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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01356589
First received: May 18, 2011
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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


Condition
Anemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Proportion of patients with hemoglobin cycling (oscillation in hemoglobin of >/= 1.5 g/dL over 8 weeks) [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Within patient frequency of full hemoglobin cycles (oscillation in hemoglobin of >/= 1.5 g/dL over 8 weeks) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Incidence of hemoglobin cycling according to baseline demographic and clinical characteristics (age, gender, cause of renal disease, diabetes, dialysis or predialysis status) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Proportion of patients with diabetes type II who experienced hemoglobin cycling within the 9 months observation period [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Incidence of hemoglobin cycling according to baseline demographic and clinical characteristics (age, gender, cause of renal disease, diabetes, dialysis or predialysis status) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 1288
Study Start Date: September 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Chronic kidney disease patients with anemia treated with Mircera

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01356589

Locations
Greece
Arta, Greece, 47100
Athen, Greece, 14233
Athens, Greece, 11528
Athens, Greece, 11521
Athens, Greece, 11527
Athens, Greece, 15562
Athens, Greece, 11526
Athens, Greece, 11362
Athens, Greece, 124 61
Athens, Greece, 12351
Daphni-athens, Greece, 17237
Drama, Greece, 66100
Egaleo, Greece, 12244
Heraklion, Greece, 71110
Katerini, Greece
Lamia, Greece, 35100
Larissa, Greece, 41 110
Larissa, Greece, 41335
Leivadia, Greece, 32100
Leykada, Greece, 31100
Patra, Greece, 26225
Patra, Greece, 26443
Piraeus, Greece, 18536
Polygyros, Greece, 63100
Rhodes, Greece, 85100
Serres, Greece
Thessaloniki, Greece, 56403
Thessaloniki, Greece, 54636
Thessaloniki, Greece, 57500
Thessaloniki, Greece, 54643
Volos, Greece, 38222
Volos, Greece, 38221
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01356589     History of Changes
Other Study ID Numbers: ML25289
Study First Received: May 18, 2011
Last Updated: August 4, 2014
Health Authority: Greece: National Organization of Medicines

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on September 16, 2014