Phase 3 Study of JTZ-951 in ESA-naive Anemic Patients with Chronic Kidney Disease Receiving Hemodialysis (SYMPHONY HD-naive)
Phase 3
Completed
- Conditions
- anemia with CKD
- Registration Number
- JPRN-jRCT2080223646
- Lead Sponsor
- Japan Tobacco Inc.
- Brief Summary
SYMPHONY HD-naive confirmed the effect of increases in Hb when JTZ-951 was administered at the initial dose of 4 mg once daily for 4 week. JTZ-951 was confirmed to be safe when administered for a total of up to 24 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
* ESA naive patients
* Hemoglobin level of => 8.0 g/dL and < 10.0 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>Hb level increase rate per week
- Secondary Outcome Measures
Name Time Method efficacy<br>Observed Hb level at each Visit<br>Change in Hb level at each Visit