Back to resultsStudy of Erythropoietin (EPO) Administration Schedule
Primary Purpose
Chronic Renal Failure, Anaemia
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
recomon (Epoetin Beta)
recomon (Epoetin Beta)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Renal Failure focused on measuring chronic renal failure, Anaemia
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.
Sites / Locations
- NHIC Ilsan Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
once weekly
three times weekly
Arm Description
Outcomes
Primary Outcome Measures
The hemoglobin variability between once & three times weekly administration
Secondary Outcome Measures
The hematocrit variability between once & three times weekly administration
Mean value of Hb and Hct between once & three times weekly administration
Drop out rate during dose fix period
Mean value of Hb and Hct during dose fix period
Variability of Hb and Hct during dose fix period
Weekly oetin-beta maintenance dose between once & three times weekly administration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01111630
Brief Title
Study of Erythropoietin (EPO) Administration Schedule
Official Title
Compare the Hemoglobin and Hematocrit Variability Between Once & Three Times Weekly Erythropoietin Therapy for the Anemia in Patients With Maintenance Dialysis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JW Pharmaceutical
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure, Anaemia
Keywords
chronic renal failure, Anaemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
once weekly
Arm Type
Experimental
Arm Title
three times weekly
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
recomon (Epoetin Beta)
Intervention Description
administer once weekly
Intervention Type
Drug
Intervention Name(s)
recomon (Epoetin Beta)
Intervention Description
administer three times weekly
Primary Outcome Measure Information:
Title
The hemoglobin variability between once & three times weekly administration
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
The hematocrit variability between once & three times weekly administration
Time Frame
24 weeks
Title
Mean value of Hb and Hct between once & three times weekly administration
Time Frame
24 weeks
Title
Drop out rate during dose fix period
Time Frame
24 weeks
Title
Mean value of Hb and Hct during dose fix period
Time Frame
24 weeks
Title
Variability of Hb and Hct during dose fix period
Time Frame
24weeks
Title
Weekly oetin-beta maintenance dose between once & three times weekly administration
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SugKyun Shin, Ph.D.
Organizational Affiliation
National Health Insurance Service Ilsan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
NHIC Ilsan Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
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Study of Erythropoietin (EPO) Administration Schedule
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