A Study to Assess All-Cause Mortality and Cardiovascular Morbidity in Participants With Chronic Kidney Disease (CKD) on Dialysis and Those Not on Renal Replacement Therapy Receiving Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) or Reference Erythropoietin Stimulating Agents (ESAs)
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Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female participants with symptomatic anemia associated with CKD
Participants with renal anemia who are not treated with an ESA:
Anemia was defined as hemoglobin (Hb) concentration less than (\<) 11.0 grams per deciliter (g/dL) (mean of 2 screening values with at least one day and a maximum of 2 weeks between measurements) with clinical indication for ESA treatment
Participants with renal anemia who are on maintenance ESA therapy:
If on dialysis: regular long-term hemodialysis or peritoneal dialysis therapy with the same mode of dialysis for at least 3 months before screening
Hb concentration between 10 and 12 g/dL (mean of 2 screening values with at least one day and a maximum of 2 weeks between measurements)
Participants with adequate iron status defined as: serum ferritin above or equal to 100 micrograms per liter or transferrin saturation above or equal to 20 percent
You may not be if
Contraindications to ESA treatment: uncontrolled hypertension, hypersensitivity to the active substance or any of the excipients, any other contraindication to ESA therapy
Conditions known to cause inadequate response to ESA treatment or anemia other than symptomatic anemia associated with CKD:
History of hemoglobinopathy
Anemia due to hemolysis
Pure red cell aplasia
High likelihood of early withdrawal (for example, within 1 year) or interruption of the study
Pregnancy or breast-feeding
Women of childbearing potential without effective contraception
Administration of another investigational drug within 1 month before screening or planned during the study period
Clareo Health | A Study to Assess All-Cause Mortality and Cardiovascular Morbidity in Participants With Chronic Kidney Disease (CKD) on Dialysis and Those Not on Renal Replacement Therapy Receiving Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) or Reference Erythropoietin Stimulating Agents (ESAs)
