Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT01677767
Eligibility Criteria:
Inclusion Criteria:
* Adult patients, 18 to 65 years of age, inclusive
* Patients with chronic kidney disease on dialysis
* ESA naïve with Hb \< 10 g/dL, or on treatment with ESAs other than Mircera and Hb within the target range of 10-12 g/dL
* Adequate irons status as judged by the treating physician
Exclusion Criteria:
* Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
* Clinically significant concomitant disease or disorder as defined by protocol
* Clinical suspicion of pure red cell aplasia (PRCA)
* Planned elective surgery during the study period , except for cataract surgery or vascular access surgery
* Transfusion of red blood cells in the previous 2 months
* Pregnant women
* Contraindications for Mircera according to local prescribing information or as judged by the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01677767
Study Brief:
Protocol Section:
NCT01677767