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

Retrospective Study on Intrapatient VAriabiLity of the Hemoglobin Levels in Anemic CKD Patients in Predialysis (Stage 3-4) and Dialysis (Stage 5) Treated With MIRCERA® (RIVAL Study)

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 Overview

• Status: Completed
• Conditions: Anemia

• Study Type: Observational
• Enrollment (Actual): 1288

Contacts and Locations

Study Locations

• Greece
  • Arta, Greece, 47100
    • General Hospital of Artas; Nephrology
  • Athen, Greece, 14233
    • General Hospital Agia Olga; Nephrology
  • Athens, Greece, 11362
    • Attikon Center; Nephrology
  • Athens, Greece, 11521
    • Athinaiki Private Clinic
  • Athens, Greece, 11528
    • Kyanos Stavros Private Hospital; Nephrologic Clinic
  • Athens, Greece, 15562
    • Iaso General Private Clinic; Nephrology
  • Athens, Greece, 11527
    • General Hospital Of Athens G.Gennimatas; Nephrology
  • Athens, Greece, 12351
    • General Hospital Of West Attikis; Nephrology
  • Athens, Greece, 124 61
    • University Hospital Attikon ; Pathology Clinic
  • Athens, Greece, 11526
    • Hospital henry dunant; Nephrology
  • Athens, Greece, 11527
    • General Hospital Hippokration of Athens; Nephrology
  • Daphni-athens, Greece, 17237
    • Iatriko Athinon Clinic Dafnis; Nephrology Department
  • Drama, Greece, 66100
    • General Hospital Of Dramas; Dialysis Center Unit
  • Egaleo, Greece, 12244
    • Timios Stavros Clinic; Nephrology Department
  • Heraklion, Greece, 71110
    • University Hospital Of Heraklion; Nefrologiki Clinic
  • Katerini, Greece
    • General Hospital Of Katerinis; Nephrology Unit
  • Lamia, Greece, 35100
    • General Hospital Of Lamias; Nephrology
  • Larissa, Greece, 41 110
    • Univeristy Hospital of Larissa; Nephrology
  • Larissa, Greece, 41335
    • Eytychios Patsidis Center Of Haemodialysis
  • Leivadia, Greece, 32100
    • Leivadia General Hospital; Nephrologic Clinic
  • Leykada, Greece, 31100
    • General Hospital Of Leykadas; Dialysis Center Unit
  • Patra, Greece, 26225
    • Kyanous Stavros of Patras, Renal Disease Therapy Unit
  • Patra, Greece, 26443
    • Olympion Therapeytirion; Nefrology
  • Piraeus, Greece, 18536
    • General Hospital Tzanio ; Nephrology
  • Polygyros, Greece, 63100
    • General Hospital Of Chalkidikis; Dialysis Center Unit
  • Rhodes, Greece, 85100
    • Rodos General Hospital; Nephrologic Clinic
  • Serres, Greece
    • Alpha Nephrodynamiki Of Serres; Dialysis Center Unit
  • Thessaloniki, Greece, 57500
    • Alfa Nefrodynamiki; Nefrology
  • Thessaloniki, Greece, 54636
    • Ahepa Hospital; 1St Dept. of Medicine
  • Thessaloniki, Greece, 54643
    • IPPOKRATES Private Dialysis Centre
  • Thessaloniki, Greece, 56403
    • General Hospital Of Thessalonikis Papageorgiou; Nephrology
  • Volos, Greece, 38221
    • Thessaliki Nossileytiki; Nephrology
  • Volos, Greece, 38222
    • General Hospital of Volos; Nephrology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Chronic kidney disease patients with anemia treated with Mircera

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	9 months

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2010
• Primary Completion (Actual): July 31, 2012
• Study Completion (Actual): July 31, 2012

Study Registration Dates

• First Submitted: May 18, 2011
• First Submitted That Met QC Criteria: May 18, 2011
• First Posted (Estimate): May 19, 2011

Study Record Updates

• Last Update Posted (Actual): July 5, 2017
• Last Update Submitted That Met QC Criteria: June 13, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: ML25289