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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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0
2006-003173-27
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Secondary ID [2]
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20060163
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Anemia
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0
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Chronic Kidney Disease
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Condition category
Condition code
Renal and Urogenital
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0
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Kidney disease
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Renal and Urogenital
0
0
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0
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Other renal and urogenital disorders
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Blood
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0
0
0
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Anaemia
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Hb Change Between Baseline and the Evaluation Period (Average of Weeks 29-33)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline Week 33
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Secondary outcome [1]
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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.
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Assessment method [1]
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Timepoint [1]
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Baseline to Week 33
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Secondary outcome [2]
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Hb at Baseline
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Assessment method [2]
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Timepoint [2]
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Baseline
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Secondary outcome [3]
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Hb at Week 3
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Assessment method [3]
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Timepoint [3]
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Week 3
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Secondary outcome [4]
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Hb at Week 5
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Assessment method [4]
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0
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Timepoint [4]
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0
Week 5
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Secondary outcome [5]
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Hb at Week 7
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Assessment method [5]
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0
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Timepoint [5]
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0
Week 7
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Secondary outcome [6]
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Hb at Week 9
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Assessment method [6]
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0
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Timepoint [6]
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0
Week 9
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Secondary outcome [7]
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Hb at Week 11
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Assessment method [7]
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0
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Timepoint [7]
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Week 11
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Secondary outcome [8]
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Hb at Week 13
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Assessment method [8]
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0
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Timepoint [8]
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Week 13
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Secondary outcome [9]
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Hb at Week 15
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Assessment method [9]
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0
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Timepoint [9]
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Week 15
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Secondary outcome [10]
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Hb at Week 17
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Assessment method [10]
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0
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Timepoint [10]
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0
Week 17
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Secondary outcome [11]
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Hb at Week 19
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Assessment method [11]
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0
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Timepoint [11]
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Week 19
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Secondary outcome [12]
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Hb at Week 21
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Assessment method [12]
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0
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Timepoint [12]
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0
Week 21
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Secondary outcome [13]
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Hb at Week 23
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Assessment method [13]
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0
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Timepoint [13]
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Week 23
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Secondary outcome [14]
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Hb at Week 25
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Assessment method [14]
0
0
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Timepoint [14]
0
0
Week 25
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Secondary outcome [15]
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0
Hb at Week 27
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Assessment method [15]
0
0
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Timepoint [15]
0
0
Week 27
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Secondary outcome [16]
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0
Hb at Week 29
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Assessment method [16]
0
0
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Timepoint [16]
0
0
Week 29
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Secondary outcome [17]
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0
Hb at Week 31
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Assessment method [17]
0
0
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Timepoint [17]
0
0
Week 31
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Secondary outcome [18]
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0
Hb at Week 33
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Assessment method [18]
0
0
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Timepoint [18]
0
0
Week 33
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Secondary outcome [19]
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0
Darbepoetin Alfa Dose at Week 1
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Assessment method [19]
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Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [19]
0
0
Week 1
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Secondary outcome [20]
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Darbepoetin Alfa Dose at Week 3
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Assessment method [20]
0
0
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [20]
0
0
Week 3
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Secondary outcome [21]
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Darbepoetin Alfa Dose at Week 5
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Assessment method [21]
0
0
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [21]
0
0
Week 5
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Secondary outcome [22]
0
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Darbepoetin Alfa Dose at Week 7
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Assessment method [22]
0
0
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [22]
0
0
Week 7
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Secondary outcome [23]
0
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Darbepoetin Alfa Dose at Week 9
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Assessment method [23]
0
0
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [23]
0
0
Week 9
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Secondary outcome [24]
0
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Darbepoetin Alfa Dose at Week 11
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Assessment method [24]
0
0
