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
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)
1 other identifier
observational
437
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2013
Typical duration for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 15, 2013
CompletedFirst Submitted
Initial submission to the registry
July 16, 2013
CompletedFirst Posted
Study publicly available on registry
July 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 4, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 4, 2016
CompletedResults Posted
Study results publicly available
August 7, 2018
CompletedAugust 9, 2019
August 1, 2019
3.1 years
July 16, 2013
October 23, 2017
August 7, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Hemoglobin Levels Within 10.0 - 12.0 g/dL at Months 8-10
g/dL = grams per deciliter
Months 8 to 10
Secondary Outcomes (3)
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
Percentage of Participants With MIRCERA Dose Adjustments
Up to 10 months
Number of Participants With Serious Adverse Events (AEs) and Non-Serious AEs
Up to 10 months
Study Arms (1)
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.
Eligibility Criteria
Participants with chronic kidney disease (CKD) not on dialysis with renal anemia (CKD Stages 3 \& 4) initiated on Mircera therapy
You may qualify if:
- 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
You may not qualify if:
- Malignant disease
- Significant or acute bleeding
- Poorly controlled hypertension
- Blood transfusion during the previous 2 months
- Hypersensitivity to Mircera or any of its excipients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Uni Hospital of Alexandroupoli; Nephrology Dept.
Alexandroupoli, 68100, Greece
Laiko General Hospital; Nephrology Div.
Athens, 115 27, Greece
Red Cross Hospital;Nephrology Dpt.
Athens, 11526, Greece
General Hospital Of Athens G.Gennimatas; Nephrology
Athens, 11527, Greece
Ippokrateion Gen. Hospital Of Athens; 2nd University Clinic Of Internal Medicine, Diabetes Center
Athens, 11527, Greece
Kyanos Stavros Private Hospital; Nephrologic Clinic
Athens, 11528, Greece
General Hospital Of West Attikis; Nephrology
Athens, 12351, Greece
University Hospital Attikon ; Pathology Clinic
Athens, 124 61, Greece
Nikea General Hospital; Nephrologic Clinic
Athens, 18454, Greece
General Hospital Of Dramas; Dialysis Center Unit
Drama, 66100, Greece
University Hospital Of Heraklion; Nefrologiki Clinic
Heraklion, 71110, Greece
Uni Hospital of Ioannina; Nephrology Dept.
Ioannina, 455 00, Greece
General Hospital Of Katerinis; Nephrology Unit
Katerini, Greece
General Hospital of Kilkis; Nephrology
Kilkis, 611 00, Greece
Univeristy Hospital of Larissa; Nephrology
Larissa, 41 110, Greece
Agios Andreas General Hospital; Nephrology
Pátrai, 26335, Greece
Olympion Therapeytirion; Nefrology
Pátrai, 26443, Greece
General Hospital Tzanio ; Nephrology
Piraeus, 18536, Greece
General Hospital Of Serres; Nephrology
Serres, 62100, Greece
AXEPA Pathology Section; A Pathology Clinic
Thessaloniki, 54636, Greece
Thermi Private Clinic; Nephrology
Thessaloniki, 570 01, Greece
Agios Loukas Private Clinic; Nephrology
Thessaloniki, Greece
Thessaliki Nossileytiki; Nephrology
Volos, 38221, Greece
General Hospital of Xanthi; Nephrology
Xánthi, Greece
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Study limitations include the absence of a control group and the observational design of the study. In addition, differences between subgroups found in non-interventional studies cannot be used to infer causality.
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2013
First Posted
July 18, 2013
Study Start
July 15, 2013
Primary Completion
September 4, 2016
Study Completion
September 4, 2016
Last Updated
August 9, 2019
Results First Posted
August 7, 2018
Record last verified: 2019-08