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Clinical Trials/NCT00442793
NCT00442793CompletedPhase 3

A Randomized, Open Label Study Comparing the Effect of Mircera and Epoetin Beta on Hemoglobin Response in Patients With Chronic Kidney Disease Who Are on Dialysis

Hoffmann-La Roche0 sites265 target enrollmentStarted: May 2007Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
265
Primary Endpoint
Hb response rate

Study Overview

Brief Summary

This 2 arm study will compare the effect on hemoglobin response of Mircera and epoetin beta, in patients with chronic renal anemia who are on dialysis. Eligible patients will be randomized to receive either Mircera (0.4 micrograms/kg i.v. every 2 weeks) or epoetin beta (3 times weekly, according to approved labelling). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

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

Inclusion Criteria

  • adult patients, >=18 years of age;
  • chronic renal anemia requiring dialysis;
  • maintenance hemodialysis or peritoneal dialysis for >=2 weeks before and during screening;
  • adequate iron status.

Exclusion Criteria

  • previous epoetin treatment within 8 weeks prior to screening;
  • failing renal graft in place;
  • bleeding episode necessitating transfusion within 8 weeks prior to screening;
  • poorly controlled hypertension;
  • previous treatment with Mircera.

Arms & Interventions

1

Experimental

Intervention: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)

2

Active Comparator

Intervention: Epoetin beta (Drug)

Outcomes

Primary Outcomes

Hb response rate

Time Frame: Weeks 0-24

Change in Hb concentration between baseline and evaluation period

Time Frame: Months 4-6

Secondary Outcomes

  • Hb over time(Throughout study)
  • Serum concentration of Mircera(Throughout study)
  • Time to Hb response(Throughout study)
  • RBC transfusions(Weeks 0-24)
  • AEs, laboratory parameters, vital signs(Throughout study)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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