Trial Information

Summary: A Study of Mircera for the Maintenance Treatment of Anemia in Dialysis Patients.

Status: No longer recruiting

Protocol Number: BH17847

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open label study to compare the effect of Mircera with that of darbepoetin alfa, administered intravenously at extended dosing intervals, for the maintenance treatment of anemia in patients with chronic kidney disease who are on hemodialysis.

Brief Summary: This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa, administered at extended dosing intervals, in the maintenance treatment of anemia in patients with chronic kidney disease who are on hemodialysis. Eligible patients receiving once-weekly intravenous darbepoetin alfa maintenance treatment will be randomized to receive either intravenous Mircera once a month (at a starting dose of 120, 200 or 360 micrograms/month, depending on the weekly dose of darbepoetin alfa prior to start of study) or intravenous darbepoetin alfa every 2 weeks before switching to once monthly administration. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 488.

Study Phase: III

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• Control: Active
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Anemia

Intervention Type: Drug

Intervention Name: methoxy polyethylene glycol-epoetin beta [Mircera]

Primary Outcome: 1. Percentage of patients with average Hb decrease from baseline <=1.0g/dL, and an average Hb >=10.5g/dL Time frame: Weeks 50 - 53

Key Secondary Outcomes: 1. Change in dose over time Time frame: Week 27 to months 11 and 12 2. AEs, laboratory parameters, vital signs Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: January, 2007

Trial Registration Date: 10/17/2006

Date Last Updated: 09/19/2008

Link To Trial Results

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Trial listings updated: October 6, 2008 at 2:35:06 PM