• Users Online: 329
  • Print this page
  • Email this page
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
Login to access the Email id

Source of Support: None, Conflict of Interest: None

DOI: 10.4103/ijot.ijot_2_17

Get Permissions

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.

Print this article     Email this article
 Next article
 Previous article
 Table of Contents

 Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
 Citation Manager
 Access Statistics
 Reader Comments
 Email Alert *
 Add to My List *
 * Requires registration (Free)

 Article Access Statistics
    PDF Downloaded123    
    Comments [Add]    

Recommend this journal