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ORIGINAL ARTICLE
Year : 2017  |  Volume : 11  |  Issue : 2  |  Page : 70-76

Immunosuppression with prolonged-release tacrolimus in kidney or liver transplantation in India


1 Nephrology and Kidney Transplant Medicine, Sir Ganga Ram Hospital, New Delhi, Delhi, India
2 Department of Nephrology, Care Hospitals, Hyderabad, Telangana, India
3 Department of Nephrology, Apollo Hospitals, Chennai, India
4 Department of Nephrologyand Dialysis, Jaslok Hospital and Research Centre, Mumbai, Maharashtra, India
5 Department of Nephrology, Christian Medical College, Vellore, Tamil Nadu, India
6 Department of Nephrology, P.D. Hinduja National Hospital and Medical Research Centre, Mumbai, Maharashtra, India
7 Department of Medical and Development, Astellas Pharma Pvt Ltd., Mumbai, Maharashtra, India

Correspondence Address:
Dinesh Khullar
Nephrology and Renal Transplant Medicine, Max Super Speciality Hospital, Saket, New Delhi - 110 017
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijot.ijot_2_17

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Aim: Tacrolimus has proven efficacy as an immunosuppressive therapy to prevent transplant rejection and is widely used as an immediate-release formulation in a twice-daily regimen. Once-daily prolonged-release tacrolimus aims to improve the outcomes by reducing variability in exposure and improving adherence. However, there are limited published data available on prolonged-release tacrolimus in routine clinical practice in India. Methods: This was a Phase IV, multicenter, prospective study of prolonged-release tacrolimus conducted over 12 weeks in adult patients eligible for de novo kidney or liver transplantation in India. Primary efficacy end-point was the event rate of biopsy-confirmed acute rejections (BCARs). Secondary end-points included corticosteroid-resistant rejection incidence, time to first BCAR, graft loss, and death. Safety end-points included renal function, lipid profile, incidence of new-onset diabetes mellitus after transplantation (NODAT), and infection. Results: The study enrolled 92 patients undergoing kidney (81 [88.0%]) or liver transplantation (11 [12.0%]); a total of 76 patients (82.6%) completed the study. Ten kidney transplant patients (overall 10.9%) experienced BCAR. There were seven corticosteroid-sensitive and three corticosteroid-resistant rejections. Median (range) time to kidney transplant rejection was 6.5 (1.0–76.0) days. Renal function was stable or improved. Lipid levels showed a significant increase. Eleven instances of NODAT and seven infections occurred and there were eight deaths (8.7%; six kidney and two liver transplant patients). Conclusions: In de novo kidney and liver transplant recipients in India, prolonged-release tacrolimus was well-tolerated and efficacious with a low incidence of acute rejection. Safety profile was similar to immediate-release tacrolimus from published data.


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