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [24]
0
0
Week 11
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Secondary outcome [25]
0
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Darbepoetin Alfa Dose at Week 13
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Assessment method [25]
0
0
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [25]
0
0
Week 13
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Secondary outcome [26]
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Darbepoetin Alfa Dose at Week 15
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Assessment method [26]
0
0
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [26]
0
0
Week 15
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Secondary outcome [27]
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Darbepoetin Alfa Dose at Week 17
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Assessment method [27]
0
0
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [27]
0
0
Week 17
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Secondary outcome [28]
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0
Darbepoetin Alfa Dose at Week 19
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Assessment method [28]
0
0
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [28]
0
0
Week 19
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Secondary outcome [29]
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0
Darbepoetin Alfa Dose at Week 21
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Assessment method [29]
0
0
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [29]
0
0
Week 21
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Secondary outcome [30]
0
0
Darbepoetin Alfa Dose at Week 23
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Assessment method [30]
0
0
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [30]
0
0
Week 23
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Secondary outcome [31]
0
0
Darbepoetin Alfa Dose at Week 25
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Assessment method [31]
0
0
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [31]
0
0
Week 25
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Secondary outcome [32]
0
0
Darbepoetin Alfa Dose at Week 27
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Assessment method [32]
0
0
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [32]
0
0
Week 27
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Secondary outcome [33]
0
0
Darbepoetin Alfa Dose at Week 29
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Assessment method [33]
0
0
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [33]
0
0
Week 29
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Secondary outcome [34]
0
0
Darbepoetin Alfa Dose at Week 31
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Assessment method [34]
0
0
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [34]
0
0
Week 31
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Secondary outcome [35]
0
0
Darbepoetin Alfa Dose During the Evaluation Period (Average of Weeks 29-33)
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Assessment method [35]
0
0
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [35]
0
0
Weeks 29-33
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Secondary outcome [36]
0
0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 3
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Assessment method [36]
0
0
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [36]
0
0
Week 3
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Secondary outcome [37]
0
0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 5
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Assessment method [37]
0
0
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [37]
0
0
Week 5
Query!
Secondary outcome [38]
0
0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 7
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Assessment method [38]
0
0
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [38]
0
0
Week 7
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Secondary outcome [39]
0
0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 9
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Assessment method [39]
0
0
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [39]
0
0
Week 9
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Secondary outcome [40]
0
0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 11
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Assessment method [40]
0
0
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [40]
0
0
Week 11
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Secondary outcome [41]
0
0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 13
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Assessment method [41]
0
0
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [41]
0
0
Week 13
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Secondary outcome [42]
0
0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 15
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Assessment method [42]
0
0
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [42]
0
0
Week 15
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Secondary outcome [43]
0
0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 17
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Assessment method [43]
0
0
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [43]
0
0
Week 17
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Secondary outcome [44]
0
0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 19
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Assessment method [44]
0
0
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [44]
0
0
Week 19
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Secondary outcome [45]
0
0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 21
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Assessment method [45]
0
0
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [45]
0
0
Week 21
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Secondary outcome [46]
0
0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 23
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Assessment method [46]
0
0
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [46]
0
0
Week 23
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Secondary outcome [47]
0
0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 25
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Assessment method [47]
0
0
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [47]
0
0
Week 25
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Secondary outcome [48]
0
0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 27
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Assessment method [48]
0
0
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [48]
0
0
Week 27
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Secondary outcome [49]
0
0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 29
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Assessment method [49]
0
0
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [49]
0
0
Week 29
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Secondary outcome [50]
0
0
Ratio of Darbepoetin Alfa Dose to Baseline at Week 31
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Assessment method [50]
0
0
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [50]
0
0
Week 31
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Secondary outcome [51]
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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)
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Assessment method [51]
0
0
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [51]
0
0
Weeks 1-33
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Secondary outcome [52]
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0
Time to First Achievement of a Hb =10.0 g/dL and a =1.0 g/dL Increase From Baseline (Weeks 1-33)
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Assessment method [52]
0
0
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Timepoint [52]
0
0
Weeks 1-33
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Secondary outcome [53]
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0
Ratio of Darbepoetin Alfa Dose to Baseline at the Evalaution Period (Average of Weeks 29-33)
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Assessment method [53]
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Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
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Timepoint [53]
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Evaluation Period
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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%
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2012
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Sample size
Target
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Accrual to date
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Final
358
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Research Site - Gosford
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Recruitment hospital [2]
0
0
Research Site - Liverpool
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Recruitment hospital [3]
0
0
Research Site - New Lambton
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Recruitment hospital [4]
0
0
Research Site - Randwick
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Recruitment hospital [5]
0
0
Research Site - Cairns
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Recruitment hospital [6]
0
0
Research Site - Box Hill
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Recruitment hospital [7]
