AnemiaPhase 3NCT00090753
A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia
A Phase 3 study testing Methoxy Polyethylene Glycol-Epoetin Beta, Epoetin alfa and Epoetin beta in people with Anemia, run by Hoffmann-La Roche at 249 sites in 27 countries.
Trial summary
This study assessed the long-term efficacy, safety, and tolerability of intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta in chronic kidney disease patients with renal anemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- Methoxy Polyethylene Glycol-Epoetin Beta, Epoetin alfa and Epoetin beta
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,228 participants
- Where
- 249 sitesin 27 countries
- Study dates
- Oct 2004to Dec 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- 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%
Who cannot join
- Poorly controlled hypertension
- 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
Trial locations and contacts
249 sites in 27 countries.
249 sites in 27 countries
United States83 sites
Study site
Albuquerque, New Mexico, 87131
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Allentown, Pennsylvania, 18103
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Atlanta, Georgia, 30342
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Augusta, Georgia, 30309
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Austin, Texas, 78758
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Baton Rouge, Louisiana, 70884
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Birmingham, Alabama, 35211
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Boston, Massachusetts, 02115
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Boston, Massachusetts, 02135
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Brooklyn, New York, 11203
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Brooklyn Center, Minnesota, 55430
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Burlington, Vermont, 05401
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Chapel Hill, North Carolina, 27599-7155
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Chattanooga, Tennessee, 37404
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Cincinnati, Ohio, 45267-0585
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Cleveland, Ohio, 44109
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Colorado Springs, Colorado, 80909
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Columbia, South Carolina, 29209
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Columbus, Mississippi, 39705
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Covina, California, 91723
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Dallas, Texas, 75216
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Denver, Colorado, 80262
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Detroit, Michigan, 48202-2689
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Detroit, Michigan, 48236
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Encino, California, 91356
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Erie, Pennsylvania, 16502
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Fairfax, Virginia, 22031
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Flushing, New York, 11355
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Great Neck, New York, 11021
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Hackensack, New Jersey, 07601
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Honolulu, Hawaii, 96813
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Hot Springs, Arkansas, 71901
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Houston, Texas, 77030
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Houston, Texas, 77054
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Houston, Texas, 77099
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Irvine, California, 92868
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Kalamazoo, Michigan, 49007
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Lakewood, Colorado, 80260
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Lewistown, Pennsylvania, 17044
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Los Alamitos, California, 90720
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Los Angeles, California, 90073
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Los Angeles, California, 90095
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Louisville, Kentucky, 40202-1718
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Maywood, Illinois, 60153
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Mineola, New York, 11501
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Mobile, Alabama, 36608
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Monterey Park, California, 91754
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Montgomery, Alabama, 36106
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Morgantown, West Virginia, 26506
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Mount Airy, North Carolina, 27030
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Mountain View, California, 94040
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Nashville, Tennessee, 37205
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Nashville, Tennessee, 37232
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New York, New York, 10021
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New York, New York, 10128
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Norfolk, Virginia, 23507-1901
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Ocala, Florida, 34471
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Orangeburg, South Carolina, 29118
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Orchard Park, New York, 14127
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Oregon City, Oregon, 97045
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Paterson, New Jersey, 07503
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Pembroke Pines, Florida, 33028
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Philadelphia, Pennsylvania, 19106
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Philadelphia, Pennsylvania, 19140
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Philadelphia, Pennsylvania, 19141
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Pittsburgh, Pennsylvania, 15224
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Portland, Oregon, 97201-2940
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Portland, Oregon, 97210
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Raleigh, North Carolina, 27609
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Sacramento, California, 95816-5119
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Salem, Virginia, 24153
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San Diego, California, 92120
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San Diego, California, 92123
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San Francisco, California, 94117
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Shreveport, Louisiana, 71101
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South Holland, Illinois, 60473
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Springfield, Massachusetts, 01107
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St Louis, Missouri, 63110
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Stamford, Connecticut, 06902
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Stanford, California, 94305
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The Bronx, New York, 10467
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Toledo, Ohio, 43606
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Tupelo, Mississippi, 38801
Spain26 sites
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A Coruña, 15006
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Alcorcón, 28922
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Alicante, 03010
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Almería, 04009
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Badalona, 08915
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Barcelona, 08003
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Barcelona, 08035
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Barcelona, 08036
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Bilbao, 48013
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Córdoba, 14004
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L'Hospitalet de Llobregat, 08907
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Lleida, 25198
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Madrid, 28006
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Madrid, 28007
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Madrid, 28041
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Madrid, 28046
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Madrid, 28222
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Madrid, 28805
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Málaga, 29010
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Oviedo, 33006
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Palma de Mallorca, 07014
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Palma de Mallorca, 07198
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Salamanca, 37008
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Santander, 39008
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Santiago de Compostela, 15706
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Seville, 41013
France25 sites
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Bayonne, 64115
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Bois-Guillaume, 76233
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Bordeaux, 33076
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Boulogne, 62321
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Cabestany, 66330
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Caen, 14033
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Chambéry, 73001
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Colmar, 68024
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Hyères, 83400
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La Tronche, 38700
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Limoges, 87042
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Lyon, 69437
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Montpellier, 34295
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Nantes, 44093
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Nîmes, 30029
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Paris, 75908
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Perpignan, 66046
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Poitiers, 86021
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Saint-Germain-en-Laye, 78100
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Saint-Ouen, 93400
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Salouël, 80480
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Tarbes, 65013
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Thionville, 57126
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Toulouse, 31059
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Tours, 37044
Italy16 sites
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Bergamo, 24128
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Cagliari, 91034
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Cremona, 26100
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Cuneo, 12100
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Genova, 16132
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Lecco, 23900
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Livorno, 57100
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Lodi, 26900
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Messina, 98158
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Mestre, 30174
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Modena, 41100
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Pavia, 27100
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Prato, 50047
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Reggio Calabria, 89100
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S Fermo Della Battaglia, 22020
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Venezia, 30122
United Kingdom13 sites
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Belfast, BT9 7LJ
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Cambridge, CB2 2QQ
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Carshalton, SM5 1AA
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Dundee, DD1 9SY
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Exeter, EX2 5DW
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Glasgow, G4 OSF
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Leicester, LE5 4PW
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London, E1 1BB
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London, SE1 9RT
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London, SE22 8PT
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London, SW17 0RE
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Salford, M6 8HD
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Swansea, SA6 6NL
Germany11 sites
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Bad Hersfeld, 36251
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Berlin, 12045
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Dortmund, 44263
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Erlangen, 91054
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München, 80804
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Nuremberg, 90431
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Stuttgart, 70191
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Villingen-Schwenningen, 78054
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Wiesbaden, 65191
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Wiesloch, 69168
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Wuppertal, 42103
Poland11 sites
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Gdansk, 80-211
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Gdynia, 81-519
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Kielce, 25-736
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Krakow, 31-501
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Lodz, 90-153
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Poznan, 60-355
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Rzeszów, 35-055
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Szczecin, 70-111
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Warsaw, 02-006
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Wołomin, 05-200
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Wroclaw, 50-417
Australia7 sites
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Clayton, 3186
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Gosford, 2250
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Liverpool, 1871
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Parkville, 3050
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Perth, 6847
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Sydney, NSW 2148
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Woolloongabba, 4102
Belgium7 sites
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Aalst, 9300
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Brussels, 1200
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Edegem, 2650
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Ghent, 9000
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Hasselt, 3500
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Leuven, 3000
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Liège, 4000
Thailand7 sites
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Bangkok, 10330
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Bangkok, 10400
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Bangkok, 10700
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Bangkok
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Chiang Mai, 50200
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Chon Buri
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Phitsanulok, 65000
Greece5 sites
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Alexandroupoli, 68100
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Ioannina, 45500
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Larissa, 41110
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Piraeus, 18536
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Thessaloniki, 54629
Hungary5 sites
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Budapest, 1076
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Budapest, 1134
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Debrecen, 4032
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Miskolc, 3526
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Pécs, 7624
Russia5 sites
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Moscow, 123182
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Moscow, 125101
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Moscow, 129110
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Saint Petersburg, 195067
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Saint Petersburg, 197089
Sweden4 sites
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Huddinge, 14186
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Karlstad, 65185
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Stockholm, 18288
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Umeå, 90185
Czechia3 sites
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Liberec, 460 63
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Ostrava, 708 52
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Pilsen, 304 60
Denmark3 sites
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Aalborg, 9100
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Odense, 5000
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Roskilde, 4000
South Africa3 sites
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Cape Town, 7925
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Durban
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Soweto
Switzerland3 sites
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Aarau, 5001
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Lausanne, 1003
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Lausanne, 1011
About this study
Official title: An Open-label, Multi-center Study to Document the Efficacy, Safety, and Tolerability of Long-term Administration of RO0503821 in Patients With Chronic Renal Anemia
This study assessed the long-term efficacy, safety, and tolerability of intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta in chronic kidney disease patients with renal anemia. Eligible patients were those who were receiving stable maintenance therapy with methoxy polyethylene glycol-epoetin beta or erythropoiesis stimulating agents (ESAs) in Phase II or III clinical studies. They continued to receive methoxy polyethylene glycol-epoetin beta or comparator ESAs at the same weekly dose and by the same route of administration (sc or iv) as in the qualifying studies.
