A Clinical Study of KRN321 in Adult Subjects With Myelodysplastic Syndrome

Kyowa Kirin

Status and phase: Completed; Phase 2

Conditions: MDS

Treatments: Drug: KRN321

Study type: Interventional

Funder types: Industry

Identifiers

NCT01497145

KRN321-401

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)