Trial Information

Summary: A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease, Not on Dialysis.

Status: Recruiting

Protocol Number: BH20051

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open label study to compare the effect of monthly subcutaneous Mircera with that of darbepoetin alfa, given according to local label, on the management of anemia in patients with chronic kidney disease not on dialysis

Brief Summary: This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the treatment of anemia in patients with chronic kidney disease who are not on dialysis and who are receiving subcutaneous darbepoetin alfa maintenance therapy. Patients will be randomized either to remain on darbepoetin alfa therapy as per local label, or to switch to monthly subcutaneous Mircera, at a starting dose of 120, 200 or 360 micrograms, depending on the weekly dose of darbepoetin alfa administered prior to the first dose of Mircera. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 264.

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. Change in Hb concentration between baseline and evaluation period Time frame: Months 7-9

Key Secondary Outcomes: 1. Hb concentration over time Time frame: Throughout study 2. RBC transfusions Time frame: To month 9 3. AEs, laboratory parameters Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: September, 2007

Trial Registration Date: 03/07/2007

Date Last Updated: 09/19/2008

Link To Trial Results

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Trial listings updated: October 6, 2008 at 2:42:14 PM