Phase 3 Comparative Study of JTZ-951in Anemic Patients with Chronic Kidney Disease Receiving Maintenance Hemodialysis (SYMPHONY HD)
Phase 3
Completed
- Conditions
- Anemia with CKD
- Registration Number
- JPRN-jRCT2080223881
- Lead Sponsor
- Japan Tobacco Inc.
- Brief Summary
SYMPHONY HD demonstrted that JTZ-951 was as effective as DA in maintaining Hb levels in anemic patients with CKD receiving maintenance hemodialysis, and was generally well-tolerated over 24 weeks
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 173
Inclusion Criteria
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Difference in mean Hb level between arms during the evaluation period
- Secondary Outcome Measures
Name Time Method efficacy<br>pharmacogenomics<br>Observed Hb level at each Visit<br>Change in Hb level at each Visit