Status:
COMPLETED
OPTIMA: An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Participants With Chronic Kidney Disease Stages 3 and 4 Not on Dialysis
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Brief Summary
This prospective observational study evaluated the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease participants on dialysis with renal anemia. Parti...
Eligibility Criteria
Inclusion
- Adult participants, \>/= 18 years of age
- Participants with chronic kidney disease (CKD) not on dialysis with renal anemia (CKD Stages 3 \& 4)
- Initiated on Mircera treatment (participants may have received Mircera treatment for up to 3 months before study enrollment)
- Life expectancy \> 10 months
Exclusion
- Malignant disease
- Significant or acute bleeding
- Poorly controlled hypertension
- Blood transfusion during the previous 2 months
- Hypersensitivity to Mircera or any of its excipients
Key Trial Info
Start Date :
July 15 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 4 2016
Estimated Enrollment :
437 Patients enrolled
Trial Details
Trial ID
NCT01902628
Start Date
July 15 2013
End Date
September 4 2016
Last Update
August 9 2019
Active Locations (24)
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1
Uni Hospital of Alexandroupoli; Nephrology Dept.
Alexandroupoli, Greece, 68100
2
Laiko General Hospital; Nephrology Div.
Athens, Greece, 115 27
3
Red Cross Hospital;Nephrology Dpt.
Athens, Greece, 11526
4
General Hospital Of Athens G.Gennimatas; Nephrology
Athens, Greece, 11527