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A Clinical 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
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01497145
Enrollment
45
Registered
2011-12-22
Start date
2011-12-31
Completion date
2014-02-28
Last updated
2015-03-04

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

Conditions

MDS

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.

Interventions

DRUGKRN321

Sponsors

Kyowa Kirin Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The proportion of subjects achieving a erythroid response—
Adverse Events as a Measure of Safety—

Countries

Japan, South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026