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The Effect of Donor Age and Recipient Characteristics on Renal Outcomes in Patients Receiving Prolonged-Release Tacrolimus After Liver Transplantation: Post-Hoc Analyses of the DIAMOND Study

P. Trunečka, J. Klempnauer, WO. Bechstein, J. Pirenne, W. Bennet, A. Zhao, H. Isoniemi, L. Rostaing, U. Settmacher, C. Mönch, M. Brown, N. Undre, G. Kazeem, G. Tisone,

. 2019 ; 24 (-) : 319-327. [pub] 20190604

Jazyk angličtina Země Spojené státy americké

Typ dokumentu časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/bmc20006291

BACKGROUND The DIAMOND study of de novo liver transplant patients showed that prolonged-release tacrolimus exposure in the acute post-transplant period maintained renal function over 24 weeks of treatment. To assess these findings further, we performed a post-hoc analysis in patients according to baseline kidney function, Model for End-stage Liver Disease [MELD] scores, and donor age. MATERIAL AND METHODS Patients received prolonged-release tacrolimus (initial-dose, Arm 1: 0.2 mg/kg/day, Arm 2: 0.15-0.175 mg/kg/day, Arm 3: 0.2 mg/kg/day delayed until Day 5), mycophenolate mofetil and 1 steroid bolus. Arms 2 and 3 also received basiliximab. The recommended tacrolimus target trough levels to Day 42 post-transplantation were 5-15 ng/mL in all arms. In this post-hoc analysis, change in renal outcome, based on estimated glomerular filtration rate (eGFR), Modified Diet in Renal Disease-4 (MDRD4), values from baseline to Week 24 -post-transplantation, were assessed according to baseline patient factors: eGFR (≥60 and ˂60 mL/min/1.73 m²), MELD score (˂25 and ≥25) and donor age (˂50 and ≥50 years). RESULTS Baseline characteristics were comparable (Arms 1-3: n=283, n=287, n=274, respectively). Patients with baseline renal function, eGFR ≥60 mL/min/1.73 m², experienced a decrease in eGFR in all tacrolimus treatment arms. In patients with lower baseline renal function (eGFR ˂60 mL/min/1.73 m²), an advantage for renal function was observed with both the early lower-dose and delayed higher-dose tacrolimus regimens compared with the early introduction of higher-dose tacrolimus. At Week 24, renal function was higher in the early-lower tacrolimus arm with older donors, and the delayed higher-dose tacrolimus arm with younger donors, both compared with early higher-dose tacrolimus. CONCLUSIONS Pre-transplantation factors, such as renal function and donor age, could guide the choice of prolonged-release tacrolimus regimen following liver transplantation.

Citace poskytuje Crossref.org

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$a BACKGROUND The DIAMOND study of de novo liver transplant patients showed that prolonged-release tacrolimus exposure in the acute post-transplant period maintained renal function over 24 weeks of treatment. To assess these findings further, we performed a post-hoc analysis in patients according to baseline kidney function, Model for End-stage Liver Disease [MELD] scores, and donor age. MATERIAL AND METHODS Patients received prolonged-release tacrolimus (initial-dose, Arm 1: 0.2 mg/kg/day, Arm 2: 0.15-0.175 mg/kg/day, Arm 3: 0.2 mg/kg/day delayed until Day 5), mycophenolate mofetil and 1 steroid bolus. Arms 2 and 3 also received basiliximab. The recommended tacrolimus target trough levels to Day 42 post-transplantation were 5-15 ng/mL in all arms. In this post-hoc analysis, change in renal outcome, based on estimated glomerular filtration rate (eGFR), Modified Diet in Renal Disease-4 (MDRD4), values from baseline to Week 24 -post-transplantation, were assessed according to baseline patient factors: eGFR (≥60 and ˂60 mL/min/1.73 m²), MELD score (˂25 and ≥25) and donor age (˂50 and ≥50 years). RESULTS Baseline characteristics were comparable (Arms 1-3: n=283, n=287, n=274, respectively). Patients with baseline renal function, eGFR ≥60 mL/min/1.73 m², experienced a decrease in eGFR in all tacrolimus treatment arms. In patients with lower baseline renal function (eGFR ˂60 mL/min/1.73 m²), an advantage for renal function was observed with both the early lower-dose and delayed higher-dose tacrolimus regimens compared with the early introduction of higher-dose tacrolimus. At Week 24, renal function was higher in the early-lower tacrolimus arm with older donors, and the delayed higher-dose tacrolimus arm with younger donors, both compared with early higher-dose tacrolimus. CONCLUSIONS Pre-transplantation factors, such as renal function and donor age, could guide the choice of prolonged-release tacrolimus regimen following liver transplantation.
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$a Klempnauer, Jürgen $u Department of General-, Visceral- and Transplantation Surgery, Hannover Medical School, Hannover, Germany.
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$a Bechstein, Wolf Otto $u Department of Surgery, Goethe University Hospital and Clinics, Frankfurt, Germany.
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$a Pirenne, Jacques $u Abdominal Transplant Surgery, University Hospitals Leuven, Leuven, Belgium.
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$a Bennet, William $u The Transplant Institute, Sahlgrenska University Hospital, Gothenburg, Sweden.
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$a Zhao, Alexey $u Department of Abdominal Surgery, A.V. Vishnevsky Institute of Surgery, Moscow, Russian Federation.
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$a Isoniemi, Helena $u Department of Transplantation and Liver Surgery Clinic, Helsinki University Hospital, Helsinki, Finland.
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$a Rostaing, Lionel $u Department of Nephrology and Organ Transplantation, Toulouse University Hospital, Toulouse, France.
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$a Settmacher, Utz $u Department of General, Visceral and Vascular Surgery, Jena University Hospital, Jena, Germany.
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$a Mönch, Christian $u Department of Surgery, Goethe University Hospital and Clinics, Frankfurt, Germany. Department of General, Visceral and Transplantation Surgery, Westpfalz-Klinikum Hospital, Kaiserslautern, Germany.
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$a Brown, Malcolm $u Astellas Pharma, Medical Affairs - Global, Northbrook, IL, USA.
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$a Undre, Nasrullah $u Astellas Pharma Europe Ltd., Chertsey, United Kingdom.
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$a Kazeem, Gbenga $u Astellas Pharma Europe Ltd., Chertsey, United Kingdom. BENKAZ Consulting Ltd., Cambridge, United Kingdom.
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$a Tisone, Giuseppe $u Transplant and Hepatobiliary Unit, Department of Surgery, University of Rome Tor Vergata, Rome, Italy.
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