- Conditions
- Anemia
- Being tested
- Methoxy Polyethylene Glycol-Epoetin Beta, Epoetin alfa, Epoetin beta, Darbepoetin alfa
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methoxy Polyethylene Glycol-Epoetin BetaDrug
Also called RO0503821, Mircera
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 alfaDrug
Epoetin alfa was provided with commercial packaging in English with country-specific labels (10,000 IU, 20,000 IU).
Epoetin betaDrug
Epoetin beta was provided with commercial packaging in English with country-specific labels (50,000 IU, 100,000 IU).
Darbepoetin alfaDrug
Darbepoetin alfa was provided with commercial packaging in English with country-specific labels (vials and PFSs in various strengths).
| Study group | Role | What they receive |
|---|---|---|
| Methoxy Polyethylene Glycol-Epoetin Beta | Experimental | 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. Receives: Drug: Methoxy Polyethylene Glycol-Epoetin Beta |
| Comparator ESA | Active comparator | 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. Receives: Drug: Epoetin alfa; Drug: Epoetin beta; Drug: Darbepoetin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation
Blood samples were collected at each study visit, that is, every 4 weeks for the first 12 weeks, every 12 weeks until week 105 of the first study period, every 3 months thereafter, and at the end of study or the last visit if the patient discontinued the study prematurely.
Measured: Baseline to the end of the study (Up to 49 Months)
Secondary outcomes (1)
Percentage of Patients Who Had at Least 1 Adverse Event
See the adverse events section of the results for more information.
Measured: From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2004 (estimated)
- Study startOct 2004
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00090753
- Sponsor's protocol ID
- BH18387
- Status last verified
- Feb 2012
- First submitted
- 3 Sep 2004
- Last updated
- 14 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center Study to Document the Efficacy, Safety, and Tolerability of Long-term Administration of RO0503821 in Patients With Chronic Renal Anemia
- ClinicalTrials.gov ID
- NCT00090753
- Acronym / sponsor ID
- BH18387
- Conditions
- Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,228 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 6 Sep 2004 (estimated)
- Results
- Posted 5 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study assessed the long-term efficacy, safety, and tolerability of intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta in chronic kidney disease patients with renal anemia. Eligible patients were those who were receiving stable maintenance therapy with methoxy polyethylene glycol-epoetin beta or erythropoiesis stimulating agents (ESAs) in Phase II or III clinical studies. They continued to receive methoxy polyethylene glycol-epoetin beta or comparator ESAs at the same weekly dose and by the same route of administration (sc or iv) as in the qualifying studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methoxy Polyethylene Glycol-Epoetin Beta | Experimental | Drug: Methoxy Polyethylene Glycol-Epoetin BetaPatients 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. |
| Comparator ESA | Active comparator | Drug: Epoetin alfa, Drug: Epoetin beta, Drug: Darbepoetin alfaPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent
- 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%
Key exclusion criteria (8 listed)
- Poorly controlled hypertension
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methoxy Polyethylene Glycol-Epoetin BetaAlso: RO0503821, MirceraMethoxy 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. | Drug | Methoxy Polyethylene Glycol-Epoetin Beta |
| Epoetin alfaEpoetin alfa was provided with commercial packaging in English with country-specific labels (10,000 IU, 20,000 IU). | Drug | Comparator ESA |
| Epoetin betaEpoetin beta was provided with commercial packaging in English with country-specific labels (50,000 IU, 100,000 IU). | Drug | Comparator ESA |
| Darbepoetin alfaDarbepoetin alfa was provided with commercial packaging in English with country-specific labels (vials and PFSs in various strengths). | Drug | Comparator ESA |
Primary outcome
Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation
Time frame: Baseline to the end of the study (Up to 49 Months)
Blood samples were collected at each study visit, that is, every 4 weeks for the first 12 weeks, every 12 weeks until week 105 of the first study period, every 3 months thereafter, and at the end of study or the last visit if the patient discontinued the study prematurely.
1 secondary outcome
Percentage of Patients Who Had at Least 1 Adverse Event
Time frame: From first dose of study drug to date of last contact or 30 days after last drug dose (Up to 49 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
249 sites in 27 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methoxy Polyethylene Glycol-Epoetin Beta, Epoetin alfa and Epoetin beta in people with Anemia, run by Hoffmann-La Roche at 249 sites in 27 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 249 sites in United States, Spain, France, Italy, United Kingdom and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Hemoglobin Concentration to the Last Month of Study Participation (time frame: Baseline to the end of the study (Up to 49 Months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2012.