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

Completed

• Conditions: Anemia

• Registration Number: NCT01902628
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-15
• Study First Submitted: 2013-07-16
• Study First Submitted QC: 2013-07-16
• Study First Posted: 2013-07-18
• Primary Completion: 2016-09-04
• Study Completion: 2016-09-04
• Results First Submitted: 2017-10-23
• Results First Submitted QC: 2018-07-31
• Results First Posted: 2018-08-07
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-07
• Last Update Posted: 2019-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 437

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Hemoglobin Levels Within 10.0 - 12.0 g/dL at Months 8-10	Months 8 to 10	g/dL = grams per deciliter

Secondary Outcome Measures

Name	Time	Method
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	Months 8 to 10	g/dL = grams per deciliter
Percentage of Participants With MIRCERA Dose Adjustments	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	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.

Trial Locations

Locations (24)

Uni Hospital of Alexandroupoli; Nephrology Dept.; 🇬🇷 Alexandroupolis, Greece

Laiko General Hospital; Nephrology Div.; 🇬🇷 Athens, Greece

Red Cross Hospital;Nephrology Dpt.; 🇬🇷 Athens, Greece

General Hospital Of Athens G.Gennimatas; Nephrology; 🇬🇷 Athens, Greece

Ippokrateion Gen. Hospital Of Athens; 2nd University Clinic Of Internal Medicine, Diabetes Center; 🇬🇷 Athens, Greece

Kyanos Stavros Private Hospital; Nephrologic Clinic; 🇬🇷 Athens, Greece

General Hospital Of West Attikis; Nephrology; 🇬🇷 Athens, Greece

University Hospital Attikon ; Pathology Clinic; 🇬🇷 Athens, Greece

Nikea General Hospital; Nephrologic Clinic; 🇬🇷 Athens, Greece

General Hospital Of Dramas; Dialysis Center Unit; 🇬🇷 Drama, Greece

Scroll for more (14 remaining)