JPRN-jRCT2080223814CompletedPhase 3
Phase 3 Study to Compare the Efficacy and Safety of JTZ-951 with Darbepoetin Alfa in Anemic Patients with Chronic Kidney Disease Not Requiring Dialysis <Anemia Correction / Switch / Maintenance Study> (SYMPHONY ND)
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Japan Tobacco Inc.
- Enrollment
- 216
Study Overview
Brief Summary
SYMPHONY ND demonstrated that JTZ-951 was as effective as DA in maintaining Hb levels in anemic patients with CKD not requiring dialysis, and was generally well-tolerated over 24 weeks.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •ESA naive patients:
- •Hemoglobin level of => 8.0 g/dL and =< 10.5 g/dL
- •ESA treated patients:
- •Hemoglobin level of => 9.5 g/dL and =< 12.0 g/d
Exclusion Criteria
- •Patients with poorly controlled hypertension
- •Patients with congestive heart failure or unstable angina
- •Patients with malignancy
Investigators
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