A Clinical Study of KRN321 in Adult Subjects With Myelodysplastic Syndrome

Kyowa Kirin Co., Ltd.45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

MDS

Interventions

KRN321DRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (2)

Unnamed facility

Saitama, Japan

Unnamed facility

Seoul, South Korea

Outcomes

Primary Outcomes

The proportion of subjects achieving a erythroid response

Adverse Events as a Measure of Safety

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.