GSK-201754

Study Sponsor: GSK

Study Title

A 52-week, Phase III, double-blind, active-controlled, parallel-group, multi-center study to evaluate efficacy and safety of daprodustat compared to darbepoetin alfa in Japanese hemodialysis-dependent subjects with anemia associated with chronic kidney disease who are currently ESA users

Medicine or Vaccine (generic name)

daprodustat

Sponsor Identification Number

201754

Trial Registry Identification Number(#'s)

NCT02969655

Medical Condition

Anaemia

Phase

Phase 3

Link to study details on the GSK Clinical Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=201754

Link to study details on ClinicalTrials.gov (if available)

http://clinicaltrials.gov/show/NCT02969655

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=/

Datasets and Documents Available for this Study

Raw dataset	Annotated case report form	Dataset specifications	Protocol with any amendments
Analysis-ready dataset	Reporting and analysis plan	Clinical study report	Ready to Share

Additional information about the data and documents available for this study

This study is available in CDISC format.

Date Added to this Site

October 2020