Trial Information

Summary: A Study of Intravenous (iv) Mircera in Hemodialysis Patients With Chronic Renal Anemia

Status: Completed

Protocol Number: BA16285

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of dose conversion factors for maintenance intravenous Mircera in hemodialysis patients with chronic renal anemia

Brief Summary: This study will determine the appropriate dose and frequency of administration of iv Mircera maintenance therapy in hemodialysis patients with chronic renal anemia who were previously receiving iv epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals. Target sample size is 90.

Study Phase: II

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 from baseline over time under constant dosing regimen Time frame: Throughout study

Key Secondary Outcomes: 1. Change in hematocrit from baseline over time under constant dosing regimen. Vital signs, adverse events, laboratory values 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: 08/18/2008

Link To Trial Results

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Trial listings updated: September 2, 2008 at 1:46:10 PM