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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
  Purpose

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.


Condition Intervention Phase
MDS
 Drug: KRN321
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kyowa Hakko Kirin Company, Limited:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 45
Study Start Date: December 2011
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497145

Contacts
Contact: Project Management Department clinical.info@kyowa-kirin.co.jp

Locations
Japan
Recruiting
Saitama, Japan
Contact: Kyowa Hakko Kirin         clinical.info@kyowa-kirin.co.jp    
Korea, Republic of
Not yet recruiting
Seoul, Korea, Republic of
Contact: Kyowa Hakko Kirin         clinical.info@kyowa-kirin.co.jp    
Sponsors and Collaborators
Kyowa Hakko Kirin Company, Limited
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier: NCT01497145     History of Changes
Other Study ID Numbers: KRN321-401
Study First Received: December 20, 2011
Last Updated: August 23, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare
Korea: Food and Drug Administration

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
 Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013