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

Phase 3

Completed

• Conditions: Anemia
• Interventions: Drug: JR-131; Drug: Darbepoetin alfa

• Registration Number: NCT02912494
• Lead Sponsor: Kissei Pharmaceutical Co., Ltd.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-21
• Study First Submitted QC: 2016-09-21
• Study First Posted: 2016-09-23
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-29
• Last Update Posted: 2019-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
JR-131	JR-131	-
Darbepoetin alfa	Darbepoetin alfa	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in Hemoglobin level	24 weeks