ate Phase 2 Study of JTZ-951 in Anemic Patients with Chronic Kidney Disease Not Requiring Dialysis <Anemia Correction / Switch / Maintenance Study>
- Conditions
- Anemia with CKD
- Registration Number
- JPRN-jRCT2080222829
- Lead Sponsor
- Japan Tobacco Inc.
- Brief Summary
JTZ-951 had a dose-response relationship with Hb increase rate. The proportion of subjects who maintained an Hb within the range of the baseline +-1.0 g/dL at endpoint tended to be higher in the JTZ-951 2 and 4 mg arms than in the placebo arm, although there were no significant differences. The Hb at EOT was increased with dose. Hb was maintained within the range of 10 to 12 g/dL when administered at doses adjusted based on Hb. JTZ-951 is confirmed to be safe when administered for up to 30 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 201
* Patients with chronic kidney disease not requiring dialysis
* Group 1 (ESA-naive): Hemoglobin level of = > 8.0 and = < 10.5 g/dL
* Group 2 (ESA-treated): Hemoglobin level of = > 9.5 and = < 12.0 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 mepitiostane 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