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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.

NCT04027517 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2021-03-22

No results posted yet for this study

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.

Conditions

  • Anemia of Chronic Kidney Disease

Interventions

DRUG

JTZ-951

Oral tablet * Dose adjustments as maintenance dose is allowed according to the result of Hb level.

DRUG

Darbepoetin Alfa

Intravenous administration * Dose adjustments as maintenance dose is allowed according to the result of Hb level.

Sponsors & Collaborators

Principal Investigators

  • Lee · JW Pharmaceutical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • South Korea

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04027517 on ClinicalTrials.gov