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

N/ACompletedNCT01902628

Hoffmann-La Roche437 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

437

Conditions

Anemia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Uni Hospital of Alexandroupoli; Nephrology Dept.

Alexandroupoli, Greece

Outcomes

Primary Outcomes

Percentage of Participants With Hemoglobin Levels Within 10.0 - 12.0 g/dL at Months 8-10

g/dL = grams per deciliter

Time frame: Months 8 to 10

Secondary Outcomes

Percentage of Participants With Hemoglobin Levels Within the Following Ranges: 11.0 - 12.0 g/dL, 11.0 - 13.0 g/dL, and 10.0 - 13.0 g/dL at Months 8-10

g/dL = grams per deciliter

Time frame: Months 8 to 10

Percentage of Participants With MIRCERA Dose Adjustments

Changes in Mircera dose since last visit are reported. The numbers of participants for which data were not reported are also indicated.

Time frame: Up to 10 months

Number of Participants With Serious Adverse Events (AEs) and Non-Serious AEs

An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. A serious AE is any experience that suggests a significant hazard, contraindication, side effect, or precaution.

Time frame: Up to 10 months

Data from ClinicalTrials.gov

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