Trial Information

Summary: A Study of Intravenous or Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients

Status: Completed

Protocol Number: BA17284

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of the effect of maintenance Mircera administered with pre-filled syringes on hemoglobin levels in anemic dialysis patients with chronic kidney disease

Brief Summary: This study will assess the efficacy and safety of intravenous (iv) or subcutaneous (sc) Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv or sc epoetin. 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 hemoglobin concentration Time frame: Weeks 1-36

Key Secondary Outcomes: 1. Number of patients maintaining average Hb concentration within +/- 1g/dL of average baseline Hb concentration Time frame: Weeks 29-36 2. RBC transfusions Time frame: Weeks 1-36 3. 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

Trial Registration Date: 05/23/2005

Date Last Updated: 07/15/2008

Link To Trial Results

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Trial listings updated: July 21, 2008 at 2:19:07 PM