A Phase III Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)
- 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
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
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What is the molecular mechanism of action of JR-131 in treating renal anemia compared to Darbepoetin alfa?
How does JR-131's efficacy in CKD-related anemia compare to standard erythropoiesis-stimulating agents like Darbepoetin alfa?
Which biomarkers are associated with response prediction for erythropoietin receptor agonists in CKD anemia patients?
What are the potential adverse events and management strategies for JR-131 in chronic kidney disease populations?
How do erythropoiesis-stimulating agents like JR-131 and Darbepoetin alfa compare to other anemia treatments in CKD patients?