A Clinical Study of KRN321 in Adult Subjects With Myelodysplastic Syndrome

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT01497145
First received: December 20, 2011
Last updated: May 15, 2014
Last verified: May 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01497145

Locations
Japan
Saitama, Japan
Korea, Republic of
Seoul, Korea, Republic of
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: May 15, 2014
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 August 25, 2014