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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00925587
Ethics application status
Date submitted
28/05/2009
Date registered
22/06/2009
Date last updated
4/06/2014

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
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Blood 0 0 0 0
Anaemia

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)
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
Timepoint [19] 0 0
Week 1
Secondary outcome [20] 0 0
Darbepoetin Alfa Dose at Week 3
Timepoint [20] 0 0
Week 3
Secondary outcome [21] 0 0
Darbepoetin Alfa Dose at Week 5
Timepoint [21] 0 0
Week 5
Secondary outcome [22] 0 0
Darbepoetin Alfa Dose at Week 7
Timepoint [22] 0 0
Week 7
Secondary outcome [23] 0 0
Darbepoetin Alfa Dose at Week 9
Timepoint [23] 0 0
Week 9
Secondary outcome [24] 0 0
Darbepoetin Alfa Dose at Week 11
Timepoint [24] 0 0
Week 11
Secondary outcome [25] 0 0
Darbepoetin Alfa Dose at Week 13
Timepoint [25] 0 0
Week 13
Secondary outcome [26] 0 0
Darbepoetin Alfa Dose at Week 15
Timepoint [26] 0 0
Week 15
Secondary outcome [27] 0 0
Darbepoetin Alfa Dose at Week 17
Timepoint [27] 0 0
Week 17
Secondary outcome [28] 0 0
Darbepoetin Alfa Dose at Week 19
Timepoint [28] 0 0
Week 19
Secondary outcome [29] 0 0
Darbepoetin Alfa Dose at Week 21
Timepoint [29] 0 0
Week 21
Secondary outcome [30] 0 0
Darbepoetin Alfa Dose at Week 23
Timepoint [30] 0 0
Week 23
Secondary outcome [31] 0 0
Darbepoetin Alfa Dose at Week 25
Timepoint [31] 0 0
Week 25
Secondary outcome [32] 0 0
Darbepoetin Alfa Dose at Week 27
Timepoint [32] 0 0
Week 27
Secondary outcome [33] 0 0
Darbepoetin Alfa Dose at Week 29
Timepoint [33] 0 0
Week 29
Secondary outcome [34] 0 0
Darbepoetin Alfa Dose at Week 31
Timepoint [34] 0 0
Week 31
Secondary outcome [35] 0 0
Darbepoetin Alfa Dose During the Evaluation Period (Average of Weeks 29-33)
Timepoint [35] 0 0
Weeks 29-33
Secondary outcome [36] 0 0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 3
Timepoint [36] 0 0
Week 3
Secondary outcome [37] 0 0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 5
Timepoint [37] 0 0
Week 5
Secondary outcome [38] 0 0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 7
Timepoint [38] 0 0
Week 7
Secondary outcome [39] 0 0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 9
Timepoint [39] 0 0
Week 9
Secondary outcome [40] 0 0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 11
Timepoint [40] 0 0
Week 11
Secondary outcome [41] 0 0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 13
Timepoint [41] 0 0
Week 13
Secondary outcome [42] 0 0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 15
Timepoint [42] 0 0
Week 15
Secondary outcome [43] 0 0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 17
Timepoint [43] 0 0
Week 17
Secondary outcome [44] 0 0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 19
Timepoint [44] 0 0
Week 19
Secondary outcome [45] 0 0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 21
Timepoint [45] 0 0
Week 21
Secondary outcome [46] 0 0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 23
Timepoint [46] 0 0
Week 23
Secondary outcome [47] 0 0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 25
Timepoint [47] 0 0
Week 25
Secondary outcome [48] 0 0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 27
Timepoint [48] 0 0
Week 27
Secondary outcome [49] 0 0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 29
Timepoint [49] 0 0
Week 29
Secondary outcome [50] 0 0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 31
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)
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)
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
Sex
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
1/06/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2012
Sample size
Target
Accrual to date
Final
358
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
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Germany
State/province [39] 0 0
Bernkastel-Kues
Country [40] 0 0
Germany
State/province [40] 0 0
Coesfeld
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Germany
State/province [41] 0 0
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State/province [42] 0 0
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Hungary
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Gyor
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Hungary
State/province [53] 0 0
Kaposvar
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Hungary
State/province [54] 0 0
Pecs
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Hungary
State/province [55] 0 0
Szekszard
Country [56] 0 0
Hungary
State/province [56] 0 0
Szombathely
Country [57] 0 0
Hungary
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Country [58] 0 0
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State/province [58] 0 0
Ashkelon
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Israel
State/province [59] 0 0
Hadera
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State/province [60] 0 0
Jerusalem
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Albano Laziale RM
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Ancona
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Cagliari
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Firenze
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Lecco
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Napoli
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State/province [67] 0 0
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Koscierzyna
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Warszawa
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Zamosc
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Evora
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Portugal
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Faro
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Portugal
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Lisboa
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Portugal
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Porto
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Portugal
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Setúbal
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Romania
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Bucharest
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Romania
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Iasi
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Romania
State/province [96] 0 0
Timisoara
Country [97] 0 0
Russian Federation
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Ekaterinburg
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Russian Federation
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Moscow
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Russian Federation
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Saint Petersburg
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Belgrade
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Krgujevac
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Serbia
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Zemun
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Bratislava
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Galanta
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Namestovo
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Sala
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Slovakia
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Trstena
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Zvolen
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Jesenice
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Slovenia
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Sempeter pri Gorici
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Slovenia
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Slovenj Gradec
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Spain
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AndalucÃ-a
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Spain
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Cataluña
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Spain
State/province [116] 0 0
Madrid
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Spain
State/province [117] 0 0
PaÃ-s Vasco
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United Kingdom
State/province [118] 0 0
Birmingham
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United Kingdom
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Brighton
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United Kingdom
State/province [120] 0 0
Cambridge
Country [121] 0 0
United Kingdom
State/province [121] 0 0
Coventry
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United Kingdom
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Glasgow
Country [123] 0 0
United Kingdom
State/province [123] 0 0
Hull
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United Kingdom
State/province [124] 0 0
Leicester
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United Kingdom
State/province [125] 0 0
Newcastle Upon Tyne
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United Kingdom
State/province [126] 0 0
Salford
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United Kingdom
State/province [127] 0 0
Shrewsbury
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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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00925587