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

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uni Hospital of Alexandroupoli; Nephrology Dept., Alexandroupoli, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Time frame: Months 8 to 10

g/dL = grams per deciliter

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

Time frame: Months 8 to 10

g/dL = grams per deciliter
Percentage of Participants With MIRCERA Dose Adjustments

Time frame: Up to 10 months

Changes in Mircera dose since last visit are reported. The numbers of participants for which data were not reported are also indicated.
Number of Participants With Serious Adverse Events (AEs) and Non-Serious AEs

Time frame: Up to 10 months

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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Observational, Prospective Study to Evaluate the Hemoglobin Levels in Non-Dialysis Chronic Kidney Disease Subjects With Renal Anemia, Treated With MIRCERA (Methoxy-Polyethylene-Glycol-Epoetin Beta)

Acronym: OPTIMA

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Jul 18, 2013
Registry last updated: Aug 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed