Status:
COMPLETED
A Clinical Study of KRN321 in Adult Subjects With Myelodysplastic Syndrome
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
MDS
Eligibility:
All Genders
20+ years
Phase:
PHASE2
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 I...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2014
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01497145
Start Date
December 1 2011
End Date
February 1 2014
Last Update
March 4 2015
Active Locations (2)
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1
Saitama, Japan
2
Seoul, South Korea