A Study of The Effect of Altitude on Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) Dose Requ… (NCT01519947) | Clinical Trial Compass
CompletedPhase 4
A Study of The Effect of Altitude on Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) Dose Requirements in Participants With Chronic Renal Anemia in Pre-Dialysis or Dialysis
Mexico87 participantsStarted 2012-05-30
Plain-language summary
This comparative, open-label, multicenter, parallel-group study evaluated the effect of altitude on the dose requirements of Mircera (methoxy polyethylene glycol-epoetin beta) to achieve a target hemoglobin concentration of 11-12 grams per deciliter (g/dL) in participants with chronic renal anemia in pre-dialysis and dialysis. Four groups of participants, at sea level (below 50 meters) or an altitude above 1800 meters, and pre-dialysis or dialysis, received 50-250 micrograms (mcg) Mircera subcutaneously (SC), according to the local prescribing label.
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 participants, \>/= 18 years of age
* Chronic kidney disease stage III-IV or V
* Probable start of dialysis within 18 months (pre-dialysis group)
* Hemodialysis or peritoneal dialysis in a stable regimen for at least 3 months (dialysis group)
* Adequate iron status
* Females of childbearing potential must agree to use two effective methods of contraception during the study and for at least 2 months following the last dose of study drug
Exclusion Criteria:
* Failing renal allograft in place
* Acute or chronic bleeding within 8 weeks prior to screening
* Transfusion of red blood cells within 8 weeks prior to screening
* Poorly controlled hypertension, defined as hypertension that needs hospitalization to obtain control
* History of seizures, hemoglobinopathies and/or severe liver disease
* Active malignant disease, except for non-melanoma skin cancer
* Immunosuppressive therapy in the 12 weeks prior to screening
* Treatment with any other investigational agent or participation in a clinical trial within 28 days prior to enrolment
* Known hypersensitivity to Mircera (methoxy polyethylene glycol-epoetin beta) or any of its excipients
* Pregnant or lactating women
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
Mean Dose Required to Achieve Target Hemoglobin of 11-12 g/dL