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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
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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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0
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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0
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Condition category
Condition code
Renal and Urogenital
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0
0
0
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Kidney disease
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Renal and Urogenital
0
0
0
0
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Other renal and urogenital disorders
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Blood
0
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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0
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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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0
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Timepoint [2]
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0
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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0
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Timepoint [3]
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0
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]
0
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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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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0
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]
0
0
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Timepoint [11]
0
0
Week 19
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Secondary outcome [12]
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0
Hb at Week 21
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Assessment method [12]
0
0
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Timepoint [12]
0
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]
0
0
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Timepoint [13]
0
0
Week 23
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Secondary outcome [14]
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0
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]
0
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]
0
0
Darbepoetin Alfa Dose at Week 1
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Assessment method [19]
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 [19]
0
0
Week 1
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Secondary outcome [20]
0
0
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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0
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
0
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
0
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
0
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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0
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]
0
0
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]
0
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]
0
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
Query!
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
Query!
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
Query!
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
Query!
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
Query!
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
Query!
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]
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)
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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]
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)
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Assessment method [52]
0
0
Query!
Timepoint [52]
0
0
Weeks 1-33
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Secondary outcome [53]
0
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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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 [53]
0
0
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]
0
0
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
Query!
State/province [3]
0
0
Gent
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Country [4]
0
0
Belgium
Query!
State/province [4]
0
0
Leuven
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Country [5]
0
0
Belgium
Query!
State/province [5]
0
0
Liège
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Country [6]
0
0
Belgium
Query!
State/province [6]
0
0
Roeselare
Query!
Country [7]
0
0
Bulgaria
Query!
State/province [7]
0
0
Pleven
Query!
Country [8]
0
0
Bulgaria
Query!
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
Query!
State/province [11]
0
0
Chrudim
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Country [12]
0
0
Czech Republic
Query!
State/province [12]
0
0
Jilemnice
Query!
Country [13]
0
0
Czech Republic
Query!
State/province [13]
0
0
Kladno
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Country [14]
0
0
Czech Republic
Query!
State/province [14]
0
0
Liberec 1
Query!
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
Query!
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
Query!
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
Query!
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
Query!
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]
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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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Address
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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/study/NCT00925587
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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.
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Public notes
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Contacts
Principal investigator
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MD
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Amgen
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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
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