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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00925587




Registration number
NCT00925587
Ethics application status
Date submitted
28/05/2009
Date registered
18/06/2009
Date last updated
15/05/2014

Titles & IDs
Public title
Evaluation of Monthly Darbepoetin Alfa Dosing for Correction of Anemia in Non-dialysis Chronic Kidney Disease
Scientific title
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
Secondary ID [1] 0 0
2006-003173-27
Secondary ID [2] 0 0
20060163
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anemia 0 0
Chronic Kidney Disease 0 0
Condition category
Condition code
Blood 0 0 0 0
Anaemia
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - darbepoetin alfa

Active Comparator: Q2W - Q2W administration of darbepoetin alfa.

Active Comparator: QM - QM administration of darbepoetin alfa


Treatment: Drugs: 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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline Week 33
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline to Week 33
Secondary outcome [2] 0 0
Hb at Baseline
Timepoint [2] 0 0
Baseline
Secondary outcome [3] 0 0
Hb at Week 3
Timepoint [3] 0 0
Week 3
Secondary outcome [4] 0 0
Hb at Week 5
Timepoint [4] 0 0
Week 5
Secondary outcome [5] 0 0
Hb at Week 7
Timepoint [5] 0 0
Week 7
Secondary outcome [6] 0 0
Hb at Week 9
Timepoint [6] 0 0
Week 9
Secondary outcome [7] 0 0
Hb at Week 11
Timepoint [7] 0 0
Week 11
Secondary outcome [8] 0 0
Hb at Week 13
Timepoint [8] 0 0
Week 13
Secondary outcome [9] 0 0
Hb at Week 15
Timepoint [9] 0 0
Week 15
Secondary outcome [10] 0 0
Hb at Week 17
Timepoint [10] 0 0
Week 17
Secondary outcome [11] 0 0
Hb at Week 19
Timepoint [11] 0 0
Week 19
Secondary outcome [12] 0 0
Hb at Week 21
Timepoint [12] 0 0
Week 21
Secondary outcome [13] 0 0
Hb at Week 23
Timepoint [13] 0 0
Week 23
Secondary outcome [14] 0 0
Hb at Week 25
Timepoint [14] 0 0
Week 25
Secondary outcome [15] 0 0
Hb at Week 27
Timepoint [15] 0 0
Week 27
Secondary outcome [16] 0 0
Hb at Week 29
Timepoint [16] 0 0
Week 29
Secondary outcome [17] 0 0
Hb at Week 31
Timepoint [17] 0 0
Week 31
Secondary outcome [18] 0 0
Hb at Week 33
Timepoint [18] 0 0
Week 33
Secondary outcome [19] 0 0
Darbepoetin Alfa Dose at Week 1 - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [19] 0 0
Week 1
Secondary outcome [20] 0 0
Darbepoetin Alfa Dose at Week 3 - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [20] 0 0
Week 3
Secondary outcome [21] 0 0
Darbepoetin Alfa Dose at Week 5 - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [21] 0 0
Week 5
Secondary outcome [22] 0 0
Darbepoetin Alfa Dose at Week 7 - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [22] 0 0
Week 7
Secondary outcome [23] 0 0
Darbepoetin Alfa Dose at Week 9 - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [23] 0 0
Week 9
Secondary outcome [24] 0 0
Darbepoetin Alfa Dose at Week 11 - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [24] 0 0
Week 11
Secondary outcome [25] 0 0
Darbepoetin Alfa Dose at Week 13 - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [25] 0 0
Week 13
Secondary outcome [26] 0 0
Darbepoetin Alfa Dose at Week 15 - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [26] 0 0
Week 15
Secondary outcome [27] 0 0
Darbepoetin Alfa Dose at Week 17 - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [27] 0 0
Week 17
Secondary outcome [28] 0 0
Darbepoetin Alfa Dose at Week 19 - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [28] 0 0
Week 19
Secondary outcome [29] 0 0
Darbepoetin Alfa Dose at Week 21 - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [29] 0 0
Week 21
Secondary outcome [30] 0 0
Darbepoetin Alfa Dose at Week 23 - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [30] 0 0
Week 23
Secondary outcome [31] 0 0
Darbepoetin Alfa Dose at Week 25 - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [31] 0 0
Week 25
Secondary outcome [32] 0 0
Darbepoetin Alfa Dose at Week 27 - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [32] 0 0
Week 27
Secondary outcome [33] 0 0
