Detail
Article
Online article
FT
Medvik - BMC
  • Something wrong with this record ?

Outcomes with Tacrolimus-Based Immunosuppression After Kidney Transplantation from Standard- and Extended-Criteria Donors - A Post Hoc Analysis of the Prospective OSAKA Study

L. Albano, B. Banas, F. Lehner, M. Glyda, O. Viklicky, S. Schleibner, M. Brown, N. Kamar

. 2020 ; 25 (-) : e920041. [pub] 20200529

Language English Country United States

Document type Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial

Persistent link   https://www.medvik.cz/link/bmc21020539

BACKGROUND This post hoc analysis of data from the prospective OSAKA study evaluated the efficacy and safety of prolonged- and immediate-release tacrolimus in patients who received kidneys from extended-criteria (ECD) and standard-criteria (SCD) donors. MATERIAL AND METHODS Within the ECD and SCD groups, patients were randomized to one of 4 tacrolimus-based regimens (initial dose): Arm 1, immediate-release tacrolimus (0.2 mg/kg/day); Arm 2, prolonged-release tacrolimus (0.2 mg/kg/day); Arm 3, prolonged-release tacrolimus (0.3 mg/kg/day); Arm 4, prolonged-release tacrolimus (0.2 mg/kg/day) plus basiliximab. All patients received mycophenolate mofetil and bolus corticosteroids; Arms 1-3 also received tapered corticosteroids. ECDs met the definition: living/deceased donors aged ≥60 years, or 50-60 years with ≥1 other risk factor, and donation after circulatory death. Primary composite endpoint: graft loss, biopsy-confirmed acute rejection or renal dysfunction by Day 168. Outcomes were compared across treatment arms with the chi-squared or Fisher's exact test. RESULTS A total of 1198 patients were included in the analysis (ECD: n=620 [51.8%], SCD: n=578 [48.2%]). Patients with kidneys from ECDs were older versus SCDs (mean age, 55.7 vs. 44.5 years, p<0.0001). A higher proportion of patients with kidneys from ECDs versus SCDs met the primary composite endpoint (56.8% vs. 32.4%, p<0.0001). However, no statistically significant differences in clinical outcomes or the incidence of treatment-emergent adverse events were seen between treatment arms within each donor group. CONCLUSIONS Worse outcomes were experienced in patients who received kidneys from ECDs versus SCDs. Prolonged-release tacrolimus provided similar graft survival to the immediate-release formulation, with a manageable tolerability profile.

