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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
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Belgium
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Edegem
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Belgium
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Gent
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Belgium
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Leuven
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Belgium
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Liège
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Roeselare
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Sofia
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Bulgaria
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Varna
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Czech Republic
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Brno
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Czech Republic
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Madrid
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PaÃ-s Vasco
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Brighton
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Coventry
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Glasgow
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Hull
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Leicester
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Newcastle Upon Tyne
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Salford
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Shrewsbury
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Stevenage
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Stoke On Trent
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Swansea
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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/study/NCT00925587
Trial related presentations / publications
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.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00925587