Trial Information

Summary: A Study of Subcutaneous Mircera Once Monthly in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis.

Status: Recruiting

Protocol Number: NH20052

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: An open-label, randomized, multicenter, parallel-group study to demonstrate correction of anemia using once every 4 weeks subcutaneous injections of Mircera in patients with chronic kidney disease who are not on dialysis.

Brief Summary: This 2 arm study will compare the efficacy and safety of subcutaneous Mircera and subcutaneous darbepoetin in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving erythropoiesis-stimulating agents (ESA). Patients will be randomized to receive either Mircera once every 4 weeks, at a starting dose of 1.2 micrograms/kg, or darbepoetin alfa once weekly, at a starting dose of 0.45 micrograms/kg. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 300.

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. Hb response rate, and change in average Hb concentration Time frame: Weeks 0-28

Key Secondary Outcomes: 1. Hb values and change over time; time to target Hb response; incidence of RBC transfusions; percentage of patients with stable Hb response; number of dose adjustments required Time frame: Throughout study 2. Percentage of patients with >=1 Hb >12g/dL Time frame: Weeks 0-8 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

Anticipated Start Date: December, 2007

Trial Registration Date: 11/14/2007

Date Last Updated: 09/19/2008

Link To Trial Results

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Trial listings updated: October 6, 2008 at 2:46:03 PM