A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia
NCT ID: NCT00090753
Last Updated: 2012-02-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1228 participants
INTERVENTIONAL
2004-10-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Methoxy Polyethylene Glycol-Epoetin Beta
Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
Methoxy Polyethylene Glycol-Epoetin Beta
Methoxy polyethylene glycol-epoetin beta was provided as a sterile single-use injectable solution in 2-mL glass vials containing 1 mL solution or in single-use sterile pre-filled syringes (PFSs) containing 0.3 mL or 0.6 mL injectable solution. The injectable solution was available in vials with the following strengths: 50, 100, 200, 400, and 1000 μg/mL. The injectable solution was available in PFSs with the following strengths: 30, 40, 50, 60, 75, 100, 120, 150, 200, and 250 μg/0.3 mL; and 360 and 400 μg/0.6 mL.
Comparator ESA
Patients received the same comparator ESA \[epoetin alfa, epoetin beta, or darbepoetin alfa\] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
Epoetin alfa
Epoetin alfa was provided with commercial packaging in English with country-specific labels (10,000 IU, 20,000 IU).
Epoetin beta
Epoetin beta was provided with commercial packaging in English with country-specific labels (50,000 IU, 100,000 IU).
Darbepoetin alfa
Darbepoetin alfa was provided with commercial packaging in English with country-specific labels (vials and PFSs in various strengths).
Interventions
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Methoxy Polyethylene Glycol-Epoetin Beta
Methoxy polyethylene glycol-epoetin beta was provided as a sterile single-use injectable solution in 2-mL glass vials containing 1 mL solution or in single-use sterile pre-filled syringes (PFSs) containing 0.3 mL or 0.6 mL injectable solution. The injectable solution was available in vials with the following strengths: 50, 100, 200, 400, and 1000 μg/mL. The injectable solution was available in PFSs with the following strengths: 30, 40, 50, 60, 75, 100, 120, 150, 200, and 250 μg/0.3 mL; and 360 and 400 μg/0.6 mL.
Epoetin alfa
Epoetin alfa was provided with commercial packaging in English with country-specific labels (10,000 IU, 20,000 IU).
Epoetin beta
Epoetin beta was provided with commercial packaging in English with country-specific labels (50,000 IU, 100,000 IU).
Darbepoetin alfa
Darbepoetin alfa was provided with commercial packaging in English with country-specific labels (vials and PFSs in various strengths).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adult patients (≥ 18 years old) with chronic renal anemia
* Maintenance erythropoietic therapy with methoxy polyethylene glycol-epoetin beta or a protocol-specified reference medication (epoetin alfa formulated with human albumin, epoetin beta or darbepoetin alfa) in one of the following studies: BA16528\[NCT00048048\], BA16285\[NCT00048035\], BA16286\[NCT00364832\], BA16736\[NCT00077597\], BA16738\[NCT00081471\], BA16739\[NCT00077610\], BA16740\[NCT00077623\], BA17283\[NCT00077766\] and BA17284\[NCT00081484\]
* Hemoglobin (Hb) concentration between 10.5 and 13.0 g/dL
* Adequate iron status defined as serum ferritin ≥ 100 ng/mL or Transferrin Saturation (TSAT)≥ 20% or percentage of hypochromic red blood cells (RBCs) \< 10%
Exclusion Criteria
* History of epileptic seizure
* Pure red cell aplasia
* Chronic congestive heart failure \[New York Heart Association (NYHA) IV\]
* High likelihood of early withdrawal or interruption of the study
* Active malignant disease (except non-melanoma skin cancer)
* Life expectancy less than 12 months
* Pregnancy or breast-feeding
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Palma de Mallorca, , Spain
Salamanca, , Spain
Santander, , Spain
Santiago de Compostela, , Spain
Seville, , Spain
Huddinge, , Sweden
Karlstad, , Sweden
Stockholm, , Sweden
Umeå, , Sweden
Aarau, , Switzerland
Lausanne, , Switzerland
Birmingham, Alabama, United States
Mobile, Alabama, United States
Montgomery, Alabama, United States
Hot Springs, Arkansas, United States
Covina, California, United States
Encino, California, United States
Irvine, California, United States
Los Alamitos, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Monterey Park, California, United States
Mountain View, California, United States
Sacramento, California, United States
San Diego, California, United States
San Diego, California, United States
San Francisco, California, United States
Stanford, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Lakewood, Colorado, United States
Stamford, Connecticut, United States
Ocala, Florida, United States
Pembroke Pines, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Honolulu, Hawaii, United States
Maywood, Illinois, United States
