OPTIMA: An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Participants With Chronic Kidney Disease Stages 3 and 4 Not on Dialysis
NCT ID: NCT01902628
Last Updated: 2019-08-09
Study Results
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View full resultsBasic Information
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COMPLETED
437 participants
OBSERVATIONAL
2013-07-15
2016-09-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Significant or acute bleeding
* Poorly controlled hypertension
* Blood transfusion during the previous 2 months
* Hypersensitivity to Mircera or any of its excipients
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Uni Hospital of Alexandroupoli; Nephrology Dept.
Alexandroupoli, , 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
University Hospital Of Heraklion; Nefrologiki Clinic
Heraklion, , Greece
Uni Hospital of Ioannina; Nephrology Dept.
Ioannina, , Greece
General Hospital Of Katerinis; Nephrology Unit
Katerini, , Greece
General Hospital of Kilkis; Nephrology
Kilkis, , Greece
Univeristy Hospital of Larissa; Nephrology
Larissa, , Greece
Agios Andreas General Hospital; Nephrology
Pátrai, , Greece
Olympion Therapeytirion; Nefrology
Pátrai, , Greece
General Hospital Tzanio ; Nephrology
Piraeus, , Greece
General Hospital Of Serres; Nephrology
Serres, , Greece
AXEPA Pathology Section; A Pathology Clinic
Thessaloniki, , Greece
Thermi Private Clinic; Nephrology
Thessaloniki, , Greece
Agios Loukas Private Clinic; Nephrology
Thessaloniki, , Greece
Thessaliki Nossileytiki; Nephrology
Volos, , Greece
General Hospital of Xanthi; Nephrology
Xánthi, , Greece
Countries
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Other Identifiers
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ML28261
Identifier Type: -
Identifier Source: org_study_id
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