Clinical trial NCT01356589: A Study of MIRCERA for the Intrapetient Variability of Hemoglobin Levels in Patients With Chronic Renal Anemia (RIVAL)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-05-19
Enrollment: 1288
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chronic kidney disease patients with anemia treated with Mircera

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With at Least One Hemoglobin Cycling
timeFrame: 9 months
Secondary outcomes:
measure: Number of Full Hemoglobin Cycles Per Participant
timeFrame: 9 months
measure: Percentage of Participants With Type 2 Diabetes Who Experienced at Least 1 Hemoglobin Cycling
timeFrame: 9 months
Other outcomes:
Locations:
city: Arta
country: Greece
facility: General Hospital of Artas; Nephrology
city: Athens
country: Greece
facility: Attikon Center; Nephrology
city: Athens
country: Greece
facility: Athinaiki Private Clinic
city: Athens
country: Greece
facility: Hospital henry dunant; Nephrology
city: Athens
country: Greece
facility: General Hospital Hippokration of Athens; Nephrology
city: Athens
country: Greece
facility: General Hospital Of Athens G.Gennimatas; Nephrology
city: Athens
country: Greece
facility: Kyanos Stavros Private Hospital; Nephrologic Clinic
city: Athens
country: Greece
facility: General Hospital Of West Attikis; Nephrology
city: Athens
country: Greece
facility: University Hospital Attikon ; Pathology Clinic
city: Athens
country: Greece
facility: Iaso General Private Clinic; Nephrology
city: Athen
country: Greece
facility: General Hospital Agia Olga; Nephrology
city: Daphni-athens
country: Greece
facility: Iatriko Athinon Clinic Dafnis; Nephrology Department
city: Drama
country: Greece
facility: General Hospital Of Dramas; Dialysis Center Unit
city: Egaleo
country: Greece
facility: Timios Stavros Clinic; Nephrology Department
city: Heraklion
country: Greece
facility: University Hospital Of Heraklion; Nefrologiki Clinic
city: Katerini
country: Greece
facility: General Hospital Of Katerinis; Nephrology Unit
city: Lamia
country: Greece
facility: General Hospital Of Lamias; Nephrology
city: Larissa
country: Greece
facility: Univeristy Hospital of Larissa; Nephrology
city: Larissa
country: Greece
facility: Eytychios Patsidis Center Of Haemodialysis
city: Leivadia
country: Greece
facility: Leivadia General Hospital; Nephrologic Clinic
city: Leykada
country: Greece
facility: General Hospital Of Leykadas; Dialysis Center Unit
city: Patra
country: Greece
facility: Kyanous Stavros of Patras, Renal Disease Therapy Unit
city: Patra
country: Greece
facility: Olympion Therapeytirion; Nefrology
city: Piraeus
country: Greece
facility: General Hospital Tzanio ; Nephrology
city: Polygyros
country: Greece
facility: General Hospital Of Chalkidikis; Dialysis Center Unit
city: Rhodes
country: Greece
facility: Rodos General Hospital; Nephrologic Clinic
city: Serres
country: Greece
facility: Alpha Nephrodynamiki Of Serres; Dialysis Center Unit
city: Thessaloniki
country: Greece
facility: Ahepa Hospital; 1St Dept. of Medicine
city: Thessaloniki
country: Greece
facility: IPPOKRATES Private Dialysis Centre
city: Thessaloniki
country: Greece
facility: General Hospital Of Thessalonikis Papageorgiou; Nephrology
city: Thessaloniki
country: Greece
facility: Alfa Nefrodynamiki; Nefrology
city: Volos
country: Greece
facility: Thessaliki Nossileytiki; Nephrology
city: Volos
country: Greece
facility: General Hospital of Volos; Nephrology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: