A clinical Phase 2 study of KRN321 in Adult Subjects with Myelodysplastic Syndrome
Phase 2
- Conditions
- Myelodysplastic Syndrome
- Registration Number
- JPRN-jRCT2080221677
- 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
IPSS low- or intermediate-1-risk MDS diagnosed at enrollment
-Serum EPO concentration 500 mIU/mL
-Hemoglobin concentration 9.0 g/dL at the screening examinations
Exclusion Criteria
-Previous bone marrow or hematopoietic stem cell transplantation
-History of pure red cell aplasia
-Cardiac conditions including angina pectoris, congestive heart failure, uncontrolled arrhythmia and hypertension
-Those who have increased risk of thrombosis during the study
-Uncontrolled diabetes mellitus
-Concurrent active infection or chronic inflammatory disease
-Other causes of anemia
-Previous or concurrent active malignancies other than MDS
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy: The proportion of subjects achieving a erythroid response<br>Safety: Adverse events
- Secondary Outcome Measures
Name Time Method