A Clinical Study of KRN321 in Adult Subjects With Myelodysplastic Syndrome

Phase 2

Completed

• Conditions: MDS

• Registration Number: NCT01497145
• Lead Sponsor: Kyowa Kirin Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-20
• Study First Submitted QC: 2011-12-21
• Study First Posted: 2011-12-22
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-02
• Last Update Posted: 2015-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The proportion of subjects achieving a erythroid response
Adverse Events as a Measure of Safety