Trial information
A Study of Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients.
Status: Completed
Protocol number: BA16740
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of maintenance subcutaneous Mircera on hemoglobin levels in dialysis patients with chronic kidney disease
Brief summary: This study will assess the efficacy and safety of subcutaneous (sc) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving sc epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
Target sample size is
465.
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 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:
Belgium
- Bruxelles
- Edegem
- Gent
- Hasselt
Brazil
Czech Republic
Denmark
Finland
France
- Bayonne
- Boulogne
- Cabestany
- Caen
- Limoges
- Nimes
- Poitiers
- Reims
- Saint-Germain-En-Laye
- St Priest En Jarez
- Thionville
- Tours
Germany
- Bad Hersfeld
- Berlin
- Fulda
- Kaiserslautern
Hungary
- Budapest
- Debrecen
- Miskolc
- Pecs
Italy
- Cremona
- Lecco
- Modena
- Prato
- Venezia
Mexico
New Zealand
Panama
Poland
- Gdansk
- Kielce
- Krakow
- Wroclaw
South Africa
Spain
- Alcorcon
- Barcelona
- Madrid
- Palma de Mallorca
- Santiago de Compostela
Sweden
Taiwan
Thailand
United Kingdom
- Belfast
- Cambridge
- Dundee
- Exeter
- Leicester
- London
United States
- Hot Springs, AR
- Riverside, CA
- San Jose, CA
- Boston, MA
- Springfield, MA
- Raleigh, NC
- Winston-Salem, NC
- Toledo, OH
- Portland, OR
- Ponce, PR
- Dallas, TX
- Houston, TX
- San Antonio, TX
- Morgantown, WV