Darbepoetin Alfa Dose at Week 29 - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [33] 0 0
Week 29
Secondary outcome [34] 0 0
Darbepoetin Alfa Dose at Week 31 - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [34] 0 0
Week 31
Secondary outcome [35] 0 0
Darbepoetin Alfa Dose During the Evaluation Period (Average of Weeks 29-33) - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [35] 0 0
Weeks 29-33
Secondary outcome [36] 0 0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 3 - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [36] 0 0
Week 3
Secondary outcome [37] 0 0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 5 - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [37] 0 0
Week 5
Secondary outcome [38] 0 0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 7 - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [38] 0 0
Week 7
Secondary outcome [39] 0 0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 9 - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [39] 0 0
Week 9
Secondary outcome [40] 0 0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 11 - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [40] 0 0
Week 11
Secondary outcome [41] 0 0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 13 - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [41] 0 0
Week 13
Secondary outcome [42] 0 0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 15 - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [42] 0 0
Week 15
Secondary outcome [43] 0 0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 17 - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [43] 0 0
Week 17
Secondary outcome [44] 0 0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 19 - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [44] 0 0
Week 19
Secondary outcome [45] 0 0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 21 - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [45] 0 0
Week 21
Secondary outcome [46] 0 0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 23 - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [46] 0 0
Week 23
Secondary outcome [47] 0 0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 25 - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [47] 0 0
Week 25
Secondary outcome [48] 0 0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 27 - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [48] 0 0
Week 27
Secondary outcome [49] 0 0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 29 - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [49] 0 0
Week 29
Secondary outcome [50] 0 0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 31 - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [50] 0 0
Week 31
Secondary outcome [51] 0 0
Dose of Darbepoetin Alfa at the First Achievement of a Hb =10.0 g/dL and a =1.0 g/dL Increase From Baseline (Weeks 1-33) - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [51] 0 0
Weeks 1-33
Secondary outcome [52] 0 0
Time to First Achievement of a Hb =10.0 g/dL and a =1.0 g/dL Increase From Baseline (Weeks 1-33)
Timepoint [52] 0 0
Weeks 1-33
Secondary outcome [53] 0 0
Ratio of Darbepoetin Alfa Dose to Baseline at the Evalaution Period (Average of Weeks 29-33) - Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Timepoint [53] 0 0
Evaluation Period

Eligibility
Key inclusion criteria
- = 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%
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Research Site - Gosford
Recruitment hospital [2] 0 0
Research Site - Liverpool
Recruitment hospital [3] 0 0
Research Site - New Lambton
Recruitment hospital [4] 0 0
Research Site - Randwick
Recruitment hospital [5] 0 0
Research Site - Cairns
Recruitment hospital [6] 0 0
Research Site - Box Hill
Recruitment hospital [7] 0 0
Research Site - Footscray
Recruitment hospital [8] 0 0
Research Site - Parkville
Recruitment hospital [9] 0 0
Research Site - Reservoir
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
2305 - New Lambton
Recruitment postcode(s) [4] 0 0
2031 - Randwick
Recruitment postcode(s) [5] 0 0
4870 - Cairns
