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

Anemia of Chronic Kidney Disease Clinical Trial

Official title:
A Multi-center, Randomized, Open-label, Active-controlled, Parallel-group, Phase III Study to Compare the Efficacy and Safety of JTZ-951 With Darbepoetin Alfa in Anemic Patients With Chronic Kidney Disease Receiving Maintenance Hemodialysis.

Clinical Trial 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.

Clinical Trial Description

The primary objective is to demonstrate non-inferiority of JTZ-951 to darbepoetin alfa. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04027517
Study type Interventional
Source JW Pharmaceutical
Contact
Status Completed
Phase Phase 3
Start date January 15, 2019
Completion date February 23, 2021
View Details
See also
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