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Clinical Trials/NCT01309295
NCT01309295CompletedNot Applicable

A Prospective Study Evaluating the Efficacy and Safety of Mircera in Patients With CKD in Predialysis and Dialysis.

Hoffmann-La Roche0 sites250 target enrollmentStarted: November 2010Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
250
Primary Endpoint
Achievement of target hemoglobin (Hb) range of 10-12 g/dL according to Kidney Disease Outcomes Quality Initiative (KDQOI) guidelines
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This prospective observational study will assess the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in clinical practice in patients with chronic kidney disease, in pre-dialysis or on dialysis, initiated on Mircera treatment. Data from each patient will be collected over 12 months of treatment.

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 patients, >/= 18 years of age
  • •Chronic kidney disease, in pre-dialysis or dialysis
  • •Appropriate for treatment with Mircera according to current guidelines and Summary of Product Characteristics

Exclusion Criteria

  • •Anemia due to non-renal causes
  • •Pregnant or lactating women
  • •Uncontrolled hypertension
  • •Known hypersensitivity to methoxy polyethylene glycol-epoetin beta

Outcomes

Primary Outcomes

Achievement of target hemoglobin (Hb) range of 10-12 g/dL according to Kidney Disease Outcomes Quality Initiative (KDQOI) guidelines

Time Frame: 2 years

Maintenance of target Hb range (10-12 g/dL)

Time Frame: 2 years

Safety: Incidence of adverse events

Time Frame: 2 years

Secondary Outcomes

  • Frequency of visits and laboratory assessments(2 years)
  • Effect of compliance to treatment on Hb levels(2 years)
  • Dosing pattern in clinical practice, including dose adaptations(2 years)
  • Correlation between baseline clinical variables and time on target Hb level(2 years)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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