Study of Erythropoietin (EPO) Administration Schedule | NCT01111630

Studies
Study of Erythropoietin (EPO) Administration Schedule

NCT01111630

Sponsor

JW Pharmaceutical

Status

Completed

Last Update Posted

May 14, 2014Estimated

Enrollment

60Estimated

Phase

Phase 4

Conditions

Chronic Renal Failure
Anaemia

Interventions

recomon (Epoetin Beta)
recomon (Epoetin Beta)

Countries

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

May 2014

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

Oct 2009

Primary Completion Date

Oct 2013Actual

Completion Date

Jan 2014Actual

First Submitted Date

Apr 25, 2010

First Submission Date that Met QC Criteria

Apr 26, 2010

First Posted Date

Apr 27, 2010Estimated

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

May 12, 2014

Last Update Posted Date

May 14, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this study is to compare the hemoglobin and hematocrit variability between once and three times weekly erythropoietin therapy for the anemia in patients with maintenance dialysis.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
once weekly	Experimental		Drug: recomon (Epoetin Beta)
three times weekly	Active Comparator		Drug: recomon (Epoetin Beta)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
recomon (Epoetin Beta)	Drug	administer once weekly	once weekly
recomon (Epoetin Beta)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The hemoglobin variability between once & three times weekly administration		24 weeks

Secondary Outcomes

Measure	Description	Time Frame
The hematocrit variability between once & three times weekly administration		24 weeks
Mean value of Hb and Hct between once & three times weekly administration		24 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged between 18 and 80.
Dialysis for at least 3 months.
Epoetin treatment for the last 3 months.
Baseline hemoglobin (Hb) value of >= 9.0 g/dL and < 13.0 g/dL.
Baseline mean weekly epoetin maintenance dose ≤ 12,000 IU
Patients who agree to participate in this study in writing.

Exclusion Criteria:

Hemoglobinopathies, i.e. sickle cell disease, thalassemia of all types.
Hemolysis as defined
Gastrointestinal bleeding necessitating treatment (medication, transfusion) within the last 3 months.
Patients with uncontrolled hypertension.
Acute infection of unstable systemic inflammatory disease.
Current malignant disease.
High likelihood of early withdrawal or interruption of the study (e.g. severe diseases within the last 3 months, such as myocardial infarction, unstable angina, stroke, deep venous thrombosis).
Life expectancy below 12 months.
Planned elective surgery during the study period.
Blood transfusions within the last 3 months.
Pregnancy and lactation.
Other conditions regarded as unsuitability by investigator.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
SugKyun Shin, Ph.D.	National Health Insurance Service Ilsan Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NHIC Ilsan Hospital		Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic
D000740	Anemia

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided