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A clinical Phase 2 study of KRN321 in Adult Subjects with Myelodysplastic Syndrome

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

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221677
Enrollment
Unknown
Registered
2011-12-21
Start date
2011-12-21
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic Syndrome

Interventions

investigational material(s) Generic name etc : KRN321 INN of investigational material : Therapeutic category code : 249 Other hormone preparations (including antihormone preparations) Dosage and Admi

Sponsors

Kyowa Hakko Kirin Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
Efficacy: The proportion of subjects achieving a erythroid response Safety: Adverse events—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026