Back to resultsA Clinical Study of KRN321 in Adult Subjects With Myelodysplastic Syndrome
Primary Purpose
MDS
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
KRN321
Sponsored by
About this trial
This is an interventional treatment trial for MDS
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
Sites / Locations
Outcomes
Primary Outcome Measures
The proportion of subjects achieving a erythroid response
Adverse Events as a Measure of Safety
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01497145
Brief Title
A Clinical Study of KRN321 in Adult Subjects With Myelodysplastic Syndrome
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MDS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
KRN321
Primary Outcome Measure Information:
Title
The proportion of subjects achieving a erythroid response
Title
Adverse Events as a Measure of Safety
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Facility Information:
City
Saitama
Country
Japan
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study of KRN321 in Adult Subjects With Myelodysplastic Syndrome
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