Trial Information

Summary: LATINO Study: A Study of Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.

Status: Recruiting

Protocol Number: ML20881

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: An open label study to assess the maintenance of hemoglobin levels, safety and tolerability of once monthly administration of intravenous or subcutaneous Mircera in dialysis patients with chronic renal anemia

Brief Summary: This single arm study will assess the efficacy and safety of Mircera when administered once monthly, subcutaneously or intravenously, for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients currently receiving maintenance treatment with epoetin alfa will receive monthly injections of Mircera with a starting dose (120, 200 or 360 micrograms) derived from the dose of epoetin alfa they were receiving in the week preceding study start. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 200.

Study Phase: III

Study Design / Study Details:

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

Study Type:

Condition: Anemia

Intervention Type: Drug

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

Primary Outcome: 1. Percentage of patients maintaining average Hb concentration within target range of 10.5-12.5g/dL during evaluation period Time frame: Weeks 17-24

Key Secondary Outcomes: 1. Change in Hb concentration, and percentage patients maintaining Hb concentration in target range throughout evaluation period Time frame: Weeks 17-24 2. Mean time in target range; percentage of patients needing dose adjustments; incidence of RBC transfusions Time frame: Throughout study 3. 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: October, 2007

Trial Registration Date: 08/15/2007

Date Last Updated: 07/15/2008

Link To Trial Results

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Trial listings updated: July 21, 2008 at 2:33:38 PM