Back to resultsEvaluation of Monthly Darbepoetin Alfa Dosing for Correction of Anemia in Non-dialysis Chronic Kidney Disease
Primary Purpose
Anemia, Chronic Kidney Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
darbepoetin alfa
Sponsored by
About this trial
This is an interventional treatment trial for Anemia focused on measuring CKD, Anemia, correction, darbepoetin alfa
Eligibility Criteria
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%
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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Q2W
QM
Arm Description
Q2W administration of darbepoetin alfa.
QM administration of darbepoetin alfa
Outcomes
Primary Outcome Measures
Hb Change Between Baseline and the Evaluation Period (Average of Weeks 29-33)
The Adjusted Analysis is the primary analysis and includes treatment group and baseline Hb value as covariates. Non-inferiority is concluded if the lower limit of the 95% confidence interval for the mean difference is above -0.5g/dL.
Secondary Outcome Measures
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.
Hb at Baseline
Hb at Week 3
Hb at Week 5
Hb at Week 7
Hb at Week 9
Hb at Week 11
Hb at Week 13
Hb at Week 15
Hb at Week 17
Hb at Week 19
Hb at Week 21
Hb at Week 23
Hb at Week 25
Hb at Week 27
Hb at Week 29
Hb at Week 31
Hb at Week 33
Darbepoetin Alfa Dose at Week 1
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Darbepoetin Alfa Dose at Week 3
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Darbepoetin Alfa Dose at Week 5
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Darbepoetin Alfa Dose at Week 7
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Darbepoetin Alfa Dose at Week 9
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Darbepoetin Alfa Dose at Week 11
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Darbepoetin Alfa Dose at Week 13
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Darbepoetin Alfa Dose at Week 15
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Darbepoetin Alfa Dose at Week 17
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Darbepoetin Alfa Dose at Week 19
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Darbepoetin Alfa Dose at Week 21
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Darbepoetin Alfa Dose at Week 23
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Darbepoetin Alfa Dose at Week 25
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Darbepoetin Alfa Dose at Week 27
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Darbepoetin Alfa Dose at Week 29
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Darbepoetin Alfa Dose at Week 31
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Darbepoetin Alfa Dose During the Evaluation Period (Average of Weeks 29-33)
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Ratio of Darbepoetin Alfa Dose to Baseline at Week 3
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Ratio of Darbepoetin Alfa Dose to Baseline at Week 5
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Ratio of Darbepoetin Alfa Dose to Baseline at Week 7
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Ratio of Darbepoetin Alfa Dose to Baseline at Week 9
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Ratio of Darbepoetin Alfa Dose to Baseline at Week 11
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Ratio of Darbepoetin Alfa Dose to Baseline at Week 13
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Ratio of Darbepoetin Alfa Dose to Baseline at Week 15
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Ratio of Darbepoetin Alfa Dose to Baseline at Week 17
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Ratio of Darbepoetin Alfa Dose to Baseline at Week 19
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Ratio of Darbepoetin Alfa Dose to Baseline at Week 21
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Ratio of Darbepoetin Alfa Dose to Baseline at Week 23
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Ratio of Darbepoetin Alfa Dose to Baseline at Week 25
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Ratio of Darbepoetin Alfa Dose to Baseline at Week 27
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Ratio of Darbepoetin Alfa Dose to Baseline at Week 29
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Ratio of Darbepoetin Alfa Dose to Baseline at Week 31
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Dose of Darbepoetin Alfa at the First Achievement of a Hb ≥10.0 g/dL and a ≥1.0 g/dL Increase From Baseline (Weeks 1-33)
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time to First Achievement of a Hb ≥10.0 g/dL and a ≥1.0 g/dL Increase From Baseline (Weeks 1-33)
Ratio of Darbepoetin Alfa Dose to Baseline at the Evalaution Period (Average of Weeks 29-33)
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00925587
Brief Title
Evaluation of Monthly Darbepoetin Alfa Dosing for Correction of Anemia in Non-dialysis Chronic Kidney Disease
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Chronic Kidney Disease
Keywords
CKD, Anemia, correction, darbepoetin alfa
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
358 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Q2W
Arm Type
Active Comparator
Arm Description
Q2W administration of darbepoetin alfa.
