A Non-Interventional Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease Not on Dialysis
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ClinicalTrials.gov Identifier: NCT01892202
Expanded Access Status :
No longer available
(Investigators lost interest in conducting the trail due to unexplained reasons)
This multicenter observational study will evaluate the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease not on dialysis in routine clinical practice. Eligible patients treated with Mircera for chronic renal anemia according to the standard of care and in line with the current local label will be followed for 6 months.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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