Trial information
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 type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
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:
- adult patients, >=18 years of age;
- chronic renal anemia;
- hemodialysis or peritoneal dialysis, with same mode of dialysis for >=3 months before and throughout screening period;
- stable maintenance epoetin alfa therapy for past 2 months.
Exclusion criteria:
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension requiring interruption of epoetin alfa in past 6 months;
- acute or chronic bleeding during previous 2 months.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: October, 2007
Trial registration date: 08/15/2007
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
Argentina
- Buenos Aires
- Córdoba
- Santa Fe
Brazil
- Aracajú
- Curitiba
- Fortaleza
- Sao Paulo
Chile
Colombia
Ecuador
Mexico
- Cuernavaca
- Mexico City
- Monterrey
Peru
Uruguay
Venezuela
