ate Phase 2 Study of JTZ-951 in Anemic Patients with Chronic Kidney Disease Receiving Maintenance Hemodialysis <Anemia Correction / Maintenance Study>
- Conditions
- Anemia with CKD
- Registration Number
- JPRN-jRCT2080222839
- Lead Sponsor
- Japan Tobacco Inc.
- Brief Summary
JTZ-951 had a dose-response relationship with Hb level increase rate. Hb level was maintained within the range of 10 to 12 g/dL when JTZ-951 was administered at doses adjusted based on Hb levels. JTZ-951 is confirmed to be safe when administered for a total of up to 30 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 71
*Patients receiving hemodialysis consistently 3 times weekly
*Hemoglobin level of = > 8.5 g/dL and < 10.0 g/d
*Uncontrollable hypertension
*Congestive heart failure (NYHA classification III or higher)
*Blood transfusion or excessive bleeding associated with surgical operation 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 safety<br>efficacy<br>pharmacokinetics<br>*Observed and change in Hb level<br>*Proportion of subjects maintaining an Hb level within the target range<br>*Subjective symptoms, objective findings, vital signs, 12-lead ECG, laboratory tests etc.<br>*Plasma concentrations of JTZ-951