Arm Title
QM
Arm Type
Active Comparator
Arm Description
QM administration of darbepoetin alfa
Intervention Type
Drug
Intervention Name(s)
darbepoetin alfa
Other Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hb Change Between Baseline and the Evaluation Period (Average of Weeks 29-33)
Description
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.
Time Frame
Baseline Week 33
Secondary Outcome Measure Information:
Title
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.
Time Frame
Baseline to Week 33
Title
Hb at Baseline
Time Frame
Baseline
Title
Hb at Week 3
Time Frame
Week 3
Title
Hb at Week 5
Time Frame
Week 5
Title
Hb at Week 7
Time Frame
Week 7
Title
Hb at Week 9
Time Frame
Week 9
Title
Hb at Week 11
Time Frame
Week 11
Title
Hb at Week 13
Time Frame
Week 13
Title
Hb at Week 15
Time Frame
Week 15
Title
Hb at Week 17
Time Frame
Week 17
Title
Hb at Week 19
Time Frame
Week 19
Title
Hb at Week 21
Time Frame
Week 21
Title
Hb at Week 23
Time Frame
Week 23
Title
Hb at Week 25
Time Frame
Week 25
Title
Hb at Week 27
Time Frame
Week 27
Title
Hb at Week 29
Time Frame
Week 29
Title
Hb at Week 31
Time Frame
Week 31
Title
Hb at Week 33
Time Frame
Week 33
Title
Darbepoetin Alfa Dose at Week 1
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Week 1
Title
Darbepoetin Alfa Dose at Week 3
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Week 3
Title
Darbepoetin Alfa Dose at Week 5
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Week 5
Title
Darbepoetin Alfa Dose at Week 7
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Week 7
Title
Darbepoetin Alfa Dose at Week 9
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Week 9
Title
Darbepoetin Alfa Dose at Week 11
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Week 11
Title
Darbepoetin Alfa Dose at Week 13
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Week 13
Title
Darbepoetin Alfa Dose at Week 15
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Week 15
Title
Darbepoetin Alfa Dose at Week 17
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Week 17
Title
Darbepoetin Alfa Dose at Week 19
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Week 19
Title
Darbepoetin Alfa Dose at Week 21
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Week 21
Title
Darbepoetin Alfa Dose at Week 23
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Week 23
Title
Darbepoetin Alfa Dose at Week 25
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Week 25
Title
Darbepoetin Alfa Dose at Week 27
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Week 27
Title
Darbepoetin Alfa Dose at Week 29
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Week 29
Title
Darbepoetin Alfa Dose at Week 31
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Week 31
Title
Darbepoetin Alfa Dose During the Evaluation Period (Average of Weeks 29-33)
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Weeks 29-33
Title
Ratio of Darbepoetin Alfa Dose to Baseline at Week 3
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Week 3
Title
Ratio of Darbepoetin Alfa Dose to Baseline at Week 5
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Week 5
Title
Ratio of Darbepoetin Alfa Dose to Baseline at Week 7
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Week 7
Title
Ratio of Darbepoetin Alfa Dose to Baseline at Week 9
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Week 9
Title
Ratio of Darbepoetin Alfa Dose to Baseline at Week 11
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Week 11
Title
Ratio of Darbepoetin Alfa Dose to Baseline at Week 13
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Week 13
Title
Ratio of Darbepoetin Alfa Dose to Baseline at Week 15
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Week 15
Title
Ratio of Darbepoetin Alfa Dose to Baseline at Week 17
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Week 17
Title
Ratio of Darbepoetin Alfa Dose to Baseline at Week 19
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Week 19
Title
Ratio of Darbepoetin Alfa Dose to Baseline at Week 21
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Week 21
Title
Ratio of Darbepoetin Alfa Dose to Baseline at Week 23
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Week 23
Title
Ratio of Darbepoetin Alfa Dose to Baseline at Week 25
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Week 25
Title
Ratio of Darbepoetin Alfa Dose to Baseline at Week 27
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Week 27
Title
Ratio of Darbepoetin Alfa Dose to Baseline at Week 29
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Week 29
Title
Ratio of Darbepoetin Alfa Dose to Baseline at Week 31
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Week 31
Title
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)
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Weeks 1-33
Title
Time to First Achievement of a Hb ≥10.0 g/dL and a ≥1.0 g/dL Increase From Baseline (Weeks 1-33)
Time Frame
Weeks 1-33
Title
Ratio of Darbepoetin Alfa Dose to Baseline at the Evalaution Period (Average of Weeks 29-33)
Description
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Time Frame
Evaluation Period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Facility Name
Research Site
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Research Site
City
New Lambton
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Research Site
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Research Site
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4870
Country
Australia
Facility Name
Research Site
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Research Site
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
Facility Name
Research Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Research Site
City
Reservoir
State/Province
Victoria
ZIP/Postal Code
3073
Country
Australia
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Research Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Research Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Research Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Research Site
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Research Site
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1709
Country
Bulgaria
Facility Name
Research Site
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
Research Site
City
Brno
ZIP/Postal Code
615 00
Country
Czech Republic
Facility Name
Research Site
City
Chrudim
ZIP/Postal Code
537 27
Country
Czech Republic
Facility Name
Research Site
City
Jilemnice
ZIP/Postal Code
514 15
Country
Czech Republic
Facility Name
Research Site
City
Kladno
ZIP/Postal Code
272 59
Country
Czech Republic
Facility Name
Research Site
City
Liberec 1
ZIP/Postal Code
460 03
Country
Czech Republic
Facility Name
Research Site
City
Novy Jicin
ZIP/Postal Code
741 01
Country
Czech Republic
Facility Name
Research Site
City
Plzen
ZIP/Postal Code
301 00
Country
Czech Republic
Facility Name
Research Site
City
Praha 10
ZIP/Postal Code
100 34
Country
Czech Republic
Facility Name
Research Site
City
Praha 4 - Nusle
ZIP/Postal Code
140 00
Country
Czech Republic
Facility Name
Research Site
City
Praha 4
ZIP/Postal Code
149 00
Country
Czech Republic
Facility Name
Research Site
City
Praha 6
ZIP/Postal Code
160 00
Country
Czech Republic
Facility Name
Research Site
City
Praha 6
ZIP/Postal Code
169 00
Country
Czech Republic
Facility Name
Research Site
City
Praha 8
ZIP/Postal Code
181 02
Country
Czech Republic
Facility Name
Research Site
City
Slavkov u Brna
ZIP/Postal Code
684 01
Country
Czech Republic
Facility Name
Research Site
City
Sternberk
ZIP/Postal Code
785 01
Country
Czech Republic
Facility Name
Research Site
City
Usti nad Orlici
ZIP/Postal Code
562 18
Country
Czech Republic
Facility Name
Research Site
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Research Site
City
Viborg
ZIP/Postal Code
8800
Country
Denmark
Facility Name
Research Site
City
Ã…rhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Research Site
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Research Site
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Research Site
City
Annonay
ZIP/Postal Code
07100
Country
France
Facility Name
Research Site
City
Creil
ZIP/Postal Code
60100
Country
France
Facility Name
Research Site
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
Research Site
City
Metz
ZIP/Postal Code
57000
Country
France
Facility Name
Research Site
City
Montivilliers
ZIP/Postal Code
76290
Country
France
Facility Name
Research Site
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
Research Site
City
Poissy
ZIP/Postal Code
78300
Country
France
Facility Name
Research Site
City
Reims Cedex
ZIP/Postal Code
51092
Country
France
Facility Name
Research Site
City
Rouen Cedex
ZIP/Postal Code
76031
Country
France
Facility Name
Research Site
City
Saint Priest en Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Research Site
City
Bernkastel-Kues
ZIP/Postal Code
54470
Country
Germany
Facility Name
Research Site
City
Coesfeld
ZIP/Postal Code
48653
Country
Germany
Facility Name
Research Site
City
Düsseldorf
ZIP/Postal Code
40210
Country
Germany
Facility Name
Research Site
City
Hamburg
ZIP/Postal Code
22297
Country
Germany
Facility Name
Research Site
City
Leverkusen
ZIP/Postal Code
51373
Country
Germany
Facility Name
Research Site
City
Alexandroupoli
ZIP/Postal Code
68100
Country
Greece
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
Research Site
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
