Trial Information

Summary: A Study of Intravenous or Subcutaneous Mircera in Chronic Kidney Disease Patients With Renal Anemia.

Status: No longer recruiting

Protocol Number: BH18387

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: An open-label study of the effect of long-term Mircera on hemoglobin levels in patients with chronic renal anemia

Brief Summary: This single arm study will assess the long term efficacy, safety and tolerability of intravenous (iv) or subcutaneous (sc) Mircera in chronic kidney disease patients with renal anemia. Eligible patients will be those who are currently receiving stable maintenance therapy with Mircera in Phase II or III clinical studies. They will continue to receive Mircera at the same weekly dose and by the same route of administration (sc or iv) every 2 or every 4 weeks, as in the qualifying studies. The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals. Target sample size is 1800.

Study Phase: III

Study Design / Study Details:

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

Study Type:

Condition: Anemia

Intervention Type: Drug

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

Primary Outcome: 1. Hb concentration over time Time frame: Throughout study

Key Secondary Outcomes: 1. Vital signs, 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, 2004

Trial Registration Date: 05/23/2005

Date Last Updated: 09/19/2008

Link To Trial Results

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Trial listings updated: October 6, 2008 at 2:42:52 PM