NCT01497145
Completed
Phase 2
A Phase 2, Randomized, Open-Label, Parallel, Comparative, Dose-Response Study to Evaluate the Efficacy and Safety of KRN321 in Adult Subjects With Low- or Intermediate-1-Risk Myelodysplastic Syndrome
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- MDS
- Sponsor
- Kyowa Kirin Co., Ltd.
- Enrollment
- 45
- Primary Endpoint
- The proportion of subjects achieving a erythroid response
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
The proportion of subjects achieving a erythroid response
Adverse Events as a Measure of Safety
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