Trial Information

Summary: A Study of Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients.

Status: Completed

Protocol Number: BA16740

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of the effect of maintenance subcutaneous Mircera on hemoglobin levels in dialysis patients with chronic kidney disease

Brief Summary: This study will assess the efficacy and safety of subcutaneous (sc) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving sc epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals. Target sample size is 465.

Study Phase: III

Study Design / Study Details:

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

Study Type:

Interventional

Condition: Anemia

Intervention Type: Drug

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

Primary Outcome: 1. Change in hemoglobin concentration Time frame: Weeks 1-36

Key Secondary Outcomes: 1. Number of patients maintaining average Hb concentration within +/- 1g/dL of average baseline Hb concentration Time frame: Weeks 29-36 2. RBC transfusions Time frame: Weeks 1-36 3. AEs, laboratory parameters, vital signs Time frame: Throughout study

Inclusion Criteria:

  • adult patients >=18 years of age;
  • chronic renal anemia;
  • on dialysis therapy for at least 12 weeks before screening;
  • receiving sc epoetin for at least 8 weeks before screening.

Exclusion Criteria:

  • women who are pregnant, breastfeeding or using unreliable birth control methods;
  • administration of another investigational drug within 4 weeks before screening, or during the study period.

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

Contact:

Research Site:
Located In:
Riverside, CA 92505
Telephone: 973-235-5000 or 800-526-6367

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Trial listings updated: July 21, 2008 at 2:19:58 PM


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