ImmunosuppressionCalcineurin inhibitorsA 39-Month Follow-up Study to Evaluate the Safety and Efficacy in Kidney Transplant Recipients Treated With Modified-Release Tacrolimus (FK506E)-Based Immunosuppression Regimen
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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De novo kidney transplant recipients need higher doses of Advagraf compared with Prograf to get therapeutic levels
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Tacrolimus once daily (ADVAGRAF) versus twice daily (PROGRAF) in de novo renal transplantation: a randomized phase III study
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Cited by (12)
Expression of receptor activator of nuclear factor-kappa B ligand in leukocytes during acute kidney rejection after transplantation in rats
2013, Transplantation ProceedingsCitation Excerpt :To date, graft biopsy with pathohistologic analysis is the only reliable procedure to determine the presence of acute cellular rejection and to distinguish humoral rejection or acute tubular necrosis.2,3,7,8 The determination of renal allograft pathology has crucial clinical and therapeutic implications.7,8 Since kidney graft biopsy is potentially harmful both for patients and for the transplanted kidney, it is an imperative to find a less invasive method.9
Efficacy and safety of once-daily prolonged-release tacrolimus versus twice-daily tacrolimus in kidney transplant recipients: A meta-analysis and trial sequential analysis
2023, Journal of the Chinese Medical AssociationExtended release versus immediate release tacrolimus in kidney transplant recipients: a systematic review and meta-analysis
2018, European Journal of Clinical PharmacologyAdvagraf® with or without an induction therapy for de novo kidney-transplant recipients
2018, Expert Review of Clinical Immunology
This study was funded by Astellas Pharma Korea.