Phase 3 Comparative Study of JTZ-951 in Anemic Patients with Chronic Kidney Disease Not Requiring Dialysis (SYMPHONY ND)
Phase 3
Completed
- Conditions
- Anemia with CKD
- Registration Number
- JPRN-jRCT2080223814
- Lead Sponsor
- Japan Tobacco Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 216
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
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>Observed Hb level at each Visit<br>Change in Hb level at each Visit