Clareo Health | A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia
A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia
Saves the questions and what to expect into your notes, next to the visit they belong to.
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Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Written informed consent
Adult patients (≥ 18 years old) with chronic renal anemia
Maintenance erythropoietic therapy with methoxy polyethylene glycol-epoetin beta or a protocol-specified reference medication (epoetin alfa formulated with human albumin, epoetin beta or darbepoetin alfa) in one of the following studies: BA16528\[NCT00048048\], BA16285\[NCT00048035\], BA16286\[NCT00364832\], BA16736\[NCT00077597\], BA16738\[NCT00081471\], BA16739\[NCT00077610\], BA16740\[NCT00077623\], BA17283\[NCT00077766\] and BA17284\[NCT00081484\]
Hemoglobin (Hb) concentration between 10.5 and 13.0 g/dL
Adequate iron status defined as serum ferritin ≥ 100 ng/mL or Transferrin Saturation (TSAT)≥ 20% or percentage of hypochromic red blood cells (RBCs) \< 10%
You may not be if
Poorly controlled hypertension
History of epileptic seizure
Pure red cell aplasia
Chronic congestive heart failure \[New York Heart Association (NYHA) IV\]
High likelihood of early withdrawal or interruption of the study
Active malignant disease (except non-melanoma skin cancer)
