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A Clinical Study of KRN321 in Adult Subjects With Myelodysplastic Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01497145
First Posted: December 22, 2011
Last Update Posted: March 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd
December 20, 2011
December 22, 2011
March 4, 2015
December 2011
February 2014   (Final data collection date for primary outcome measure)
  • The proportion of subjects achieving a erythroid response
  • Adverse Events as a Measure of Safety
  • Efficacy
    The proportion of subjects achieving an erythroid response
  • Safety
    Adverse events
Complete list of historical versions of study NCT01497145 on ClinicalTrials.gov Archive Site
Not Provided
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A Clinical Study of KRN321 in Adult Subjects With Myelodysplastic Syndrome
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
MDS
Drug: KRN321
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
February 2014
February 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan,   Korea, Republic of
 
 
NCT01497145
KRN321-401
No
Not Provided
Not Provided
Kyowa Hakko Kirin Co., Ltd
Kyowa Hakko Kirin Co., Ltd
Not Provided
Not Provided
Kyowa Hakko Kirin Co., Ltd
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP