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Trial information
A Study of Mircera in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis
Status: Completed
Protocol number: BA16738
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of subcutaneous Mircera on hemoglobin level/correction in non-dialysis patients with chronic kidney disease
Brief summary: This study will assess the efficacy and safety of subcutaneous Mircera in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not 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 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. Hemoglobin response rate Time frame: Weeks 1-28
Key secondary outcomes: 1. Hb concentration over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, adverse events, laboratory values
Time frame: Throughout study
Inclusion criteria: - adult patients >=18 years of age;
- chronic kidney disease;
- anemia;
- not on dialysis therapy;
- not receiving epoetin.
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: 8/19/2008
Link to trial result
This trial was conducted at the following locations:Australia - Liverpool
- Melbourne
- Parkville
- Perth
Belgium Canada - Calgary, AB
- Edmonton, AB
- Kamloops, BC
- New Westminster, BC
- Vancouver, BC
- Winnipeg, MB
- St John'S
- Kitchener, ON
- London, ON
- Scarborough, ON
- Toronto, ON
- Montreal, QC
- Saskatoon, SK
France - Amiens
- Colmar
- Lyon
- Nantes
- Paris
- Perpignan
- Toulouse
- Vandoeuvre-Les-Nancy
Germany - Aschaffenburg
- Berlin
- Bonn
- Dortmund
- Tübingen
Greece - Alexandroupolis
- Athens
- Ioannina
- Piraeus
- Thessaloniki
Italy - Cagliari
- Cuneo
- Genova
- Lecco
- Lodi
- Pavia
- Prato
- Reggio Calabria
- Roma
Netherlands Spain - Almería
- Barcelona
- Lerida
- Madrid
- Palma de Mallorca
Sweden United Kingdom - Carshalton
- Leicester
- London
United States - Los Angeles, CA
- Mather, CA
- Stanford, CA
- Stamford, CT
- Ocala, FL
- Shreveport, LA
- Detroit, MI
- Flushing, NY
- Cincinnati, OH
- Allentown, PA
- San Juan, PR
- Columbia, SC
- Nashville, TN
- Austin, TX
- Dallas, TX
- Houston, TX
- Burlington, VT
- Salem, VA
- Morgantown, WV
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