Clinical trial NCT01051323: An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Renal Anemia
Official title: Non-interventional Study to Investigate Hemoglobin Levels and Dose Over Time in the Daily Use of Mircera for Renal Anemia in Larger Centers, and to Detect Differences Between Standard of Care in the Centers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-01-18
Enrollment: 1580
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: CKD patients treated with Mirecera at different medical centers

Brief summary: This observational study will investigate hemoglobin levels and Mircera (methoxy polyethyleneglycol-epoetin beta) dose over time in patients with chronic kidney disease, and compare standards of care between centers. Data from each patient will be collected over 12 months of Mircera therapy.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>/= 18 years of age
* chronic kidney disease
* informed consent for data transmission

Exclusion Criteria:

* serious hematological or infectious disease
* acute bleeding in the 16 weeks preceding data collection
* participation in an interventional trial
* female patients: pregnancy or breast-feeding

Primary outcomes:
measure: Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range
timeFrame: Month 0 to Month 12
measure: Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size
timeFrame: Month 0 to Month 12
measure: Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size
timeFrame: Month 6 to Month 12
measure: Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size
timeFrame: Month 0 to Month 12
measure: Serum Ferritin Values
timeFrame: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
measure: Serum Iron Values
timeFrame: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
measure: Transferrin Values
timeFrame: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
measure: Transferrin Saturation Values
timeFrame: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
measure: C-reactive Protein (CRP) Values
timeFrame: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
measure: Number of Physicians Satisfied With Treatment at Final Visit
timeFrame: Month 12 or early discontinuation
measure: Number of Participants Who Continued Treatment With Methoxy Polyethyleneglycol-epoetin Beta After Study Completion
timeFrame: Month 12 or early discontinuation
measure: Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion
timeFrame: Month 12 or early discontinuation
measure: Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy
timeFrame: Month 12 or early discontinuation
measure: Number of Participants Satisfied With Treatment at Final Visit
timeFrame: Month 12 or early discontinuation
Secondary outcomes:
measure: Average Methoxy Polyethylene Glycol-epoetin Beta Dose
timeFrame: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12
Other outcomes:
Locations:
city: Saarlouis
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: