A Study of Epoetin Beta (NeoRecormon) in Predialysis Patients With Renal Anemia (NCT02569515) | Clinical Trial Compass
CompletedPhase 4
A Study of Epoetin Beta (NeoRecormon) in Predialysis Patients With Renal Anemia
Bulgaria58 participantsStarted 2004-10
Plain-language summary
This study will evaluate the tolerability, and effect on quality of life, in patients receiving multi-dose NeoRecormon administered by RecoPen in predialysis patients with chronic renal anemia. The anticipated time on study treatment is 10 months, and the target sample size is 60 individuals.
Who can participate
Age range
18 Years – 65 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:
* Adult patients 18-65 years of age
* Chronic renal failure (Stages I-III)
* No previous epoetin therapy
Exclusion Criteria:
* Poorly controlled hypertension
* History or evidence of malignancy
* Relevant acute or chronic bleeding (requiring therapy) within 3 months before study drug
* Women who are pregnant or breastfeeding
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
Percentage of participantss who change to once weekly NeoRocormon
Timeframe: 10 months
2
Percentage of participants with local intolerabilities (pain/allergic reactions)
Timeframe: 10 months
3
Percentage of participants who withdrew due to inability to use RecoPen
Timeframe: 10 months
4
Percentage of participants who changed dose during treatmnent