosuppressant regimen in renal allograft recipients.


METHODS
A cohort of 45 patients following cadaveric renal allograft transplantation were randomly divided into 3 groups based on the regimen of combination of tacrolimus, steroid, and MMF: triple therapy group, steroid withdrawal group, and MMF withdrawal group. During 2 years, survival of patients and allografts, clinical acute rejection, adverse events, hepatic and renal allograft function, and blood lipids were monitored to evaluate the safety and feasibility of steroid or MMF withdrawal after renal transplantation.


RESULTS
During two-year observation, steroid or MMF was successfully withdrawn from immunosuppressant regimen based on tacrolimus without any clinical acute rejection. Patient and graft survival rates were 100% and all the renal allografts kept excellent function. Some adverse events occurred and there were no significant differences among groups.


CONCLUSIONS
Withdrawal of steroid or MMF in low-immunological-risk renal allografts treated with tacrolimus-based immunosuppressant regimen can be achieved with no increased risk of acute rejection.
Zhu
Qing-guo
QG
Department of Urinary Surgery, the Second Affiliated Hospital of Harbin Medical University, Harbin 150086.
Zhao
Ya-kun
YK
Liu
Wei
W
Luo
Hui
H
Qiu
Yu
Y
Gao
Zhi-zhong
ZZ
D000328:Adult; D000368:Aged; D004359:Drug Therapy, Combination; D006084:Graft Rejection / Q000188:drug therapy / Q000517:prevention & control; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016030:Kidney Transplantation / Q000009:adverse effects / Q000276:immunology; D008055:Lipids / Q000097:blood; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011446:Prospective Studies; D013256:Steroids / Q000627:therapeutic use*; D016559:Tacrolimus / Q000627:therapeutic use*; D014184:Transplantation, Homologous / Q000276:immunology
D007166:Immunosuppressive Agents; D008055:Lipids; D013256:Steroids; D009173:Mycophenolic Acid; D016559:Tacrolimus