Trial information
A Study of Mircera for the Treatment of Anemia in Dialysis Patients
Status: Completed
Protocol number: BA16736
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of intravenous Mircera on hemoglobin level/correction in dialysis patients with chronic kidney disease
Brief summary: This study will assess the efficacy and safety of Mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
Target sample size is 168.
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. Hemoglobin response rate Time frame: Weeks 1-24
Key secondary outcomes: 1. Hb over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, AEs, laboratory values
Time frame: Throughout study
Inclusion criteria:
- adult patients >=18 years of age;
- chronic renal anemia;
- dialysis therapy for at least 2 weeks before screening.
Exclusion criteria:
- women who are pregnant, breastfeeding or using unreliable birth control methods;
- administration of any investigational drug within 4 weeks before screening.
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: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Brazil
- Curitiba
- Ribeirão Preto
- Sao Paulo
Canada
- Winnipeg, MB
- St John'S
- Kingston, ON
- London, ON
- Toronto, ON
- Montreal, QC
Czech Republic
Greece
- Alexandroupolis
- Larissa
- Thessaloniki
Poland
- Gdansk
- Gdynia
- Krakow
- Lodz
- Poznan
- Szczecin
- Wolomin
- Wroclaw
Russian Federation
South Africa
Spain
Thailand
- Bangkok
- Chiang Mai
- Chonburi
United States
- Augusta, GA
- Springfield, MA
- Mineola, NY
- Burlington, VT
