Study of Erythropoietin (EPO) Administration Schedule (NCT01111630) | Clinical Trial Compass
CompletedPhase 4
Study of Erythropoietin (EPO) Administration Schedule
South Korea60 participantsStarted 2009-10
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The hemoglobin variability between once & three times weekly administration