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Trial information
A Study of Intravenous or Subcutaneous Mircera in Chronic Kidney Disease Patients With Renal Anemia.
Status: No longer recruiting
Protocol number: BH18387
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the effect of long-term Mircera on hemoglobin levels in patients with chronic renal anemia
Brief summary: This single arm study will assess the long term efficacy, safety and tolerability of intravenous (iv) or subcutaneous (sc) Mircera in chronic kidney disease patients with renal anemia. Eligible patients will be those who are currently receiving stable maintenance therapy with Mircera in Phase II or III clinical studies. They will continue to receive Mircera at the same weekly dose and by the same route of administration (sc or iv) every 2 or every 4 weeks, as in the qualifying studies. The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals.
Target sample size is 1800.
Study phase: III
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety/Efficacy study
Condition: Anemia
Intervention type: Drug
Intervention name: methoxy polyethylene glycol-epoetin beta [Mircera]
Primary outcome: 1. Hb concentration over time Time frame: Throughout study
Key secondary outcomes: 1. Vital signs, AEs, laboratory parameters Time frame: Throughout study
Inclusion criteria: - adult patients >=18 years of age;
- chronic renal anemia;
- currently receiving Mircera as part of a clinical study.
Exclusion criteria: - women who are pregnant, breastfeeding or using unreliable birth control methods;
- administration of another investigational drug planned during the study period.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: September, 2004
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 - Gosford
- Liverpool
- Melbourne
- Parkville
- Sydney
- Woolloongabba
Austria Belgium - Aalst
- Bruxelles
- Gent
- Hasselt
- Leuven
- Liege
Czech Republic Denmark Finland France - Amiens
- Bayonne
- Bordeaux
- Boulogne
- Cabestany
- Caen
- Chambery
- Colmar
- Hyeres
- La Tronche
- Limoges
- Lyon
- Nantes
- Nimes
- Paris
- Perpignan
- Poitiers
- Rouen
- Saint Ouen
- Saint-Germain-En-Laye
- Tarbes
- Toulouse
Germany - Berlin
- Dortmund
- Erlangen
- München
- Nürnberg
- Stuttgart
- Villingen-Schwenningen
- Wiesbaden
- Wuppertal
Greece - Alexandroupolis
- Ioannina
- Larissa
- Piraeus
- Thessaloniki
Hungary - Budapest
- Debrecen
- Miskolc
- Pecs
Italy - Bergamo
- Cagliari
- Como
- Cremona
- Cuneo
- Genova
- Lecco
- Livorno
- Lodi
- Messina
- Modena
- Pavia
- Prato
- Reggio Calabria
- Venezia
Mexico Netherlands Norway Panama Poland - Gdansk
- Gdynia
- Kielce
- Krakow
- Lodz
- Poznan
- Rzeszow
- Szczecin
- Warszawa
- Wolomin
- Wroclaw
Russian Federation South Africa Spain - Alcorcon
- Alicante
- Almería
- Badalona
- Barcelona
- Córdoba
- La Coruna
- Madrid
- Malaga
- Oviedo
- Palma de Mallorca
- Salamanca
- Santander
- Santiago de Compostela
- Sevilla
Sweden Switzerland Thailand - Bangkok
- Chiang Mai
- Chonburi
- Phitsanulok
United Kingdom - Belfast
- Cambridge
- Dundee
- Exeter
- Glasgow
- Leicester
- London
- Salford
- Swansea
United States - Birmingham, AL
- Montgomery, AL
- Hot Springs, AR
- Encino, CA
- Irvine, CA
- Los Alamitos, CA
- Los Angeles, CA
- Monterey Park, CA
- Mountain View, CA
- Sacramento, CA
- San Diego , CA
- San Francisco, CA
- Stanford, CA
- Colorado Springs, CO
- Denver, CO
- Lakewood, CO
- Stamford, CT
- Ocala, FL
- Pembroke Pines, FL
- Augusta, GA
- Honolulu, HI
- Maywood, IL
- Louisville, KY
- Baton Rouge, LA
- Shreveport, LA
- Boston, MA
- Springfield, MA
- Detroit, MI
- Kalamazoo, MI
- Brooklyn Center, MN
- Columbus, MS
- Tupelo, MS
- St Louis, MO
- Hackensack, NJ
- Paterson, NJ
- Albuquerque, NM
- Bronx, NY
- Brooklyn, NY
- Flushing, NY
- Great Neck, NY
- Mineola, NY
- New York, NY
- Chapel Hill, NC
- Mount Airy, NC
- Raleigh, NC
- Cincinnati, OH
- Toledo, OH
- Oregon City, OR
- Portland, OR
- Allentown, PA
- Erie, PA
- Lewistown, PA
- Philadelphia, PA
- Pittsburgh, PA
- Ponce, PR
- Columbia, SC
- Orangeburg, SC
- Chattanooga, TN
- Nashville, TN
- Austin, TX
- Dallas, TX
- Houston, TX
- Burlington, VT
- Fairfax , VA
- Norfolk , VA
- Salem, VA
- Morgantown, WV
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