A Clinical Study of KRN321 in Adult Subjects With Myelody... | NCT01497145

Studies
A Clinical Study of KRN321 in Adult Subjects With Myelodysplastic Syndrome

NCT01497145

Sponsor

Kyowa Kirin Co., Ltd.

Status

Completed

Last Update Posted

Mar 4, 2015Estimated

Enrollment

45Estimated

Phase

Phase 2

Conditions

Interventions

KRN321

Countries

Japan
South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Feb 2014Actual

Completion Date

Feb 2014Actual

First Submitted Date

Dec 20, 2011

First Submission Date that Met QC Criteria

Dec 21, 2011

First Posted Date

Dec 22, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2015

Last Update Posted Date

Mar 4, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Name	Type	Description	Arm Group Labels	Other Names
KRN321	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The proportion of subjects achieving a erythroid response
Adverse Events as a Measure of Safety

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068256	Darbepoetin alfa

Ancestor Terms

ID	Term
D004921	Erythropoietin
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Saitama			Japan