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
3011 - Footscray
Recruitment postcode(s) [8] 0 0
3050 - Parkville
Recruitment postcode(s) [9] 0 0
3073 - Reservoir
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Bruxelles
Country [2] 0 0
Belgium
State/province [2] 0 0
Edegem
Country [3] 0 0
Belgium
State/province [3] 0 0
Gent
Country [4] 0 0
Belgium
State/province [4] 0 0
Leuven
Country [5] 0 0
Belgium
State/province [5] 0 0
Liège
Country [6] 0 0
Belgium
State/province [6] 0 0
Roeselare
Country [7] 0 0
Bulgaria
State/province [7] 0 0
Pleven
Country [8] 0 0
Bulgaria
State/province [8] 0 0
Sofia
Country [9] 0 0
Bulgaria
State/province [9] 0 0
Varna
Country [10] 0 0
Czech Republic
State/province [10] 0 0
Brno
Country [11] 0 0
Czech Republic
State/province [11] 0 0
Chrudim
Country [12] 0 0
Czech Republic
State/province [12] 0 0
Jilemnice
Country [13] 0 0
Czech Republic
State/province [13] 0 0
Kladno
Country [14] 0 0
Czech Republic
State/province [14] 0 0
Liberec 1
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Novy Jicin
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Plzen
Country [17] 0 0
Czech Republic
State/province [17] 0 0
Praha 10
Country [18] 0 0
Czech Republic
State/province [18] 0 0
Praha 4 - Nusle
Country [19] 0 0
Czech Republic
State/province [19] 0 0
Praha 4
Country [20] 0 0
Czech Republic
State/province [20] 0 0
Praha 6
Country [21] 0 0
Czech Republic
State/province [21] 0 0
Praha 8
Country [22] 0 0
Czech Republic
State/province [22] 0 0
Slavkov u Brna
Country [23] 0 0
Czech Republic
State/province [23] 0 0
Sternberk
Country [24] 0 0
Czech Republic
State/province [24] 0 0
Usti nad Orlici
Country [25] 0 0
Denmark
State/province [25] 0 0
Roskilde
Country [26] 0 0
Denmark
State/province [26] 0 0
Viborg
Country [27] 0 0
Denmark
State/province [27] 0 0
Ã…rhus
Country [28] 0 0
Estonia
State/province [28] 0 0
Tallinn
Country [29] 0 0
France
State/province [29] 0 0
Annonay
Country [30] 0 0
France
State/province [30] 0 0
Creil
Country [31] 0 0
France
State/province [31] 0 0
Grenoble
Country [32] 0 0
France
State/province [32] 0 0
Metz
Country [33] 0 0
France
State/province [33] 0 0
Montivilliers
Country [34] 0 0
France
State/province [34] 0 0
Nice
Country [35] 0 0
France
State/province [35] 0 0
Poissy
Country [36] 0 0
France
State/province [36] 0 0
Reims Cedex
Country [37] 0 0
France
State/province [37] 0 0
Rouen Cedex
Country [38] 0 0
France
State/province [38] 0 0
Saint Priest en Jarez
Country [39] 0 0
Germany
State/province [39] 0 0
Bernkastel-Kues
Country [40] 0 0
Germany
State/province [40] 0 0
Coesfeld
Country [41] 0 0
Germany
State/province [41] 0 0
Düsseldorf
Country [42] 0 0
Germany
State/province [42] 0 0
Hamburg
Country [43] 0 0
Germany
State/province [43] 0 0
Leverkusen
Country [44] 0 0
Greece
State/province [44] 0 0
Alexandroupoli
Country [45] 0 0
Greece
State/province [45] 0 0
Athens
Country [46] 0 0
Greece
State/province [46] 0 0
Larissa
Country [47] 0 0
Greece
State/province [47] 0 0
Thessaloniki
Country [48] 0 0
Hungary
State/province [48] 0 0
Baja
Country [49] 0 0
Hungary
State/province [49] 0 0
Budapest
Country [50] 0 0
Hungary
State/province [50] 0 0
Debrecen
Country [51] 0 0
Hungary
State/province [51] 0 0
Esztergom
Country [52] 0 0
Hungary
State/province [52] 0 0
Gyor
Country [53] 0 0
Hungary
State/province [53] 0 0
Kaposvar
Country [54] 0 0
Hungary
State/province [54] 0 0
Pecs
Country [55] 0 0
Hungary
State/province [55] 0 0
Szekszard
Country [56] 0 0
Hungary
State/province [56] 0 0
Szombathely
Country [57] 0 0
Hungary
State/province [57] 0 0
Zalaegerszeg
Country [58] 0 0
Israel
State/province [58] 0 0
Ashkelon
Country [59] 0 0
Israel
State/province [59] 0 0
Hadera
Country [60] 0 0
Israel
State/province [60] 0 0
Jerusalem
Country [61] 0 0
Italy
State/province [61] 0 0
Albano Laziale RM
Country [62] 0 0
Italy
State/province [62] 0 0
Ancona
Country [63] 0 0
Italy
State/province [63] 0 0
Cagliari
Country [64] 0 0
Italy
State/province [64] 0 0
Firenze
Country [65] 0 0
Italy
State/province [65] 0 0
Lecco
Country [66] 0 0
Italy
State/province [66] 0 0
Napoli
Country [67] 0 0
Italy
State/province [67] 0 0
Pavia
Country [68] 0 0
Italy
State/province [68] 0 0
Roma
Country [69] 0 0
Italy
State/province [69] 0 0
Torino
Country [70] 0 0
Latvia
State/province [70] 0 0
Daugavpils
Country [71] 0 0
Latvia
State/province [71] 0 0
Riga
Country [72] 0 0
Latvia
State/province [72] 0 0
Valmiera
Country [73] 0 0
Latvia
State/province [73] 0 0
Ventspils
Country [74] 0 0
Mexico
State/province [74] 0 0
Coahuila
Country [75] 0 0
Mexico
State/province [75] 0 0
Jalisco
Country [76] 0 0
Mexico
State/province [76] 0 0
Morelos
Country [77] 0 0
Mexico
State/province [77] 0 0
Querétaro
Country [78] 0 0
Mexico
State/province [78] 0 0
San Luis PotosÃ-
Country [79] 0 0
Poland
State/province [79] 0 0
Choszczno
Country [80] 0 0
Poland
State/province [80] 0 0
Golub-Dobrzyn
Country [81] 0 0
Poland
State/province [81] 0 0
Koscierzyna
Country [82] 0 0
Poland
State/province [82] 0 0
Koszalin
Country [83] 0 0
Poland
State/province [83] 0 0
Legnica
Country [84] 0 0
Poland
State/province [84] 0 0
Lodz
Country [85] 0 0
Poland
State/province [85] 0 0
Lublin
Country [86] 0 0
Poland
State/province [86] 0 0
Poznan
Country [87] 0 0
Poland
State/province [87] 0 0
Warszawa
Country [88] 0 0
Poland
State/province [88] 0 0
Zamosc
Country [89] 0 0
Portugal
State/province [89] 0 0
Evora
Country [90] 0 0
Portugal
State/province [90] 0 0
Faro
Country [91] 0 0
Portugal
State/province [91] 0 0
Lisboa
Country [92] 0 0
Portugal
State/province [92] 0 0
Porto
Country [93] 0 0
Portugal
State/province [93] 0 0
Setúbal
Country [94] 0 0
Romania
State/province [94] 0 0
Bucharest
Country [95] 0 0
Romania
State/province [95] 0 0
Iasi
Country [96] 0 0
Romania
State/province [96] 0 0
Timisoara
Country [97] 0 0
Russian Federation
State/province [97] 0 0
Ekaterinburg
Country [98] 0 0
Russian Federation
State/province [98] 0 0
Moscow
Country [99] 0 0
Russian Federation
State/province [99] 0 0
Saint Petersburg
Country [100] 0 0
Russian Federation
State/province [100] 0 0
Saint-Petersburg
Country [101] 0 0
Serbia
State/province [101] 0 0
Belgrade
Country [102] 0 0
Serbia
State/province [102] 0 0
Krgujevac
Country [103] 0 0
Serbia
State/province [103] 0 0
Zemun
Country [104] 0 0
Slovakia
State/province [104] 0 0
Bratislava
Country [105] 0 0
Slovakia
State/province [105] 0 0
Galanta
Country [106] 0 0
Slovakia
State/province [106] 0 0
Namestovo
Country [107] 0 0
Slovakia
State/province [107] 0 0
Sala
Country [108] 0 0
Slovakia
State/province [108] 0 0
Trstena
Country [109] 0 0
Slovakia
State/province [109] 0 0
Zvolen
Country [110] 0 0
Slovenia
State/province [110] 0 0
Jesenice
Country [111] 0 0
Slovenia
State/province [111] 0 0
Novo mesto
Country [112] 0 0
Slovenia
State/province [112] 0 0
Sempeter pri Gorici
Country [113] 0 0
Slovenia
State/province [113] 0 0
Slovenj Gradec
Country [114] 0 0
Spain
State/province [114] 0 0
AndalucÃ-a
Country [115] 0 0
Spain
State/province [115] 0 0
Cataluña
Country [116] 0 0
Spain
State/province [116] 0 0
Madrid
Country [117] 0 0
Spain
State/province [117] 0 0
PaÃ-s Vasco
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Birmingham
Country [119] 0 0
United Kingdom
State/province [119] 0 0
Brighton
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Cambridge
Country [121] 0 0
United Kingdom
State/province [121] 0 0
Coventry
Country [122] 0 0
United Kingdom
State/province [122] 0 0
Glasgow
Country [123] 0 0
United Kingdom
State/province [123] 0 0
Hull
Country [124] 0 0
United Kingdom
State/province [124] 0 0
Leicester
Country [125] 0 0
United Kingdom
State/province [125] 0 0
Newcastle Upon Tyne
Country [126] 0 0
United Kingdom
State/province [126] 0 0
Salford
Country [127] 0 0
United Kingdom
State/province [127] 0 0
Shrewsbury
Country [128] 0 0
United Kingdom
State/province [128] 0 0
Stevenage
Country [129] 0 0
United Kingdom
State/province [129] 0 0
Stoke On Trent
Country [130] 0 0
United Kingdom
State/province [130] 0 0
Swansea
Country [131] 0 0
United Kingdom
State/province [131] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT00925587
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications