Tacrolimus (Pan Graf) in live related renal transplantation: an initial experience of 101 recipients in India.
BACKGROUND
Success of modern transplantation is in large part due to the successful development of effective immunosuppressive agents. The safety and efficacy of tacrolimus in transplantation is well established. However, tacrolimus (Pan Graf, Panacea Biotec Ltd, India) has only been available in India for the last 2 years. This study was conducted to assess the safety and efficacy of tacrolimus in live related kidney transplantation. We report an initial experience of tacrolimus as de novo therapy in a live related renal transplantation program.


METHODS
One hundred one consecutive recipients of a live renal allograft were commenced on triple immunosuppression consisting of tacrolimus, mycophenolate mofetil or azathioprine, and steroids. The dose of tacrolimus was adjusted to keep trough levels at 10-12 ng/mL in the first 3 months, 8-10 ng/mL in the next 3 months, and 5-8 ng/mL thereafter. All patients were followed up for a period ranging from 4 weeks to 24 months. The effect of this regimen on the incidence of graft rejection, graft survival, patient survival, and new-onset diabetes mellitus was evaluated. Any evidence of graft dysfunction was evaluated using a graft biopsy.


RESULTS
There were 89 male and 12 female patients with mean age of 32.08 years. The incidence of acute rejection was 3.96%; 21.05% developed new-onset diabetes mellitus. Six patients were diabetic prior to transplantation and 9 patients were hepatitis C virus (HCV)-positive; 77.7% of HCV-positive patients and 15.1% of HCV-negative patients developed posttransplantation diabetes mellitus. The patient survival rate at the current follow-up was 92.07%. No graft was lost due to rejection.


CONCLUSIONS
Tacrolimus is a safe and effective immunosuppressant in live related renal transplantation.
Guleria
S
S
Department of Surgery and Nephrology and Pathology, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India, and Panacea Biotec India Ltd. sandeepguleria@hotmail.com
Kamboj
M
M
Sharma
M
M
Chatterjee
A
A
Dinda
A
A
Chaudhary
A
A
Mahajan
S
S
Gupta
S
S
Bhowmik
D
D
Agarwal
S K
SK
Tiwari
S C
SC
Dash
S C
SC
D000293:Adolescent; D000328:Adult; D001379:Azathioprine / Q000627:therapeutic use; D002648:Child; D004359:Drug Therapy, Combination; D005190:Family; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016030:Kidney Transplantation / Q000276:immunology* / Q000401:mortality; D019520:Living Donors; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use; D012189:Retrospective Studies; D016019:Survival Analysis; D016559:Tacrolimus / Q000627:therapeutic use*
D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid; D001379:Azathioprine; D016559:Tacrolimus