South Holland, Illinois, United States
Louisville, Kentucky, United States
Baton Rouge, Louisiana, United States
Shreveport, Louisiana, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Springfield, Massachusetts, United States
Detroit, Michigan, United States
Detroit, Michigan, United States
Kalamazoo, Michigan, United States
Brooklyn Center, Minnesota, United States
Columbus, Mississippi, United States
Tupelo, Mississippi, United States
St Louis, Missouri, United States
Hackensack, New Jersey, United States
Paterson, New Jersey, United States
Albuquerque, New Mexico, United States
Brooklyn, New York, United States
Flushing, New York, United States
Great Neck, New York, United States
Mineola, New York, United States
New York, New York, United States
New York, New York, United States
Orchard Park, New York, United States
The Bronx, New York, United States
Chapel Hill, North Carolina, United States
Mount Airy, North Carolina, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Toledo, Ohio, United States
Oregon City, Oregon, United States
Portland, Oregon, United States
Portland, Oregon, United States
Allentown, Pennsylvania, United States
Erie, Pennsylvania, United States
Lewistown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Columbia, South Carolina, United States
Orangeburg, South Carolina, United States
Chattanooga, Tennessee, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Burlington, Vermont, United States
Fairfax, Virginia, United States
Norfolk, Virginia, United States
Salem, Virginia, United States
Morgantown, West Virginia, United States
Clayton, , Australia
Gosford, , Australia
Liverpool, , Australia
Parkville, , Australia
Perth, , Australia
Sydney, , Australia
Woolloongabba, , Australia
Graz, , Austria
Aalst, , Belgium
Brussels, , Belgium
Edegem, , Belgium
Ghent, , Belgium
Hasselt, , Belgium
Leuven, , Belgium
Liège, , Belgium
Liberec, , Czechia
Ostrava, , Czechia
Pilsen, , Czechia
Aalborg, , Denmark
Odense, , Denmark
Roskilde, , Denmark
HUS, , Finland
Tampere, , Finland
Bayonne, , France
Bois-Guillaume, , France
Bordeaux, , France
Boulogne, , France
Cabestany, , France
Caen, , France
Chambéry, , France
Colmar, , France
Hyères, , France
La Tronche, , France
Limoges, , France
Lyon, , France
Montpellier, , France
Nantes, , France
Nîmes, , France
Paris, , France
Perpignan, , France
Poitiers, , France
Saint-Germain-en-Laye, , France
Saint-Ouen, , France
Salouël, , France
Tarbes, , France
Thionville, , France
Toulouse, , France
Tours, , France
Bad Hersfeld, , Germany
Berlin, , Germany
Dortmund, , Germany
Erlangen, , Germany
München, , Germany
Nuremberg, , Germany
Stuttgart, , Germany
Villingen-Schwenningen, , Germany
Wiesbaden, , Germany
Wiesloch, , Germany
Wuppertal, , Germany
Alexandroupoli, , Greece
Ioannina, , Greece
Larissa, , Greece
Piraeus, , Greece
Thessaloniki, , Greece
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Miskolc, , Hungary
Pécs, , Hungary
Bergamo, , Italy
Cagliari, , Italy
Cremona, , Italy
Cuneo, , Italy
Genova, , Italy
Lecco, , Italy
Livorno, , Italy
Lodi, , Italy
Messina, , Italy
Mestre, , Italy
Modena, , Italy
Pavia, , Italy
Prato, , Italy
Reggio Calabria, , Italy
S Fermo Della Battaglia, , Italy
Venezia, , Italy
Cuernavaca, , Mexico
Mexico City, , Mexico
Heerlen, , Netherlands
Trondheim, , Norway
Panama City, , Panama
Gdansk, , Poland
Gdynia, , Poland
Kielce, , Poland
Krakow, , Poland
Lodz, , Poland
Poznan, , Poland
Rzeszów, , Poland
Szczecin, , Poland
Warsaw, , Poland
Wołomin, , Poland
Wroclaw, , Poland
Setúbal, , Portugal
Ponce, , Puerto Rico
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Cape Town, , South Africa
Durban, , South Africa
Soweto, , South Africa
A Coruña, , Spain
Alcorcón, , Spain
Alicante, , Spain
Almería, , Spain
Badalona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Bilbao, , Spain
Córdoba, , Spain
L'Hospitalet de Llobregat, , Spain
Lleida, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Málaga, , Spain
Oviedo, , Spain
Palma de Mallorca, , Spain
Lausanne, , Switzerland
Taichung, , Taiwan
Taipei, , Taiwan
Bangkok, , Thailand
Bangkok, , Thailand
Bangkok, , Thailand
Bangkok, , Thailand
Chiang Mai, , Thailand
Chon Buri, , Thailand
Phitsanulok, , Thailand
Belfast, , United Kingdom
Cambridge, , United Kingdom
Carshalton, , United Kingdom
Dundee, , United Kingdom
Exeter, , United Kingdom
Glasgow, , United Kingdom
Leicester, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Salford, , United Kingdom
Swansea, , United Kingdom
Countries
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Other Identifiers
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BH18387
Identifier Type: -
Identifier Source: org_study_id
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