Observational Study to Investigate the Long-term Effects of MIRCERA in Clinical Routine

Hoffmann-La Roche1,083 enrolled

Overview

This observational study will assess the effect of long-term treatment with Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patients with renal anemia. Data will be collected from each patient for at least 24 months.

Study Type

OBSERVATIONAL

Enrollment

1,083

Conditions

Anemia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients, \>/= 18 years of age * Patients with chronic kidney disease (CKD), stages IV and V * Treatment with Mircera according to label Exclusion Criteria: * Pregnant or breastfeeding women

Locations (1)

Unnamed facility

Lüdenscheid, Germany

Outcomes

Primary Outcomes

Hemoglobin Levels at Monthly Intervals

Hemoglobin levels were measured as grams/deciliter (g/dL).

Time frame: Prior to Day 1, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24

Percentage of Participants Within Pre-defined Range of Hemoglobin Values

Percentage of participants with hemoglobin values within the following pre-defined ranges is presented: 11-12 gram/deciliter (g/dL), 10-12 g/dL, 11-13 g/dL, and 10-13 g/dL.

Time frame: Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24

Average Methoxy Polyethylene Glycol-epoetin Beta Dose

Average methoxy polyethylene glycol-epoetin beta dose per application by study month. Mean values were taken when more than 1 application was documented for a participant during the time period considered.

Time frame: Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24

Data from ClinicalTrials.gov

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