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 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT01892202
Eligibility Criteria:
Inclusion Criteria:
* Adult patients, 18 to 65 years of age inclusive
* Patients with chronic kidney disease Stage III-IV not on dialysis
* Hb \< 10 g/dL (for correction of anemia) or Hb 10-12 g/dL and receiving any other ESA (for maintenance of Hb levels)
* Adequate iron status as judged by the treating physician
Exclusion Criteria:
* Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
* Significant acute or chronic bleeding
* Hemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types)
* Active malignant disease during the last five years (except non-melanoma skin cancer)
* Uncontrolled or symptomatic secondary hyperparathyroidism
* Epileptic seizure during the last 6 months
* Poorly controlled hypertension (sitting blood pressure \> 170/100 mmHG)
* Myocardial infarction or stroke, or severe or unstable CAD
* Severe liver disease during the previous 6 months
* Congestive heart failure NYHA Class III-IV
* Diagnosis or suspicion of pure red cell aplasia (PRCA)
* Planned elective surgery during the study period (except cataract surgery and vascular access surgery)
* Transfusion of red blood cells during the previous 2 months
* Pregnant women
* Any contra-indications to Mircera
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01892202
Study Brief:
Protocol Section:
NCT01892202