Evaluation of Monthly Darbepoetin Alfa Dosing for Correction of Anemia in Non-dialysis Chronic Kidney Disease
NCT ID: NCT00925587
Last Updated: 2014-06-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
358 participants
INTERVENTIONAL
2009-06-30
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Q2W
Q2W administration of darbepoetin alfa.
darbepoetin alfa
Drug administered either Q2W or QM using a prefilled syringe. Allowable doses of: 10, 20, 30, 40, 50, 60, 80, 100, 130, 150, 200, 300, 400 or 600 mcg.
QM
QM administration of darbepoetin alfa
darbepoetin alfa
Drug administered either Q2W or QM using a prefilled syringe. Allowable doses of: 10, 20, 30, 40, 50, 60, 80, 100, 130, 150, 200, 300, 400 or 600 mcg.
Interventions
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darbepoetin alfa
Drug administered either Q2W or QM using a prefilled syringe. Allowable doses of: 10, 20, 30, 40, 50, 60, 80, 100, 130, 150, 200, 300, 400 or 600 mcg.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of chronic kidney disease with eGFR of 15-59 mL/min/1.73 m2 (MDRD equation)
* Two consecutive screening Hb values taken at least 7 days apart must each be \<10.0 g/dL
* TSAT ≥ 15%
Exclusion Criteria
* ESA use within 12 weeks before enrolment
* Uncontrolled hypertension
* Systemic haematologic disorders
* Prior history within 12 weeks before enrollment of events including: Acute myocardial ischemia, unstable angina, myocardial infarction, hospitalization for congestive heart failure, stroke or transient ischaemic attack, limb ischaemia, deep vein thrombosis, thromboembolism.
* Grand mal seizure within 6 months prior to enrolment
* Evidence of, or received chemotherapy or radiation therapy for, a malignancy within 5 years prior to enrolment.
* Red blood cell transfusion within 12 weeks prior to enrolment
* Androgen therapy within 8 weeks prior to enrolment
* Pregnancy or breast feeding, or inadequate contraception
* Currently receiving immunosuppressive therapy
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Gosford, New South Wales, Australia
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Liverpool, New South Wales, Australia
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New Lambton, New South Wales, Australia
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Randwick, New South Wales, Australia
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Cairns, Queensland, Australia
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Box Hill, Victoria, Australia
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Footscray, Victoria, Australia
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Parkville, Victoria, Australia
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Reservoir, Victoria, Australia
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Brussels, , Belgium
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Brussels, , Belgium
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Edegem, , Belgium
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Ghent, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Roeselare, , Belgium
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Pleven, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Brno, , Czechia
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Chrudim, , Czechia
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Jilemnice, , Czechia
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Kladno, , Czechia
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Liberec, , Czechia
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Nový Jičín, , Czechia
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Pilsen, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Praha 4 - Nusle, , Czechia
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Slavkov u Brna, , Czechia
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Sternberk, , Czechia
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Ústí nad Orlicí, , Czechia
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Ã…rhus, , Denmark
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Roskilde, , Denmark
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Viborg, , Denmark
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Tallinn, , Estonia
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Tallinn, , Estonia
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Annonay, , France
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Creil, , France
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Grenoble, , France
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Metz, , France
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Montivilliers, , France
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Nice, , France
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Poissy, , France
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Reims, , France
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Rouen, , France
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Saint-Priest-en-Jarez, , France
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Bernkastel-Kues, , Germany
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Coesfeld, , Germany
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Düsseldorf, , Germany
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Hamburg, , Germany
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Leverkusen, , Germany
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Alexandroupoli, , Greece
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Athens, , Greece
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Larissa, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Baja, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Esztergom, , Hungary
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Győr, , Hungary
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Kaposvár, , Hungary
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Pécs, , Hungary
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Szekszárd, , Hungary
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Szombathely, , Hungary
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Zalaegerszeg, , Hungary
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Ashkelon, , Israel
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Hadera, , Israel
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Jerusalem, , Israel
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Albano Laziale RM, , Italy
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Ancona, , Italy
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Cagliari, , Italy
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Florence, , Italy
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Lecco, , Italy
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Napoli, , Italy
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Pavia, , Italy
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Roma, , Italy
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Torino, , Italy
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Torino, , Italy
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Daugavpils, , Latvia
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Riga, , Latvia
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Riga, , Latvia
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Riga, , Latvia
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Valmiera, , Latvia
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Ventspils, , Latvia
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Saltillo, Coahuila, Mexico
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Guadalajara, Jalisco, Mexico
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Cuernavaca, Morelos, Mexico
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Querétaro, Querétaro, Mexico
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San Luis Potosí City, San Luis PotosÃ-, Mexico
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Choszczno, , Poland
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Golub-Dobrzyń, , Poland
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Koszalin, , Poland
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Kościerzyna, , Poland
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Legnica, , Poland
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Lodz, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Zamość, , Poland
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Evora, , Portugal
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Faro, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Setúbal, , Portugal
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Iași, , Romania
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Timișoara, , Romania
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Yekaterinburg, , Russia
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Belgrade, , Serbia
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Krgujevac, , Serbia
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Zemun, , Serbia
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Bratislava, , Slovakia
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Galanta, , Slovakia
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Námestovo, , Slovakia
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Šaľa, , Slovakia
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Trstená, , Slovakia
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Zvolen, , Slovakia
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Jesenice, , Slovenia
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Novo Mesto, , Slovenia
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Slovenj Gradec, , Slovenia
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Šempeter pri Gorici, , Slovenia
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Jaén, AndalucÃ-a, Spain
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Barcelona, Cataluña, Spain
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L'Hospitalet de Llobregat, Cataluña, Spain
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Madrid, Madrid, Spain
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Majadahonda, Madrid, Spain
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Galdakao, PaÃ-s Vasco, Spain
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Birmingham, , United Kingdom
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Brighton, , United Kingdom
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Cambridge, , United Kingdom
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Coventry, , United Kingdom
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Glasgow, , United Kingdom
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Hull, , United Kingdom
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Leicester, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Salford, , United Kingdom
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Shrewsbury, , United Kingdom
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Stevenage, , United Kingdom
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Stoke-on-Trent, , United Kingdom
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Swansea, , United Kingdom
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Wolverhampton, , United Kingdom
Countries
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References
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Roger SD, Kolmakova E, Fung M, Malecki R, Vinhas J, Dellanna F, Thomas M, Manamley N, Ferenczi S. Darbepoetin alfa once monthly corrects anaemia in patients with chronic kidney disease not on dialysis. Nephrology (Carlton). 2014 May;19(5):266-74. doi: 10.1111/nep.12214.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2006-003173-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20060163
Identifier Type: -
Identifier Source: org_study_id
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