A 6-month, multicenter, single-arm pilot study to evaluate the efficacy and safety of generic tacrolimus (TacroBell) after primary renal transplantation.
OBJECTIVE
Tacrolimus has been shown to be an important immunosuppressive agent in organ and bone marrow transplantation. Previously, we reported that there were no statistically significant differences between the pharmacokinetic parameters of the oral formulation of generic tacrolimus (TacroBell) and the conventional formulation (Prograf). This study was designed to evaluate the efficacy and safety of oral capsules of TacroBell in de novo renal transplantation.


METHODS
Ninety-six renal transplant recipients from 9 transplantation centers in South Korea were enrolled between November 2005 and July 2007. De novo renal recipients ranged from 19-65 years old. Ninety-four patients who underwent renal transplantation were administered study drug at least one time in the intent-to-treat (ITT) analysis. This phase 4 clinical trial was a 26-week, open-label, noncomparative, multicenter study.


RESULTS
An acute rejection episode developed in 10/94 recipients (10.6%, 95% confidence interval, 4.4%-16.9%). There were no patient deaths during the study. The 6-month graft survival rate was 96.8%.


CONCLUSIONS
Based on this study, treatment with TacroBell is considered to be efficient and safe after primary renal transplantation.
Kim
S J
SJ
Department of Transplantation Surgery, Severance Hospital Transplantation Center, Yonsei University Health System, Seoul, Korea.
Huh
K H
KH
Han
D-J
DJ
Moon
I S
IS
Kim
S-J
SJ
Kim
Y-L
YL
Kim
H C
HC
Lee
S
S
Kang
C-M
CM
Cho
B-H
BH
Kim
Y S
YS
D000328:Adult; D003404:Creatinine / Q000097:blood; D016568:Drugs, Generic / Q000627:therapeutic use; D006084:Graft Rejection / Q000453:epidemiology; D006801:Humans; D006937:Hypercholesterolemia / Q000453:epidemiology; D015228:Hypertriglyceridemia / Q000453:epidemiology; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D016030:Kidney Transplantation / Q000276:immunology*; D008875:Middle Aged; D010865:Pilot Projects; D011183:Postoperative Complications / Q000453:epidemiology / Q000276:immunology; D012449:Safety; D016559:Tacrolimus / Q000627:therapeutic use*
D016568:Drugs, Generic; D007166:Immunosuppressive Agents; D003404:Creatinine; D016559:Tacrolimus