- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01497145
A Clinical Study of KRN321 in Adult Subjects With Myelodysplastic Syndrome
March 2, 2015 updated by: Kyowa Kirin Co., Ltd.
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
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
45
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Saitama, Japan
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Seoul, Korea, Republic of
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The proportion of subjects achieving a erythroid response
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Adverse Events as a Measure of Safety
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
December 20, 2011
First Submitted That Met QC Criteria
December 21, 2011
First Posted (Estimate)
December 22, 2011
Study Record Updates
Last Update Posted (Estimate)
March 4, 2015
Last Update Submitted That Met QC Criteria
March 2, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KRN321-401
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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