Trial Information

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

Status: Completed

Protocol Number: BA16528

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of the effect of different dosing intervals of subcutaneous Mircera on hemoglobin level/correction in patients with chronic renal anemia

Brief Summary: This study will evaluate the efficacy and safety of different subcutaneous starting doses and dosing frequencies of Mircera in anemic patients with chronic kidney disease not yet on dialysis. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals. Target sample size is 54.

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. Hemoglobin levels Time frame: Throughout study

Key Secondary Outcomes: 1. Hematocrit, reticulocyte count. 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: 07/15/2008

Link To Trial Results

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Trial listings updated: July 21, 2008 at 2:16:29 PM