A Phase III Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)

The purpose of this study is to investigate the equivalence of JR-131 to Darbepoetin alfa and evaluate the safety of JR-131 in renal anemia patients with chronic kidney disease (CKD).

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Multiple Locations, Japan

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients being treated with Darbepoetin alfa.

Exclusion criteria

Patients having complication or history of a cardiovascular / lung / brain infarction.
Patients having a pronounced hemorrhagic lesion.

Treatment and study plan

JR-131

Drug

darbepoetin alfa

Drug

Primary outcomes

Change from baseline in Hemoglobin level

Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Kissei Pharmaceutical Co., Ltd.

Industry

Collaborators

JCR Pharmaceuticals Co., Ltd.

Registry information

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Sep 23, 2016
Registry last updated: Apr 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed