A Study of MIRCERA for the Intrapetient Variability of Hemoglobin Levels in Patients With Chronic Renal Anemia (RIVAL)
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1288
- 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
- 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)
Ahepa Hospital; 1St Dept. of Medicine
🇬🇷Thessaloniki, Greece
Kyanous Stavros of Patras, Renal Disease Therapy Unit
🇬🇷Patra, Greece
General Hospital Tzanio ; Nephrology
🇬🇷Piraeus, Greece
University Hospital Of Heraklion; Nefrologiki Clinic
🇬🇷Heraklion, Greece
General Hospital Of Athens G.Gennimatas; Nephrology
🇬🇷Athens, Greece
General Hospital Of West Attikis; Nephrology
🇬🇷Athens, Greece
University Hospital Attikon ; Pathology Clinic
🇬🇷Athens, Greece
Iatriko Athinon Clinic Dafnis; Nephrology Department
🇬🇷Daphni-athens, Greece
Attikon Center; Nephrology
🇬🇷Athens, Greece
Hospital henry dunant; Nephrology
🇬🇷Athens, Greece
General Hospital Hippokration of Athens; Nephrology
🇬🇷Athens, Greece
Kyanos Stavros Private Hospital; Nephrologic Clinic
🇬🇷Athens, Greece
Iaso General Private Clinic; Nephrology
🇬🇷Athens, Greece
General Hospital Of Lamias; Nephrology
🇬🇷Lamia, Greece
Eytychios Patsidis Center Of Haemodialysis
🇬🇷Larissa, Greece
General Hospital Of Dramas; Dialysis Center Unit
🇬🇷Drama, Greece
General Hospital Of Katerinis; Nephrology Unit
🇬🇷Katerini, Greece
Olympion Therapeytirion; Nefrology
🇬🇷Patra, Greece
General Hospital Agia Olga; Nephrology
🇬🇷Athen, Greece
Timios Stavros Clinic; Nephrology Department
🇬🇷Egaleo, Greece
Leivadia General Hospital; Nephrologic Clinic
🇬🇷Leivadia, Greece
Alfa Nefrodynamiki; Nefrology
🇬🇷Thessaloniki, Greece
Thessaliki Nossileytiki; Nephrology
🇬🇷Volos, Greece
General Hospital of Artas; Nephrology
🇬🇷Arta, Greece
Athinaiki Private Clinic
🇬🇷Athens, Greece
Univeristy Hospital of Larissa; Nephrology
🇬🇷Larissa, Greece
General Hospital Of Chalkidikis; Dialysis Center Unit
🇬🇷Polygyros, Greece
Alpha Nephrodynamiki Of Serres; Dialysis Center Unit
🇬🇷Serres, Greece
General Hospital Of Leykadas; Dialysis Center Unit
🇬🇷Leykada, Greece
Rodos General Hospital; Nephrologic Clinic
🇬🇷Rhodes, Greece
IPPOKRATES Private Dialysis Centre
🇬🇷Thessaloniki, Greece
General Hospital Of Thessalonikis Papageorgiou; Nephrology
🇬🇷Thessaloniki, Greece
General Hospital of Volos; Nephrology
🇬🇷Volos, Greece