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

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ClinicalTrials.gov Identifier: NCT01356589
Recruitment Status : Completed
First Posted : May 19, 2011
Results First Posted : December 28, 2015
Last Update Posted : July 5, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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.

Condition or disease
Anemia

Study Design
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Study Type : Observational
Actual Enrollment : 1288 participants
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)
Actual Study Start Date : September 30, 2010
Actual Primary Completion Date : July 31, 2012
Actual Study Completion Date : July 31, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Groups and Cohorts
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Group/Cohort
Cohort


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With at Least One Hemoglobin Cycling [ Time Frame: 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 :
  1. Number of Full Hemoglobin Cycles Per Participant [ Time Frame: 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.

  2. Percentage of Participants With Type 2 Diabetes Who Experienced at Least 1 Hemoglobin Cycling [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01356589


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01356589    
Other Study ID Numbers: ML25289
First Posted: May 19, 2011    Key Record Dates
Results First Posted: December 28, 2015
Last Update Posted: July 5, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases