Trial information
A Study of Once-Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Pre-Dialysis Patients Not Currently Treated With ESA.
Status: Not yet recruiting
Protocol number: ML21467
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label study of the safety, tolerability and effect on hemoglobin levels of once-monthly subcutaneous Mircera in predialysis patients with chronic renal anemia not currently treated with ESA.
Brief summary: This single arm study will assess the efficacy and safety of subcutaneous Mircera for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with ESA. Eligible patients will receive monthly subcutaneous injections at an initial recommended dose of 1.2 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 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. Mean change in Hb concentration between baseline and Efficacy Evaluation Period (EEP). Time frame: Week 32
Key secondary outcomes: 1. Time to achievement of response Time frame: Throughout study
2. Percentage of patients whose Hb concentration remains within range 10.0-12.0g/dL Time frame: Throughout study
3. Percentage of patients whose average Hb concentration is within range 10.0 - 12.0g/dL Time frame: Throughout study
4. Mean time spent in Hb range of 10.0 - 12.0g/dL Time frame: Throughout study
5. Percentage of patients requiring dose adjustments; incidence of RBC transfusions; time to initiation of renal replacement therapy. Time frame: Throughout study
Inclusion criteria:
- adult patients, >=18 years of age;
- chronic renal anemia;
- no ESA therapy during previous 3 months;
- adequate iron status;
- rapid chronic kidney disease progression.
Exclusion criteria:
- transfusion of red blood cells during previous 2 months;
- poorly controlled hypertension requiring hospitalization in previous 6 months;
- significant acute or chronic bleeding.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: September, 2008
Trial registration date: 05/15/2008
Date last updated: 8/29/2008
Link to trial result
This trial will be conducted at the following locations:
Argentina
- Buenos Aires
- La Plata
- Santa Fe
- Tucuman
Brazil
- Belem
- Belo Horizonte
- Blumenau
- Botucatu
- Curitiba
- Rio De Janeiro
- Sao Paulo
- Taubaté
Chile
- Santiago
- Santiago de Chile
Colombia
- Barranquilla
- Cali
- Medellin
Costa Rica
Ecuador
El Salvador
Guatemala
Mexico
- Aguascalientes
- Guadalajara, Jalisco
- Merida
- Puebla
- Toluca
Panama
Peru
Uruguay
Venezuela
