A Clinical Study of KRN321 in Adult Subjects With Myelodysplastic Syndrome
Phase 2
Completed
- Conditions
- MDS
- Registration Number
- NCT01497145
- Lead Sponsor
- Kyowa Kirin Co., Ltd.
- Brief Summary
This is a multicenter, Randomized, Open-Label, Parallel, Comparative, Dose-Response Study to Evaluate the Efficacy and Safety study of KRN321 of subcutaneous injection in Adult Subjects with Low- or Intermediate-1-Risk Myelodysplastic Syndrome.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
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
- PARALLEL
- Primary Outcome Measures
Name Time Method The proportion of subjects achieving a erythroid response Adverse Events as a Measure of Safety
- Secondary Outcome Measures
Name Time Method