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
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-07-18
Enrollment: 437
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Hemoglobin Levels Within 10.0 - 12.0 g/dL at Months 8-10
timeFrame: Months 8 to 10
Secondary outcomes:
measure: 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
timeFrame: Months 8 to 10
measure: Percentage of Participants With MIRCERA Dose Adjustments
timeFrame: Up to 10 months
measure: Number of Participants With Serious Adverse Events (AEs) and Non-Serious AEs
timeFrame: Up to 10 months
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: Uni Hospital of Alexandroupoli; Nephrology Dept.
city: Athens
country: Greece
facility: Laiko General Hospital; Nephrology Div.
city: Athens
country: Greece
facility: Red Cross Hospital;Nephrology Dpt.
city: Athens
country: Greece
facility: General Hospital Of Athens G.Gennimatas; Nephrology
city: Athens
country: Greece
facility: Ippokrateion Gen. Hospital Of Athens; 2nd University Clinic Of Internal Medicine, Diabetes Center
city: Athens
country: Greece
facility: Kyanos Stavros Private Hospital; Nephrologic Clinic
city: Athens
country: Greece
facility: General Hospital Of West Attikis; Nephrology
city: Athens
country: Greece
facility: University Hospital Attikon ; Pathology Clinic
city: Athens
country: Greece
facility: Nikea General Hospital; Nephrologic Clinic
city: Drama
country: Greece
facility: General Hospital Of Dramas; Dialysis Center Unit
city: Heraklion
country: Greece
facility: University Hospital Of Heraklion; Nefrologiki Clinic
city: Ioannina
country: Greece
facility: Uni Hospital of Ioannina; Nephrology Dept.
city: Katerini
country: Greece
facility: General Hospital Of Katerinis; Nephrology Unit
city: Kilkis
country: Greece
facility: General Hospital of Kilkis; Nephrology
city: Larissa
country: Greece
facility: Univeristy Hospital of Larissa; Nephrology
city: Patra
country: Greece
facility: Agios Andreas General Hospital; Nephrology
city: Patra
country: Greece
facility: Olympion Therapeytirion; Nefrology
city: Piraeus
country: Greece
facility: General Hospital Tzanio ; Nephrology
city: Serres
country: Greece
facility: General Hospital Of Serres; Nephrology
city: Thessaloniki
country: Greece
facility: AXEPA Pathology Section; A Pathology Clinic
city: Thessaloniki
country: Greece
facility: Thermi Private Clinic; Nephrology
city: Thessaloniki
country: Greece
facility: Agios Loukas Private Clinic; Nephrology
city: Volos
country: Greece
facility: Thessaliki Nossileytiki; Nephrology
city: Xanthi
country: Greece
facility: General Hospital of Xanthi; Nephrology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: