Research Project
Project 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 |
Project Type: |
Clinical Trial, Enrolment ongoing |
Disease group(s): |
Pediatric CKD & dialysis |
Project Summary: |
Study 1517-CL-1003 is an open-label, single-arm study to evaluate Hb activity, safety, PK, PD and QoL of roxadustat in adolescents and children with anemia (associated with CKD stage 3, 4 or 5, including participants with end stage renal disease receiving hemodialysis, peritoneal dialysis or hemodiafiltration) who were previously ESA-treated or ESA-naïve. |
Lead principal investigator(s): |
Giovanni Montini, Milan |
Co-investigator(s): |
Silvia Consolo, Milan |
Project Period: |
06/2024 - 06/2050 |
Sponsors: |
Industry |
Project web page: |
https://clinicaltrials.gov/study/NCT05970172?rank=1 |
EudraCT Nr.: |
2022-501980-42 |
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