Trial Information

Summary: A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.

Status: Terminated

Protocol Number: ML20336

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study comparing the pharmacoeconomic (Time and Motion) benefit of Mircera and epoetin alfa in patients with chronic kidney disease (stage V) on dialysis.

Brief Summary: This 2 arm study will compare 'time and motion' (provider time spent on anemia management) and effect on hemoglobin levels, of Mircera and epoetin alfa, in anemic patients with chronic kidney disease (CKD) on hemodialysis. Patients stable on iv epoetin alfa will be randomized either to receive standard of care therapy (epoetin alfa iv 3 times weekly), or to receive Mircera 120-360 micrograms iv, monthly. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 260.

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. Time spent on anemia treatment over evaluation period Time frame: Months 7-9 2. Change in Hb concentration from baseline Time frame: Month 7

Key Secondary Outcomes: 1. AEs, laboratory parameters Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 01/16/2007

Date Last Updated: 06/17/2008

Link To Trial Results

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Trial listings updated: June 30, 2008 at 5:03:27 PM