0
0
Research Site - Footscray
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Recruitment hospital [8]
0
0
Research Site - Parkville
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Recruitment hospital [9]
0
0
Research Site - Reservoir
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Recruitment postcode(s) [1]
0
0
2250 - Gosford
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Recruitment postcode(s) [2]
0
0
2170 - Liverpool
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Recruitment postcode(s) [3]
0
0
2305 - New Lambton
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Recruitment postcode(s) [4]
0
0
2031 - Randwick
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Recruitment postcode(s) [5]
0
0
4870 - Cairns
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Recruitment postcode(s) [6]
0
0
3128 - Box Hill
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Recruitment postcode(s) [7]
0
0
3011 - Footscray
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Recruitment postcode(s) [8]
0
0
3050 - Parkville
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Recruitment postcode(s) [9]
0
0
3073 - Reservoir
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Recruitment outside Australia
Country [1]
0
0
Belgium
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State/province [1]
0
0
Bruxelles
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Country [2]
0
0
Belgium
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State/province [2]
0
0
Edegem
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Country [3]
0
0
Belgium
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State/province [3]
0
0
Gent
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Country [4]
0
0
Belgium
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State/province [4]
0
0
Leuven
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Country [5]
0
0
Belgium
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State/province [5]
0
0
Liège
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Country [6]
0
0
Belgium
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State/province [6]
0
0
Roeselare
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Country [7]
0
0
Bulgaria
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State/province [7]
0
0
Pleven
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Country [8]
0
0
Bulgaria
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State/province [8]
0
0
Sofia
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Country [9]
0
0
Bulgaria
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State/province [9]
0
0
Varna
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Country [10]
0
0
Czech Republic
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State/province [10]
0
0
Brno
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Country [11]
0
0
Czech Republic
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State/province [11]
0
0
Chrudim
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Country [12]
0
0
Czech Republic
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State/province [12]
0
0
Jilemnice
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Country [13]
0
0
Czech Republic
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State/province [13]
0
0
Kladno
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Country [14]
0
0
Czech Republic
Query!
State/province [14]
0
0
Liberec 1
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Country [15]
0
0
Czech Republic
Query!
State/province [15]
0
0
Novy Jicin
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Country [16]
0
0
Czech Republic
Query!
State/province [16]
0
0
Plzen
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Country [17]
0
0
Czech Republic
Query!
State/province [17]
0
0
Praha 10
Query!
Country [18]
0
0
Czech Republic
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State/province [18]
0
0
Praha 4 - Nusle
Query!
Country [19]
0
0
Czech Republic
Query!
State/province [19]
0
0
Praha 4
Query!
Country [20]
0
0
Czech Republic
Query!
State/province [20]
0
0
Praha 6
Query!
Country [21]
0
0
Czech Republic
Query!
State/province [21]
0
0
Praha 8
Query!
Country [22]
0
0
Czech Republic
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State/province [22]
0
0
Slavkov u Brna
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Country [23]
0
0
Czech Republic
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State/province [23]
0
0
Sternberk
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Country [24]
0
0
Czech Republic
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State/province [24]
0
0
Usti nad Orlici
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Country [25]
0
0
Denmark
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State/province [25]
0
0
Roskilde
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Country [26]
0
0
Denmark
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State/province [26]
0
0
Viborg
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Country [27]
0
0
Denmark
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State/province [27]
0
0
Ã…rhus
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Country [28]
0
0
Estonia
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State/province [28]
0
0
Tallinn
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Country [29]
0
0
France
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State/province [29]
0
0
Annonay
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Country [30]
0
0
France
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State/province [30]
0
0
Creil
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Country [31]
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France
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Grenoble
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France
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Metz
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France
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Montivilliers
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France
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Nice
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France
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Poissy
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France
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Reims Cedex
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France
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France
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Germany
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Germany
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Alexandroupoli
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Larissa
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Greece
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Thessaloniki
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Hungary
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Baja
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Hungary
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Budapest
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Gyor
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Italy
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Italy
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Ancona
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Italy
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Italy
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Firenze
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Italy
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Lecco
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Italy
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Napoli
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Italy
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Pavia
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Italy
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Roma
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Italy
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Torino
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Latvia
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Riga
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Latvia
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Mexico
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Evora
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Faro
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Porto
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Portugal
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Setúbal
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Timisoara
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Belgrade
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Novo mesto
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Cataluña
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Birmingham
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Cambridge
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Coventry
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Glasgow
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Hull
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Leicester
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Swansea
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Amgen
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00925587
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Contacts
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MD
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Amgen
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00925587
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