A Study of MIRCERA for the Intrapetient Variability of Hemoglobin Levels in Patients With Chronic Renal Anemia (RIVAL)

Hoffmann-La Roche1,288 enrolled

Overview

This retrospective observational study will assess the incidence of hemoglobin cycling in chronic kidney disease (stage 3, 4, and 5) patients with renal anemia treated with Mircera (methoxy polyethylene glycol-epoetin beta). Data will be collected from each patient from a 9-month treatment period.

Study Type

OBSERVATIONAL

Enrollment

1,288

Conditions

Anemia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients, \>/= 18 years of age * Chronic kidney disease in predialysis (stage 3 and 4) and dialysis * Renal anemia treated with Mircera according to label for at least 9 months before date of signed informed consent Exclusion Criteria: * Participation in an interventional clinical trial within the retrospective observation period * Contraindications to Mircera administration as per label or judged by the investigator

Locations (33)

Outcomes

Primary Outcomes

Percentage of Participants With at Least One Hemoglobin Cycling

Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of greater than or equal to (\>=) 1.5 gram per deciliter (g/dL) and a duration \>=8 weeks.

Time frame: 9 months

Secondary Outcomes

Number of Full Hemoglobin Cycles Per Participant

Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of \>=1.5 g/dL and a duration \>=8 weeks.

Time frame: 9 months

Percentage of Participants With Type 2 Diabetes Who Experienced at Least 1 Hemoglobin Cycling

Hemoglobin cycling was defined as 1 or more cycles of oscillation in hemoglobin with an amplitude of \>=1.5 g/dL and a duration \>=8 weeks.

Time frame: 9 months

Data from ClinicalTrials.gov

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Timios Stavros Clinic; Nephrology Department

Aigáleo, Greece

General Hospital of Artas; Nephrology

Arta, Greece

Attikon Center; Nephrology

Athens, Greece

Athinaiki Private Clinic

Athens, Greece

Hospital henry dunant; Nephrology

Athens, Greece

General Hospital Hippokration of Athens; Nephrology

Athens, Greece

General Hospital Of Athens G.Gennimatas; Nephrology

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

...and 23 more locations