TY - JOUR
T1 - Long-term, prolonged-release tacrolimus-based immunosuppression in de novo kidney transplant recipients
T2 - 5-year prospective follow-up of the ADHERE study patients
AU - Rummo, O.
AU - Carmellini, M.
AU - Kamar, N.
AU - Durrbach, A.
AU - Mousson, C.
AU - Caputo, F.
AU - Mathe, Z.
AU - Christiaans, M.H.L.
AU - Kuypers, D.R.J.
AU - Klempna, U.J.
AU - Anaokar, S.
AU - Hurst, M.
AU - Kazeem, G.
AU - Undre, N.
AU - Lehner, F.
N1 - Funding Information:
This study was sponsored by Astellas Pharma Europe Ltd. Medical writing and editorial support were funded by Astellas Pharma, Inc. The authors would like to thank all centers participating in this study. This study was sponsored by Astellas Pharma Europe, Ltd. Paola Accalai and Fernando Gibson, from Cello Health MedErgy, assisted in drafting the manuscript under the direction of the authors. Editorial support was provided by Cello Health MedErgy throughout the development process. Editorial support was funded by Astellas Pharma, Inc.
Funding Information:
This study was sponsored by Astellas Pharma Europe Ltd. Medical writing and editorial support were funded by Astellas Pharma, Inc.
Funding Information:
The authors would like to thank all centers participating in this study. This study was sponsored by Astellas Pharma Europe, Ltd. Paola Accalai and Fernando Gibson, from Cello Health MedErgy, assisted in drafting the manuscript under the direction of the authors. Editorial support was provided by Cello Health MedErgy throughout the development process. Editorial support was funded by Astellas Pharma, Inc.
Publisher Copyright:
© 2019 The Authors. Transplant International published by John Wiley & Sons Ltd on behalf of Steunstichting ESOT
PY - 2020/2/1
Y1 - 2020/2/1
N2 - The objectives of this study were to assess long-term graft survival, patient survival, renal function, and acute rejections in de novo kidney transplant recipients, treated with once-daily prolonged-release tacrolimus-based therapy. The study was a 5-year non-interventional prospective follow-up of patients from the ADHERE study, a Phase IV 12-month open-label assessment of patients randomized to receive prolonged-release tacrolimus in combination with mycophenolate mofetil (MMF) (Arm 1) or sirolimus (Arm 2). From 838 patients in the randomized study, 587 were included in the long-term follow-up, of whom 510 completed the study at year 5. At 1 year post-transplant, graft and patient survival rates were 93.0% and 97.8%, respectively, and at 5 years were 84.0% and 90.8%, respectively. Cox proportional hazards analysis showed no association between graft loss, initial randomized treatment arm, donor age, donor type, or sex. The 5-year acute rejection-free survival rate was 77.4%, and biopsy-confirmed acute rejection-free survival rate was 86.0%. Renal function remained stable over the follow-up period: mean +/- SD eGFR 4-variable modification diet in renal disease formula (MDRD4) was 52.3 +/- 21.6 ml/min/1.73 m(2) at 6 months and 52.5 +/- 23.0 ml/min/1.73 m(2) at 5 years post-transplant. These findings support the role of long-term once-daily prolonged-release tacrolimus-based immunosuppression, in combination with sirolimus or MMF, for renal transplant recipients in routine clinical practice.
AB - The objectives of this study were to assess long-term graft survival, patient survival, renal function, and acute rejections in de novo kidney transplant recipients, treated with once-daily prolonged-release tacrolimus-based therapy. The study was a 5-year non-interventional prospective follow-up of patients from the ADHERE study, a Phase IV 12-month open-label assessment of patients randomized to receive prolonged-release tacrolimus in combination with mycophenolate mofetil (MMF) (Arm 1) or sirolimus (Arm 2). From 838 patients in the randomized study, 587 were included in the long-term follow-up, of whom 510 completed the study at year 5. At 1 year post-transplant, graft and patient survival rates were 93.0% and 97.8%, respectively, and at 5 years were 84.0% and 90.8%, respectively. Cox proportional hazards analysis showed no association between graft loss, initial randomized treatment arm, donor age, donor type, or sex. The 5-year acute rejection-free survival rate was 77.4%, and biopsy-confirmed acute rejection-free survival rate was 86.0%. Renal function remained stable over the follow-up period: mean +/- SD eGFR 4-variable modification diet in renal disease formula (MDRD4) was 52.3 +/- 21.6 ml/min/1.73 m(2) at 6 months and 52.5 +/- 23.0 ml/min/1.73 m(2) at 5 years post-transplant. These findings support the role of long-term once-daily prolonged-release tacrolimus-based immunosuppression, in combination with sirolimus or MMF, for renal transplant recipients in routine clinical practice.
KW - adverse drug-reactions
KW - daily prograf
KW - formulation
KW - immunosuppression
KW - kidney
KW - kidney transplant
KW - observational
KW - prolonged-release tacrolimus
KW - renal-transplantation
KW - transplant
KW - twice-daily tacrolimus
KW - TWICE-DAILY TACROLIMUS
KW - RENAL-TRANSPLANTATION
KW - ADVERSE DRUG-REACTIONS
KW - FORMULATION
KW - DAILY PROGRAF
U2 - 10.1111/tri.13527
DO - 10.1111/tri.13527
M3 - Article
C2 - 31536654
SN - 0934-0874
VL - 33
SP - 161
EP - 173
JO - Transplant International
JF - Transplant International
IS - 2
ER -