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

Kissei Pharmaceutical Co., Ltd.

Overview

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).

Study Type

INTERVENTIONAL

Masking

DOUBLE

Conditions

Anemia

Interventions

JR-131DRUG

Darbepoetin alfaDRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Multiple Locations, Japan

Outcomes

Primary Outcomes

Change from baseline in Hemoglobin level

Time frame: 24 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.