References provided by Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc21020539
003      
CZ-PrNML
005      
20210830102206.0
007      
ta
008      
210728s2020 xxu f 000 0|eng||
009      
AR
024    7_
$a 10.12659/AOT.920041 $2 doi
035    __
$a (PubMed)32467559
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxu
100    1_
$a Albano, Laetitia $u Department of Nephrology, University Hospital Center of Nice, Nice, France
245    10
$a Outcomes with Tacrolimus-Based Immunosuppression After Kidney Transplantation from Standard- and Extended-Criteria Donors - A Post Hoc Analysis of the Prospective OSAKA Study / $c L. Albano, B. Banas, F. Lehner, M. Glyda, O. Viklicky, S. Schleibner, M. Brown, N. Kamar
520    9_
$a BACKGROUND This post hoc analysis of data from the prospective OSAKA study evaluated the efficacy and safety of prolonged- and immediate-release tacrolimus in patients who received kidneys from extended-criteria (ECD) and standard-criteria (SCD) donors. MATERIAL AND METHODS Within the ECD and SCD groups, patients were randomized to one of 4 tacrolimus-based regimens (initial dose): Arm 1, immediate-release tacrolimus (0.2 mg/kg/day); Arm 2, prolonged-release tacrolimus (0.2 mg/kg/day); Arm 3, prolonged-release tacrolimus (0.3 mg/kg/day); Arm 4, prolonged-release tacrolimus (0.2 mg/kg/day) plus basiliximab. All patients received mycophenolate mofetil and bolus corticosteroids; Arms 1-3 also received tapered corticosteroids. ECDs met the definition: living/deceased donors aged ≥60 years, or 50-60 years with ≥1 other risk factor, and donation after circulatory death. Primary composite endpoint: graft loss, biopsy-confirmed acute rejection or renal dysfunction by Day 168. Outcomes were compared across treatment arms with the chi-squared or Fisher's exact test. RESULTS A total of 1198 patients were included in the analysis (ECD: n=620 [51.8%], SCD: n=578 [48.2%]). Patients with kidneys from ECDs were older versus SCDs (mean age, 55.7 vs. 44.5 years, p<0.0001). A higher proportion of patients with kidneys from ECDs versus SCDs met the primary composite endpoint (56.8% vs. 32.4%, p<0.0001). However, no statistically significant differences in clinical outcomes or the incidence of treatment-emergent adverse events were seen between treatment arms within each donor group. CONCLUSIONS Worse outcomes were experienced in patients who received kidneys from ECDs versus SCDs. Prolonged-release tacrolimus provided similar graft survival to the immediate-release formulation, with a manageable tolerability profile.
650    _2
$a dospělí $7 D000328
650    _2
$a senioři $7 D000368
650    _2
$a léky s prodlouženým účinkem $7 D003692
650    _2
$a výběr dárců $7 D046148
650    _2
$a rozvrh dávkování léků $7 D004334
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a přežívání štěpu $7 D006085
650    _2
$a lidé $7 D006801
650    _2
$a imunosupresivní léčba $7 D007165
650    _2
$a imunosupresiva $x aplikace a dávkování $7 D007166
650    _2
$a chronické selhání ledvin $x chirurgie $7 D007676
650    12
$a transplantace ledvin $7 D016030
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a lidé středního věku $7 D008875
650    _2
$a prospektivní studie $7 D011446
650    _2
$a takrolimus $x aplikace a dávkování $7 D016559
650    _2
$a výsledek terapie $7 D016896
655    _2
$a klinické zkoušky, fáze III $7 D017428
655    _2
$a časopisecké články $7 D016428
655    _2
$a randomizované kontrolované studie $7 D016449
700    1_
$a Banas, Bernard $u Department of Nephrology, University Medical Center Regensburg, Regensburg, Germany
700    1_
$a Lehner, Frank $u Department of General, Visceral and Transplantation Surgery, Hannover Medical School, Hannover, Germany
700    1_
$a Glyda, Maciej $u Department of Transplantology and Surgery, District Public Hospital, Poznań, Poland $u Nicolaus Copernicus University College of Medicine, Bydgoszcz, Poland
700    1_
$a Viklicky, Ondrej $u Department of Nephrology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic
700    1_
$a Schleibner, Stefan $u Formerly Astellas Pharma GmbH, Munich, Germany
700    1_
$a Brown, Malcolm $u Medical Affairs, Astellas Pharma Global Development, Inc., Northbrook, IL, USA
700    1_
$a Kamar, Nassim $u Department of Nephrology and Organ Transplantation, CHU Rangueil, Paul Sabatier University, INSERM U10403, Toulouse, France
773    0_
$w MED00000447 $t Annals of transplantation $x 2329-0358 $g Roč. 25, č. - (2020), s. e920041
856    41
$u https://pubmed.ncbi.nlm.nih.gov/32467559 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y p $z 0
990    __
$a 20210728 $b ABA008
991    __
$a 20210830102206 $b ABA008
999    __
$a ok $b bmc $g 1691167 $s 1140985
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2020 $b 25 $c - $d e920041 $e 20200529 $i 2329-0358 $m Annals of Transplantation $n Ann Transplant $x MED00000447
LZP    __
$a Pubmed-20210728

Find record

Citation metrics

Archiving options