-
Something wrong with this record ?
Comparative pharmacokinetics of tacrolimus in de novo pediatric transplant recipients randomized to receive immediate- or prolonged-release tacrolimus
K. Vondrak, A. Dhawan, F. Parisi, R. Grenda, D. Debray, SD. Marks, NJA. Webb, A. Lachaux, G. Kazeem, N. Undre,
Language English Country Denmark
Document type Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
PubMed
30358019
DOI
10.1111/petr.13289
Knihovny.cz E-resources
- MeSH
- Allografts MeSH
- Child MeSH
- Infant MeSH
- Delayed-Action Preparations MeSH
- Humans MeSH
- Linear Models MeSH
- Adolescent MeSH
- Pediatrics methods MeSH
- Area Under Curve MeSH
- Child, Preschool MeSH
- Tacrolimus administration & dosage pharmacokinetics MeSH
- Liver Transplantation * MeSH
- Kidney Transplantation * MeSH
- Heart Transplantation * MeSH
- Check Tag
- Child MeSH
- Infant MeSH
- Humans MeSH
- Adolescent MeSH
- Male MeSH
- Child, Preschool MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase II MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
Phase 2, parallel-group, multicenter, open-label, 4-week study, comparing PK of PR-T vs IR-T in de novo pediatric patients undergoing primary kidney, liver, or heart transplantation. Patients randomized 1:1 to receive once daily, PR-T-, or twice-daily, IR-T-based regimens; dose adjustments permitted after Day 1. Twenty-four-hour PK profiles collected on Days 1, 7, and 28. Primary endpoint: tacrolimus AUC24 . Secondary end points included tacrolimus C24 and Cmax . Endpoints compared between PR-T and IR-T on Days 1, 7, and 28. Predefined similarity interval for CIs of LSM ratios: 80%-125%. PK analysis set comprised 33 patients (PR-T, n = 15; IR-T, n = 18). Overall, AUC24 and Cmax were lower on Day 1 vs 7 and 28. Geometric LSM ratios of PR-T:IR-T on Days 1, 7, and 28 were 66.3%, 92.5%, 99.9%, respectively, for AUC24 ; 66.3%, 82.2%, 90.9% for C24 ; and 77.3%, 120.3%, 92.2% for Cmax . AUC24 90% CI within predefined similarity interval on Day 28; other 90% CIs fell outside. Linear relationship was similar between AUC24 and C24 , and between tacrolimus formulations, suggesting that the same therapeutic drug monitoring method can be used with both formulations in de novo pediatric allograft recipients.
Astellas Pharma Europe Ltd Chertsey UK
Astellas Pharma Europe Ltd Chertsey UK BENKAZ Consulting Ltd Cambridge UK
Paediatric Liver GI and Nutrition Center King's College Hospital London UK
Pediatric Hepatology Unit APHP Hôpital Universitaire Necker Enfants Malades Paris France
References provided by Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc19012225
- 003
- CZ-PrNML
- 005
- 20190416111616.0
- 007
- ta
- 008
- 190405s2018 dk f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1111/petr.13289 $2 doi
- 035 __
- $a (PubMed)30358019
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a dk
- 100 1_
- $a Vondrak, Karel $u Department of Pediatrics, University Hospital Motol, Second School of Medicine, Charles University, Prague, Czech Republic.
- 245 10
- $a Comparative pharmacokinetics of tacrolimus in de novo pediatric transplant recipients randomized to receive immediate- or prolonged-release tacrolimus / $c K. Vondrak, A. Dhawan, F. Parisi, R. Grenda, D. Debray, SD. Marks, NJA. Webb, A. Lachaux, G. Kazeem, N. Undre,
- 520 9_
- $a Phase 2, parallel-group, multicenter, open-label, 4-week study, comparing PK of PR-T vs IR-T in de novo pediatric patients undergoing primary kidney, liver, or heart transplantation. Patients randomized 1:1 to receive once daily, PR-T-, or twice-daily, IR-T-based regimens; dose adjustments permitted after Day 1. Twenty-four-hour PK profiles collected on Days 1, 7, and 28. Primary endpoint: tacrolimus AUC24 . Secondary end points included tacrolimus C24 and Cmax . Endpoints compared between PR-T and IR-T on Days 1, 7, and 28. Predefined similarity interval for CIs of LSM ratios: 80%-125%. PK analysis set comprised 33 patients (PR-T, n = 15; IR-T, n = 18). Overall, AUC24 and Cmax were lower on Day 1 vs 7 and 28. Geometric LSM ratios of PR-T:IR-T on Days 1, 7, and 28 were 66.3%, 92.5%, 99.9%, respectively, for AUC24 ; 66.3%, 82.2%, 90.9% for C24 ; and 77.3%, 120.3%, 92.2% for Cmax . AUC24 90% CI within predefined similarity interval on Day 28; other 90% CIs fell outside. Linear relationship was similar between AUC24 and C24 , and between tacrolimus formulations, suggesting that the same therapeutic drug monitoring method can be used with both formulations in de novo pediatric allograft recipients.
