An Early Phase 2 Study of JTZ-951 in Anemic Patients with Chronic Kidney Disease Receiving Maintenance Hemodialysis <Anemia Correction study>
Phase 2
Completed
- Conditions
- Anemia with CKD
- Registration Number
- JPRN-jRCT2080222207
- Lead Sponsor
- Japan Tobacco Inc.
- Brief Summary
The efficacy and safety of JTZ-951 were demonstrated in anemic patients with CKD receiving maintenance hemodialysis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Patients receiving hemodialysis consistently 3 times weekly
-Pre-dialysis hemoglobin level of= > 9.0 g/dL and < 10.0 g/d
Exclusion Criteria
-Uncontrollable hypertension
-Congestive heart failure (NYHA classification III or higher)
-Excessive bleeding associated with surgical operation or blood transfusion within 12 weeks preceding the study
-IV iron replacement therapy within 4 weeks preceding the study
-Using anabolic androgenic steroid, testosterone enanthate or mepitiostan within 12 weeks preceding the study
-Severe infection, Systemic hematological disease, hemolytic anemia or hemorrhagic lesion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Hemoglobin level
- Secondary Outcome Measures
Name Time Method pharmacokinetics<br>safety<br>efficacy<br>-Reticulocyte count, hematocrit level, red blood cell count<br>-Subjective symptoms, objective findings, vital signs, 12-lead ECG, laboratory tests<br>-Plasma concentrations of JTZ-951