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OPTIMA: An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Participants With Chronic Kidney Disease Stages 3 and 4 Not on Dialysis

NCT01902628

CompletedN/A

Sponsor: Hoffmann-La Roche

Conditions: Anemia

Countries: Greece

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. Participants initiated on treatment with Mircera according to the Summary of Product Characteristics and standard clinical practice were followed for 10 months.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* Malignant disease
* Significant or acute bleeding
* Poorly controlled hypertension
* Blood transfusion during the previous 2 months
* Hypersensitivity to Mircera or any of its excipients

Locations (24)

Alexandroupoli, Greece
Athens, Greece
Athens, Greece
Athens, Greece
Athens, Greece
Athens, Greece
Athens, Greece
Athens, Greece
Athens, Greece
Drama, Greece
Heraklion, Greece
Ioannina, Greece
Katerini, Greece
Kilkis, Greece
Larissa, Greece
Pátrai, Greece
Pátrai, Greece
Piraeus, Greece
Serres, Greece
Thessaloniki, Greece
Thessaloniki, Greece
Thessaloniki, Greece
Volos, Greece
Xánthi, Greece