- 650 _2
- $a mladiství $7 D000293
- 650 _2
- $a alografty $7 D064591
- 650 _2
- $a plocha pod křivkou $7 D019540
- 650 _2
- $a dítě $7 D002648
- 650 _2
- $a předškolní dítě $7 D002675
- 650 _2
- $a léky s prodlouženým účinkem $7 D003692
- 650 _2
- $a ženské pohlaví $7 D005260
- 650 12
- $a transplantace srdce $7 D016027
- 650 _2
- $a lidé $7 D006801
- 650 _2
- $a kojenec $7 D007223
- 650 12
- $a transplantace ledvin $7 D016030
- 650 _2
- $a lineární modely $7 D016014
- 650 12
- $a transplantace jater $7 D016031
- 650 _2
- $a mužské pohlaví $7 D008297
- 650 _2
- $a pediatrie $x metody $7 D010372
- 650 _2
- $a takrolimus $x aplikace a dávkování $x farmakokinetika $7 D016559
- 655 _2
- $a klinické zkoušky, fáze II $7 D017427
- 655 _2
- $a srovnávací studie $7 D003160
- 655 _2
- $a časopisecké články $7 D016428
- 655 _2
- $a multicentrická studie $7 D016448
- 655 _2
- $a randomizované kontrolované studie $7 D016449
- 655 _2
- $a práce podpořená grantem $7 D013485
- 700 1_
- $a Dhawan, Anil $u Paediatric Liver GI and Nutrition Center, King's College Hospital, London, UK.
- 700 1_
- $a Parisi, Francesco $u Department of Pediatric Cardiology and Cardiac Surgery, Thoracic Transplant Unit, Osp Pediatrico Bambino Gesù, Rome, Italy.
- 700 1_
- $a Grenda, Ryszard $u Department of Nephrology and Kidney Transplantation, The Children's Memorial Health Institute, Warsaw, Poland.
- 700 1_
- $a Debray, Dominique $u Pediatric Hepatology Unit, APHP-Hôpital Universitaire Necker-Enfants Malades, Paris, France.
- 700 1_
- $a Marks, Stephen D $u Department of Paediatric Nephrology, Great Ormond Street Hospital for Children, NHS Foundation Trust, London, UK.
- 700 1_
- $a Webb, Nicholas J A $u Department of Paediatric Nephrology, Royal Manchester Children's Hospital, Manchester University Foundation Trust, Manchester, UK.
- 700 1_
- $a Lachaux, Alain $u Service d'Hépatologie Pédiatrique, Université Lyon 1 et Hospices Civils de Lyon, HFME, Bron Cedex, France.
- 700 1_
- $a Kazeem, Gbenga $u Astellas Pharma Europe Ltd, Chertsey, UK. BENKAZ Consulting Ltd, Cambridge, UK.
- 700 1_
- $a Undre, Nasrullah $u Astellas Pharma Europe Ltd, Chertsey, UK.
- 773 0_
- $w MED00004924 $t Pediatric transplantation $x 1399-3046 $g Roč. 22, č. 8 (2018), s. e13289
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/30358019 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y a $z 0
- 990 __
- $a 20190405 $b ABA008
- 991 __
- $a 20190416111641 $b ABA008
- 999 __
- $a ok $b bmc $g 1391535 $s 1050530
- BAS __
- $a 3
- BAS __
- $a PreBMC
- BMC __
- $a 2018 $b 22 $c 8 $d e13289 $e 20181024 $i 1399-3046 $m Pediatric transplantation $n Pediatr. transplant. (Online) $x MED00004924
- LZP __
- $a Pubmed-20190405
