A Clinical Study of KRN321 in Adult Subjects With Myelodysplastic Syndrome

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Hakko Kirin Company, Limited; Kyowa Kirin Co., Ltd.
• Treatments: Darbepoetin alfa

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