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Clinical Trials/NCT01902628
NCT01902628CompletedNot Applicable

An Observational, Prospective Study to Evaluate the Hemoglobin Levels in Non-Dialysis Chronic Kidney Disease Subjects With Renal Anemia, Treated With MIRCERA (Methoxy-Polyethylene-Glycol-Epoetin Beta)

Hoffmann-La Roche24 sites in 1 country437 target enrollmentStarted: July 15, 2013Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
437
Locations
24
Primary Endpoint
Percentage of Participants With Hemoglobin Levels Within 10.0 - 12.0 g/dL at Months 8-10
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This prospective observational study evaluated the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease participants on dialysis with renal anemia. Participants initiated on treatment with Mircera according to the Summary of Product Characteristics and standard clinical practice were followed for 10 months.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Adult participants, >/= 18 years of age
  • •Participants with chronic kidney disease (CKD) not on dialysis with renal anemia (CKD Stages 3 & 4)
  • •Initiated on Mircera treatment (participants may have received Mircera treatment for up to 3 months before study enrollment)
  • •Life expectancy > 10 months

Exclusion Criteria

  • •Malignant disease
  • •Significant or acute bleeding
  • •Poorly controlled hypertension
  • •Blood transfusion during the previous 2 months
  • •Hypersensitivity to Mircera or any of its excipients

Outcomes

Primary Outcomes

Percentage of Participants With Hemoglobin Levels Within 10.0 - 12.0 g/dL at Months 8-10

Time Frame: Months 8 to 10

g/dL = grams per deciliter

Secondary Outcomes

  • Percentage of Participants With Hemoglobin Levels Within the Following Ranges: 11.0 - 12.0 g/dL, 11.0 - 13.0 g/dL, and 10.0 - 13.0 g/dL at Months 8-10(Months 8 to 10)
  • Percentage of Participants With MIRCERA Dose Adjustments(Up to 10 months)
  • Number of Participants With Serious Adverse Events (AEs) and Non-Serious AEs(Up to 10 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (24)

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