Phase 3 study of intravenously-administered SK-1403 in patients undergoing hemodialysis associated with renal anemia
Phase 3
Completed
- Conditions
- Renal anemia
- Registration Number
- JPRN-jRCT2080223470
- Lead Sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd.
- Brief Summary
The clinical equivalence of SK-1401 and darbepoetin alfa was confirmed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 167
Inclusion Criteria
Patients undergoing hemodialysis
- Patients treated with darbepoetin alfa once a week
- Patients meet both of the following conditions: Hemoglobin concentrations during the screening period are between 9.5g/dL - 12.5g/dL and mean hemoglobin concentration is between 10g/dL - 12.0g/dL.
Exclusion Criteria
- Patients with history of massive bleeding or erythrocyte transfusion
- Patients with apparent hemorrhagic lesion
- Patients with malignant tumor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Change in mean hemoglobin concentration at 21w-24w from the baseline
- Secondary Outcome Measures
Name Time Method safety<br>Incidence of adverse events or adverse reactions