OPTIMA: An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Participants With Chronic Kidney Disease Stages 3 and 4 Not on Dialysis
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 437
- 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
- 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)
Laiko General Hospital; Nephrology Div.
🇬🇷Athens, Greece
General Hospital Of Athens G.Gennimatas; Nephrology
🇬🇷Athens, Greece
Uni Hospital of Alexandroupoli; Nephrology Dept.
🇬🇷Alexandroupolis, Greece
Red Cross Hospital;Nephrology Dpt.
🇬🇷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
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
Univeristy Hospital of Larissa; Nephrology
🇬🇷Larissa, Greece
General Hospital Of Katerinis; Nephrology Unit
🇬🇷Katerini, Greece
General Hospital of Kilkis; Nephrology
🇬🇷Kilkis, Greece
Agios Andreas General Hospital; Nephrology
🇬🇷Patra, Greece
Olympion Therapeytirion; Nefrology
🇬🇷Patra, Greece
General Hospital Tzanio ; Nephrology
🇬🇷Piraeus, Greece
General Hospital Of Serres; Nephrology
🇬🇷Serres, Greece
Thermi Private Clinic; Nephrology
🇬🇷Thessaloniki, Greece
AXEPA Pathology Section; A Pathology Clinic
🇬🇷Thessaloniki, Greece
Agios Loukas Private Clinic; Nephrology
🇬🇷Thessaloniki, Greece
Thessaliki Nossileytiki; Nephrology
🇬🇷Volos, Greece
General Hospital of Xanthi; Nephrology
🇬🇷Xanthi, Greece
General Hospital Of West Attikis; Nephrology
🇬🇷Athens, Greece