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A Clinical Study of KRN321 in Adult Subjects With Myelodysplastic Syndrome

This study is currently recruiting participants.
Verified August 2012 by Kyowa Hakko Kirin Company, Limited
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT01497145
First received: December 20, 2011
Last updated: August 23, 2012
Last verified: August 2012
History of Changes

December 20, 2011
August 23, 2012
December 2011
Not Provided
  • The proportion of subjects achieving a erythroid response [ Designated as safety issue: No ]
  • Adverse Events as a Measure of Safety [ Designated as safety issue: Yes ]
  • Safety [ Designated as safety issue: Yes ]
    Adverse events
  • Efficacy [ Designated as safety issue: No ]
    The proportion of subjects achieving an erythroid response
Complete list of historical versions of study NCT01497145 on ClinicalTrials.gov Archive Site
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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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
MDS
Drug: KRN321
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
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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
Both
20 Years and older
No
Contact: Project Management Department clinical.info@kyowa-kirin.co.jp
Japan,   Korea, Republic of
 
NCT01497145
KRN321-401
No
Kyowa Hakko Kirin Company, Limited
Kyowa Hakko Kirin Company, Limited
Not Provided
Not Provided
Kyowa Hakko Kirin Company, Limited
August 2012

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