A clinical study of KRN321 in pediatric patients
Phase 3
- Conditions
- Renal anemia
- Registration Number
- JPRN-jRCT2080221341
- Lead Sponsor
- Kyowa Hakko Kirin Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Written informed consent from guardian
- ND patients (diagnosed with CKD and not receiving hemodialysis), PD patients (receiving peritoneal dialysis), or HD patients (receiving hemodialysis once a week or over)
Exclusion Criteria
- Uncontrolled hypertension
- Congestive heart failure
- Malignant tumor, hematological disease or hemorrhagic lesion
- Within 16 weeks preceding the study, excessive bleeding or blood transfusion associated with surgical operation etc.
- Serious allergy (include drug hypersensitivity)
- Hypersensitivity for rHuEPO agents
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy (Hb level)<br><br>Safety (Adverse events)
- Secondary Outcome Measures
Name Time Method