Phase 3 Study to Compare the Efficacy and Safety of JTZ-951 with Darbepoetin Alfa in Anemic Patients with Chronic Kidney Disease Not Requiring Dialysis (Anemia Correction / Switch / Maintenance Study).
Status: Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 29 Nov 2019
Price : $35 *
At a glance
- Drugs Enarodustat (Primary) ; Darbepoetin alfa
- Indications Anaemia
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms Anemia Correction / Switch / Maintenance Study
- Sponsors Japan Tobacco
- 29 Nov 2019 According to a Japan Tobacco media release, Japan Tobacco filed a New Drug Application for JTZ-951, for anemia associated with chronic kidney disease (CKD).
- 12 Jul 2019 Marketing application for JTZ-951 in Japan will be submitted based on the results of this and other clinical studies.
- 12 Jul 2019 According to a Japan Tobacco media release, Primary endpoint (Differences in mean hemoglobin at week 20, 22 and 24 ( non-inferiority criterion)) has been met.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History