Elsevier

Transplantation Proceedings

Volume 44, Issue 1, January–February 2012, Pages 115-117
Transplantation Proceedings

Immunosuppression
Calcineurin inhibitors
A 39-Month Follow-up Study to Evaluate the Safety and Efficacy in Kidney Transplant Recipients Treated With Modified-Release Tacrolimus (FK506E)-Based Immunosuppression Regimen

https://doi.org/10.1016/j.transproceed.2011.12.070Get rights and content

Abstract

Background

We initially performed a study to evaluate the safety and efficacy of modified-release tacrolimus (FK506E) in a phase 3, 2-arm, 6-month, randomized, open-label, multicenter trial in Korean living donor de novo kidney transplant recipients. We then performed an extended study to evaluate the long-term safety and efficacy of a FK506E-based regimen up to 45 months posttransplantation in recipients already treated with FK506E.

Methods

Initial study was designed as a randomized, open-label, comparative, multicenter study in de novo living donor kidney transplant recipients. The patients were randomized to an FK506E versus a control (FK506) group (1:1). Recipients who completed a 6-month FK506E treatment study were enrolled in the 39-month follow-up study. Primary end-points were patient and graft survivals at posttransplantation 45 months. Secondary end-point was the incidence of a clinical or biopsy-proven acute rejection episode between 6 and 45 months posttransplantation.

Results

In the initial 6-month de novo study 124 enrolled patients were randomized into either the FK506E (n = 62) or the control group (n = 62). The incidence of an acute rejection episode was 19.4% (n = 12) in the FK506E versus 16.1% (n = 10) in the control group (P = .638). There was no mortality or graft failure among the 44 recipients enrolled in this additional 39-month follow-up study. There was 1 patient with biopsy-proven acute cellular rejection episode (2.3%) who underwent steroid pulse therapy with renal function recovery. At the time of study completion 40/44 recipients (90.9%) maintained FK506E treatment.

Conclusion

This 39-month study following the initial 6-month FK506E study period showed an FK506E-based immunosuppressive regimen in living donor kidney transplantation recipients to be safe and effective.

Section snippets

The 6-Month De Novo Study

The initial study was designed as a phase 3, randomized, open-label, comparative, multicenter study in de novo living donor kidney transplant recipients. Inclusion criteria were recipients of a primary, living donor kidney transplant at ages 19–6 years. Exclusion criteria were a previous organ transplantation, an ABO incompatible donor, a routine or non–heart-beating–cadaveric donor, recipient or donor with a positive test for human immunodeficiency virus (HIV), uncontrolled concomitant or

The De Novo 6-Month Study

Between January 2006 and January 2007, we enrolled and randomized 124 patients into the FK506E (n = 62) and the control groups (n = 62) for the initial 6-month de novo study. Basal characteristics of the patients are shown in Table 1. The incidence rate of an acute rejection episode was 19.4% (n = 12) in the FK506E group and 16.1% (n = 10) in the control group (P = .638). Regarding antilymphocyte antibody treatment, there were 2 episodes in the FK506E and none de in the control group (P =

Discussion

Pharmacokinetic profiles of long-acting FK506E compared with FK506 have been studied previously in a short-term study.3 In this multicenter, prospective, randomized study comparing FK506E with FK506, de novo use of FK506E with MMF and steroid showed a comparable results to FK506 at 6 months in terms of acute rejection episodes (19.4% vs 16.1%), renal function (Creatinine 1.3 mg/dL) as well as patient (100% vs 98.4%) and graft survivals rates (100% vs 98.4%). These results are similar to

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This study was funded by Astellas Pharma Korea.

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