OPTIMA: An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Participants With Chronic Kidney Disease Stages 3 and 4 Not on Dialysis (OPTIMA)
|ClinicalTrials.gov Identifier: NCT01902628|
Recruitment Status : Completed
First Posted : July 18, 2013
Results First Posted : August 7, 2018
Last Update Posted : August 9, 2019
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||437 participants|
|Official 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)|
|Actual Study Start Date :||July 15, 2013|
|Actual Primary Completion Date :||September 4, 2016|
|Actual Study Completion Date :||September 4, 2016|
Participants with CKD
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.
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902628
|Study Director:||Clinical Trials||Hoffmann-La Roche|