A Study of Mircera (C.E.R.A.) in Patients With Pre-Dialysis Chronic Renal Anemia (NCT01342640) | Clinical Trial Compass
CompletedPhase 4
A Study of Mircera (C.E.R.A.) in Patients With Pre-Dialysis Chronic Renal Anemia
Egypt70 participantsStarted 2011-07-18
Plain-language summary
This single arm, open label, multicenter study will evaluate the safety and change in hemoglobin levels of Mircera (C.E.R.A.; methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia who are not on dialysis. Patients will receive as a recommended starting dose 1.2 micrograms of Mircera subcutaneously every 4 weeks. The starting dose is dependent on the patient's weight. Dose adjustment may be required due to inadequate or excessive treatment response. The anticipated time on study treatment is 28 weeks.
Who can participate
Age range
18 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, age \>/=18 years
* Diagnosis of chronic renal anemia
* Not on dialysis
* Hemoglobin concentration \<10 g/dl
* No erythropoiesis stimulating agent (ESA) therapy during the 3 months before study start
* Estimated glomerular filtration rate (EGFR) \<60 ml/min and \>/=20 ml/min
* Adequate iron status
Exclusion Criteria:
* Transfusion of red blood cells during the previous 2 months
* Poorly controlled hypertension
* Significant acute or chronic bleeding, e.g. gastrointestinal bleeding
* Active malignant disease (except non-melanoma skin cancer)
* Hemolysis
* Hemoglobinopathies, e.g. sickle-cell disease, thalassemia
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
Change From Baseline in Mean Hb Concentration at Week 20
Timeframe: Baseline (Week 0), Week 20
2
Change From Baseline in Mean Hb Concentration at Week 24
Timeframe: Baseline (Week 0), Week 24
3
Change From Baseline in Mean Hb Concentration at Week 28