Evaluation of Monthly Darbepoetin Alfa Dosing for Correction of Anemia in Non-dialysis Chronic Kidney Disease
A Multicenter, Randomised, Double-Blind Study Comparing De Novo Once Monthly and Once Every 2 Week Darbepoetin Alfa Dosing for the Correction of Anemia in Subjects With Chronic Kidney Disease Not Receiving Dialysis
2 other identifiers
interventional
358
21 countries
149
Brief Summary
The purpose of this study is to determine whether once monthly (QM) dosing of darbepoetin alfa is non-inferior to that of once every 2 week (Q2W) dosing of darbepoetin alfa for the correction of anemia in patients with Chronic Kidney Disease who are not receiving dialysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2009
Typical duration for phase_3
149 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2009
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedFirst Posted
Study publicly available on registry
June 22, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedResults Posted
Study results publicly available
June 4, 2014
CompletedJune 4, 2014
May 1, 2014
2.8 years
May 28, 2009
December 5, 2013
May 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hb Change Between Baseline and the Evaluation Period (Average of Weeks 29-33)
The Adjusted Analysis is the primary analysis and includes treatment group and baseline Hb value as covariates. Non-inferiority is concluded if the lower limit of the 95% confidence interval for the mean difference is above -0.5g/dL.
Baseline Week 33
Secondary Outcomes (53)
Achievement of Both a Hb >= 10.0 g/dL and a >= 1.0 g/dL Increase From Baseline at Any Time Point Following de Novo Darbepoetin Alfa Administration.
Baseline to Week 33
Hb at Baseline
Baseline
Hb at Week 3
Week 3
Hb at Week 5
Week 5
Hb at Week 7
Week 7
- +48 more secondary outcomes
Study Arms (2)
Q2W
ACTIVE COMPARATORQ2W administration of darbepoetin alfa.
QM
ACTIVE COMPARATORQM administration of darbepoetin alfa
Interventions
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.
Eligibility Criteria
You may qualify if:
- ≥ 18 years of age
- 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%
You may not qualify if:
- Upper or lower GI bleeding within 6 months before enrolment
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (157)
Research Site
Gosford, New South Wales, 2250, Australia
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Liverpool, New South Wales, 2170, Australia
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New Lambton, New South Wales, 2305, Australia
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Randwick, New South Wales, 2031, Australia
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Cairns, Queensland, 4870, Australia
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Box Hill, Victoria, 3128, Australia
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Footscray, Victoria, 3011, Australia
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Parkville, Victoria, 3050, Australia
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Reservoir, Victoria, 3073, Australia
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Brussels, 1020, Belgium
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Brussels, 1200, Belgium
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Edegem, 2650, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Roeselare, 8800, Belgium
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Pleven, 5800, Bulgaria
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Sofia, 1431, Bulgaria
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Sofia, 1709, Bulgaria
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Varna, 9010, Bulgaria
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Brno, 615 00, Czechia
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Chrudim, 537 27, Czechia
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Jilemnice, 514 15, Czechia
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Kladno, 272 59, Czechia
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Liberec, 460 03, Czechia
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Nový Jičín, 741 01, Czechia
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Pilsen, 301 00, Czechia
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Prague, 100 34, Czechia
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Prague, 149 00, Czechia
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Prague, 160 00, Czechia
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Prague, 169 00, Czechia
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Prague, 181 02, Czechia
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Praha 4 - Nusle, 140 00, Czechia
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Slavkov u Brna, 684 01, Czechia
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Sternberk, 785 01, Czechia
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Ústí nad Orlicí, 562 18, Czechia
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Ã…rhus, 8200, Denmark
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Roskilde, 4000, Denmark
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Viborg, 8800, Denmark
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Tallinn, 10617, Estonia
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Tallinn, 13419, Estonia
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Annonay, 07100, France
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Creil, 60100, France
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Grenoble, 38000, France
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Metz, 57000, France
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Montivilliers, 76290, France
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Nice, 06000, France
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Poissy, 78300, France
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Reims, 51092, France
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Rouen, 76031, France
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Saint-Priest-en-Jarez, 42270, France
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Bernkastel-Kues, 54470, Germany
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Coesfeld, 48653, Germany
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Düsseldorf, 40210, Germany
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Hamburg, 22297, Germany
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Leverkusen, 51373, Germany
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Alexandroupoli, 68100, Greece
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Athens, 11528, Greece
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Larissa, 41110, Greece
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Thessaloniki, 54636, Greece
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Thessaloniki, 54642, Greece
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Baja, 6500, Hungary
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Budapest, 1115, Hungary
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Debrecen, 4012, Hungary
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Esztergom, 2500, Hungary
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Győr, 9023, Hungary
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Kaposvár, 7400, Hungary
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Pécs, 7624, Hungary
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Szekszárd, 7100, Hungary
