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

Roche

Status: Completed

Conditions: Anemia

Study type: Observational

Funder types: Industry

Identifiers

NCT01902628

ML28261

Details and patient eligibility

About

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.

Enrollment: 437 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

437 participants in 1 patient group

Participants with CKD

Description:

This single cohort included participants with CKD not receiving dialysis (Stages 3 and 4), with renal anemia, treated with MIRCERA according to usual clinical practice.