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Trial information
A Study of Intravenous or Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients
Status: Completed
Protocol number: BA17284
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of maintenance Mircera administered with pre-filled syringes on hemoglobin levels in anemic dialysis patients with chronic kidney disease
Brief summary: This study will assess the efficacy and safety of intravenous (iv) or subcutaneous (sc) Mircera, administered with pre-filled syringes, as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv or sc epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
Target sample size is
264.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
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 iv or 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 Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 05/23/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:Canada - Ottawa, ON
- Toronto, ON
- Greenfield Park, QC
- Montreal, QC
France - Chambery
- Hyeres
- Le Kremlin-Bicetre
- Nantes
- Paris
- Rouen
Germany - Erlangen
- München
- Nürnberg
Italy Poland Portugal Spain Taiwan - Kaohsiung
- Taichung
- Taipei
Thailand United Kingdom - Glasgow
- London
- Salford
- Swansea
United States - Covina, CA
- Los Alamitos, CA
- Los Angeles, CA
- San Diego , CA
- Tampa, FL
- Honolulu, HI
- South Holland, IL
- Baton Rouge, LA
- Shreveport, LA
- Boston, MA
- Kalamazoo, MI
- Columbus, MS
- Tupelo, MS
- St Louis, MO
- Hackensack, NJ
- Flushing, NY
- New York, NY
- Orchard Park, NY
- Cleveland, OH
- Oregon City, OR
- Erie, PA
- Lewistown, PA
- Philadelphia, PA
- Ponce, PR
- San Juan, PR
- Columbia, SC
- Charlottesville, VA
- Norfolk , VA
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