A Clinical Study of KRN321 in Adult Subjects With Myelodysplastic Syndrome

MDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01497145
• Other study ID #: KRN321-401
• Status: Completed
• Phase: Phase 2
• First received: December 20, 2011
• Last updated: March 2, 2015
• Start date: December 2011
• Est. completion date: February 2014

Study information

• Verified date: March 2015
• Source: Kyowa Hakko Kirin Company, Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareKorea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• MDS
• Myelodysplastic Syndromes
• Preleukemia

Intervention

Drug:
• KRN321

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Company, Limited

Countries where clinical trial is conducted

Japan,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of subjects achieving a erythroid response			No
Primary	Adverse Events as a Measure of Safety			Yes