Phase 3 study of subcutaneously-administered SK-1401 in patients with non-dialysis chronic kidney disease
Phase 3
Completed
- Conditions
- Renal anemia
- Registration Number
- JPRN-jRCT2080223471
- Lead Sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd.
- Brief Summary
In subjects with renal anemia associated with conservative chronic kidney disease treated with ESA, safety and efficacy were confirmed after the switched treatment from ESA to SK-1401 administered subcutaneously for 1 year.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 67
Inclusion Criteria
Patients with non-dialysis chronic kidney disease
- Patients treated with each of the following medicine: darbepoetin alfa, epoetin alfa, epoetin beta or epoetin beta pegol
- Patients with hemoglobin concentration between 10g/dL - 12.0g/dL (both inclusive)
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>Hemoglobin concentration
- Secondary Outcome Measures
Name Time Method safety<br>Incidence of adverse events or adverse reactions