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

Completed

• Conditions: Anemia

• Registration Number: NCT01356589
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-30
• Study First Submitted: 2011-05-18
• Study First Submitted QC: 2011-05-18
• Study First Posted: 2011-05-19
• Primary Completion: 2012-07-31
• Study Completion: 2012-07-31
• Results First Submitted: 2015-11-23
• Results First Submitted QC: 2015-11-23
• Results First Posted: 2015-12-28
• Status Verified: 2017-05
• Last Update Submitted: 2017-06-13
• Last Update Posted: 2017-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1288

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With at Least One Hemoglobin Cycling	9 months	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Type 2 Diabetes Who Experienced at Least 1 Hemoglobin Cycling	9 months	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.
Number of Full Hemoglobin Cycles Per Participant	9 months	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.

Trial Locations

Locations (33)

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

Iaso General Private Clinic; Nephrology; 🇬🇷 Athens, Greece

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