drugset / Trial / NCT04027517

A Study to Evaluate Efficacy and Safety of JTZ-951 Compared to Darbepoetin Alfa in Korean Renal Anemia Patients Receiving Hemodialysis.

NCT04027517

Phase 3 Completed 172 enrolled JW Pharmaceutical
RandomizedParallel-groupOpen-labelTreatment

Summary

JTZ-951 is a currently being developed as a treatment for renal anemia. This study aims to evaluate the efficacy and safety of JTZ-951 following a switch from erythropoiesis-stimulating agent (ESA) in Korean subjects receiving HemoDialysis with renal anemia. This study is a Phase III, open, active-controlled, parallel-group, multi-center study. The total duration of the study will be 30 weeks including screening, treatment and follow-up.

Timeline

Start
2019-01-15
Primary completion
2021-02-23
Completion
2021-02-23

Drugs

EvaluationDrugModalityDoseRoute
Comparator Darbepoetin alfa Protein / enzyme biologic Intravenous
Subject Enarodustat Small molecule Oral