- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01902628
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)
August 7, 2019 updated by: Hoffmann-La Roche
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)
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 Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
437
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alexandroupolis, Greece, 68100
- Uni Hospital of Alexandroupoli; Nephrology Dept.
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Athens, Greece, 11528
- Kyanos Stavros Private Hospital; Nephrologic Clinic
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Athens, Greece, 115 27
- Laiko General Hospital; Nephrology Div.
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Athens, Greece, 11526
- Red Cross Hospital;Nephrology Dpt.
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Athens, Greece, 11527
- General Hospital Of Athens G.Gennimatas; Nephrology
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Athens, Greece, 11527
- Ippokrateion Gen. Hospital Of Athens; 2nd University Clinic Of Internal Medicine, Diabetes Center
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Athens, Greece, 12351
- General Hospital Of West Attikis; Nephrology
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Athens, Greece, 124 61
- University Hospital Attikon ; Pathology Clinic
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Athens, Greece, 18454
- Nikea General Hospital; Nephrologic Clinic
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Drama, Greece, 66100
- General Hospital Of Dramas; Dialysis Center Unit
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Heraklion, Greece, 71110
- University Hospital Of Heraklion; Nefrologiki Clinic
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Ioannina, Greece, 455 00
- Uni Hospital of Ioannina; Nephrology Dept.
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Katerini, Greece
- General Hospital Of Katerinis; Nephrology Unit
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Kilkis, Greece, 611 00
- General Hospital of Kilkis; Nephrology
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Larissa, Greece, 41 110
- Univeristy Hospital of Larissa; Nephrology
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Patra, Greece, 26443
- Olympion Therapeytirion; Nefrology
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Patra, Greece, 26335
- Agios Andreas General Hospital; Nephrology
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Piraeus, Greece, 18536
- General Hospital Tzanio ; Nephrology
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Serres, Greece, 62100
- General Hospital Of Serres; Nephrology
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Thessaloniki, Greece, 54636
- AXEPA Pathology Section; A Pathology Clinic
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Thessaloniki, Greece, 570 01
- Thermi Private Clinic; Nephrology
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Thessaloniki, Greece
- Agios Loukas Private Clinic; Nephrology
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Volos, Greece, 38221
- Thessaliki Nossileytiki; Nephrology
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Xanthi, Greece
- General Hospital of Xanthi; Nephrology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Participants with chronic kidney disease (CKD) not on dialysis with renal anemia (CKD Stages 3 & 4) initiated on Mircera therapy
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Hemoglobin Levels Within 10.0 - 12.0 g/dL at Months 8-10
Time Frame: Months 8 to 10
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g/dL = grams per deciliter
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Months 8 to 10
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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g/dL = grams per deciliter
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Months 8 to 10
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Percentage of Participants With MIRCERA Dose Adjustments
Time Frame: Up to 10 months
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Changes in Mircera dose since last visit are reported.
The numbers of participants for which data were not reported are also indicated.
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Up to 10 months
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Number of Participants With Serious Adverse Events (AEs) and Non-Serious AEs
Time Frame: Up to 10 months
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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.
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Up to 10 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2013
Primary Completion (Actual)
September 4, 2016
Study Completion (Actual)
September 4, 2016
Study Registration Dates
First Submitted
July 16, 2013
First Submitted That Met QC Criteria
July 16, 2013
First Posted (Estimate)
July 18, 2013
Study Record Updates
Last Update Posted (Actual)
August 9, 2019
Last Update Submitted That Met QC Criteria
August 7, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ML28261
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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