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Completed

NCT Number: NCT01497145

A Clinical Study of KRN321 in Adult Subjects With 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.

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Key information

Conditions

MDS

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Saitama, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KRN321

Drug

Primary outcomes

  1. The proportion of subjects achieving a erythroid response

  2. Adverse Events as a Measure of Safety

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 22, 2011
Registry last updated
Mar 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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