Efficacy and safety of prolonged‐release tacrolimus in stable pediatric allograft recipients converted from immediate‐release tacrolimus – a Phase 2, open‐label, single‐arm, one‐way crossover study

Author:

Rubik Jacek1,Debray Dominique2ORCID,Kelly Deirdre3,Iserin Franck4,Webb Nicholas J. A.5,Czubkowski Piotr6,Vondrak Karel7,Sellier‐Leclerc Anne‐Laure8,Rivet Christine9,Riva Silvia10,Tönshoff Burkhard11,D'Antiga Lorenzo12ORCID,Marks Stephen D.13ORCID,Reding Raymond14,Kazeem Gbenga1516,Undre Nasrullah16ORCID

Affiliation:

1. Department of Nephrology, Kidney Transplantation and Hypertension The Children's Memorial Health Institute Warsaw Poland

2. Pediatric Hepatology Unit APHP‐Hôpital Universitaire Necker Paris France

3. The Liver Unit Birmingham Women's & Children's Hospital Birmingham UK

4. Pediatric Cardiology Unit APHP‐Hôpital Universitaire Necker Paris France

5. Department of Pediatric Nephrology NIHR/Wellcome Trust Manchester Clinical Research Facility Manchester Academic Health Science Centre Royal Manchester Children's Hospital University of Manchester Manchester UK

6. Department of Gastroenterology, Hepatology, Nutritional Disturbances and Pediatrics The Children's Memorial Health Institute Warsaw Poland

7. Department of Pediatrics Second School of Medicine University Hospital Motol Charles University Prague Czech Republic

8. Department of Nephrology, Rheumatology, and Dermatology Center for Rare Diseases Civil Hospice of Lyon ‘Woman‐Mother‐Child’ Hospital Bron Cedex France

9. Pediatric Hepatology, Gastroenterology and Transplantation Civil Hospice of Lyon Lyon France

10. Department of Pediatrics ISMETT–IRCCS Palermo Italy

11. Department of Pediatrics I University Children's Hospital Heidelberg Heidelberg Germany

12. Pediatric Hepatology, Gastroenterology and Transplantation Hospital Papa Giovanni XXIII Bergamo Italy

13. Department of Pediatric Nephrology Great Ormond Street Hospital for Children NHS Foundation Trust London UK

14. Unité de Chirurgie et Transplantation Pédiatrique Cliniques Universitaires Saint-Luc Université Catholique de Louvain Brussels Belgium

15. BENKAZ Consulting Ltd Cambridge UK

16. Astellas Pharma Europe Ltd Chertsey UK

Funder

Astellas Pharma Europe

National Institute on Handicapped Research

Publisher

Frontiers Media SA

Subject

Transplantation

Reference36 articles.

1. OPTN/SRTR 2016 Annual Data Report: Liver

2. OPTN/SRTR 2016 Annual Data Report: Kidney

3. Astellas Pharma Europe Ltd.Prograf 0.5 mg 1 mg 5 mg hard capsules summary of product characteristics.https://www.medicines.org.uk/emc/product/6720. Accessed April 17 2019.

4. US Food and Drug Administration.Astagraf XL prescribing information.https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204096s005lbl.pdf. Accessed February 14 2019.

5. Astellas Pharma Europe Ltd.Advagraf 0.5 mg 1 mg 3 mg and 5 mg prolonged‐release hard capsules summary of product characteristics.https://www.medicines.org.uk/emc/product/345/smpc. Accessed February 20 2019.

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