ProjectA Phase 3, Open-label, Uncontrolled Study to Evaluate the Activity, Safety, Pharmacokinetics and Pharmacodynamics…
Basic data
Title:
A Phase 3, Open-label, Uncontrolled Study to Evaluate the Activity, Safety, Pharmacokinetics and Pharmacodynamics of Roxadustat for the Treatment of Anemia in Pediatric Participants with Chronic Kidney Disease
Duration:
01/04/2024 to 31/12/2029
Abstract / short description:
ASP1517 (Roxadustat) has been approved for the treatment of adult patients with symptomatic anemia associated with Chronic Kidney Disease (CKD). This study is part of a program to develop roxadustat in the treatment of anemia in pediatric chronic kidney disease patients. In the European Union, this study is in accordance with the Pediatric Investigation Plan (PIP) approved by the Pediatric Committee (PDCO).
Keywords:
children
Kinder
erythropoetin
anemia
chronic kidney disease
Involved staff
Managers
Faculty of Medicine
University of Tübingen
University of Tübingen
Other staff
Faculty of Medicine
University of Tübingen
University of Tübingen
Local organizational units
Paediatrics Department I and Polyclinic
University Children’s Hospital - Department of Paediatrics
Hospitals and clinical institutes, Faculty of Medicine
Hospitals and clinical institutes, Faculty of Medicine
Funders
Northbrook, Illinois, United States
Cooperations
Northbrook, Illinois, United States