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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02912494

Enrollment

Unknown

Registered

2016-09-23

Start date

2016-09-30

Completion date

2017-09-30

Last updated

2019-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

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).

Interventions

DRUGJR-131

DRUGDarbepoetin alfa

Study design

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Change from baseline in Hemoglobin level	24 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026