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Szombathely, 9700, Hungary
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Zalaegerszeg, 8900, Hungary
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Ashkelon, 78278, Israel
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Hadera, 38100, Israel
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Jerusalem, 91031, Israel
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Albano Laziale RM, 00041, Italy
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Ancona, 60125, Italy
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Cagliari, 09134, Italy
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Florence, 50141, Italy
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Lecco, 23900, Italy
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Napoli, 80131, Italy
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Pavia, 27100, Italy
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Roma, 00189, Italy
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Torino, 10126, Italy
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Torino, 10154, Italy
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Daugavpils, 5417, Latvia
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Riga, 1001, Latvia
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Riga, 1002, Latvia
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Riga, 1038, Latvia
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Valmiera, 4201, Latvia
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Ventspils, 3600, Latvia
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Saltillo, Coahuila, 25230, Mexico
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Guadalajara, Jalisco, 44140, Mexico
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Cuernavaca, Morelos, 62448, Mexico
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Querétaro, Querétaro, 76178, Mexico
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San Luis Potosí City, San Luis PotosÃ-, 78240, Mexico
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Choszczno, 73-200, Poland
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Golub-Dobrzyń, 87-400, Poland
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Koszalin, 75-581, Poland
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Kościerzyna, 83-400, Poland
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Legnica, 59-220, Poland
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Lodz, 90-549, Poland
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Lodz, 93-120, Poland
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Lublin, 20-954, Poland
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Poznan, 61-289, Poland
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Warsaw, 04-749, Poland
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Zamość, 87-100, Poland
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Evora, 7000-811, Portugal
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Faro, 8000-386, Portugal
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Lisbon, 1649-035, Portugal
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Porto, 4099-001, Portugal
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Setúbal, 2910-446, Portugal
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Bucharest, 010731, Romania
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Bucharest, 014461, Romania
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Bucharest, 022328, Romania
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Bucharest, 050098, Romania
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Iași, 700503, Romania
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Timișoara, 300736, Romania
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Moscow, 117036, Russia
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Moscow, 123183, Russia
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Moscow, 125284, Russia
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Saint Petersburg, 191104, Russia
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Saint Petersburg, 195067, Russia
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Saint Petersburg, 196247, Russia
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Yekaterinburg, 620102, Russia
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Belgrade, 11000, Serbia
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Krgujevac, 34000, Serbia
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Zemun, 11080, Serbia
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Bratislava, 831 03, Slovakia
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Galanta, 924 22, Slovakia
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Námestovo, 029 01, Slovakia
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Šaľa, 927 19, Slovakia
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Trstená, 028 01, Slovakia
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Zvolen, 960 01, Slovakia
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Jesenice, 4270, Slovenia
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Novo Mesto, 8000, Slovenia
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Slovenj Gradec, 2380, Slovenia
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Šempeter pri Gorici, 5290, Slovenia
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Jaén, AndalucÃ-a, 23007, Spain
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Barcelona, Cataluña, 08036, Spain
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L'Hospitalet de Llobregat, Cataluña, 08907, Spain
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Madrid, Madrid, 28046, Spain
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Majadahonda, Madrid, 28222, Spain
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Galdakao, PaÃ-s Vasco, 48960, Spain
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Birmingham, B9 5SS, United Kingdom
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Brighton, BN2 5BE, United Kingdom
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Cambridge, CB2 2QQ, United Kingdom
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Coventry, CV2 2DX, United Kingdom
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Glasgow, G11 6NT, United Kingdom
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Hull, HU3 2JZ, United Kingdom
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Leicester, LE5 4PW, United Kingdom
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Newcastle upon Tyne, NE7 7DN, United Kingdom
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Salford, M6 8HD, United Kingdom
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Shrewsbury, SY3 8XQ, United Kingdom
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Stevenage, SG1 4AB, United Kingdom
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Stoke-on-Trent, ST4 7LN, United Kingdom
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Swansea, SA6 6NL, United Kingdom
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Wolverhampton, WV10 0QP, United Kingdom
Related Publications (1)
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.
PMID: 24506498DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Amgen Inc.
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2009
First Posted
June 22, 2009
Study Start
June 1, 2009
Primary Completion
April 1, 2012
Study Completion
May 1, 2012
Last Updated
June 4, 2014
Results First Posted
June 4, 2014
Record last verified: 2014-05