Research Site
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Facility Name
Research Site
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Facility Name
Research Site
City
Baja
ZIP/Postal Code
6500
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
Facility Name
Research Site
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
Facility Name
Research Site
City
Esztergom
ZIP/Postal Code
2500
Country
Hungary
Facility Name
Research Site
City
Gyor
ZIP/Postal Code
9023
Country
Hungary
Facility Name
Research Site
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Research Site
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Research Site
City
Szekszard
ZIP/Postal Code
7100
Country
Hungary
Facility Name
Research Site
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Research Site
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Research Site
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Research Site
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Name
Research Site
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Research Site
City
Albano Laziale RM
ZIP/Postal Code
00041
Country
Italy
Facility Name
Research Site
City
Ancona
ZIP/Postal Code
60125
Country
Italy
Facility Name
Research Site
City
Cagliari
ZIP/Postal Code
09134
Country
Italy
Facility Name
Research Site
City
Firenze
ZIP/Postal Code
50141
Country
Italy
Facility Name
Research Site
City
Lecco
ZIP/Postal Code
23900
Country
Italy
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Research Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
Research Site
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Research Site
City
Torino
ZIP/Postal Code
10154
Country
Italy
Facility Name
Research Site
City
Daugavpils
ZIP/Postal Code
5417
Country
Latvia
Facility Name
Research Site
City
Riga
ZIP/Postal Code
1001
Country
Latvia
Facility Name
Research Site
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Research Site
City
Riga
ZIP/Postal Code
1038
Country
Latvia
Facility Name
Research Site
City
Valmiera
ZIP/Postal Code
4201
Country
Latvia
Facility Name
Research Site
City
Ventspils
ZIP/Postal Code
3600
Country
Latvia
Facility Name
Research Site
City
Saltillo
State/Province
Coahuila
ZIP/Postal Code
25230
Country
Mexico
Facility Name
Research Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44140
Country
Mexico
Facility Name
Research Site
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62448
Country
Mexico
Facility Name
Research Site
City
Queretaro
State/Province
Querétaro
ZIP/Postal Code
76178
Country
Mexico
Facility Name
Research Site
City
San Luis Potosi
State/Province
San Luis PotosÃ-
ZIP/Postal Code
78240
Country
Mexico
Facility Name
Research Site
City
Choszczno
ZIP/Postal Code
73-200
Country
Poland
Facility Name
Research Site
City
Golub-Dobrzyn
ZIP/Postal Code
87-400
Country
Poland
Facility Name
Research Site
City
Koscierzyna
ZIP/Postal Code
83-400
Country
Poland
Facility Name
Research Site
City
Koszalin
ZIP/Postal Code
75-581
Country
Poland
Facility Name
Research Site
City
Legnica
ZIP/Postal Code
59-220
Country
Poland
Facility Name
Research Site
City
Lodz
ZIP/Postal Code
90-549
Country
Poland
Facility Name
Research Site
City
Lodz
ZIP/Postal Code
93-120
Country
Poland
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
61-289
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
04-749
Country
Poland
Facility Name
Research Site
City
Zamosc
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Research Site
City
Evora
ZIP/Postal Code
7000-811
Country
Portugal
Facility Name
Research Site
City
Faro
ZIP/Postal Code
8000-386
Country
Portugal
Facility Name
Research Site
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Research Site
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Research Site
City
Setúbal
ZIP/Postal Code
2910-446
Country
Portugal
Facility Name
Research Site
City
Bucharest
ZIP/Postal Code
010731
Country
Romania
Facility Name
Research Site
City
Bucharest
ZIP/Postal Code
014461
Country
Romania
Facility Name
Research Site
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Research Site
City
Bucharest
ZIP/Postal Code
050098
Country
Romania
Facility Name
Research Site
City
Iasi
ZIP/Postal Code
700503
Country
Romania
Facility Name
Research Site
City
Timisoara
ZIP/Postal Code
300736
Country
Romania
Facility Name
Research Site
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
117036
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
123183
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
191104
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
196247
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
Research Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Research Site
City
Krgujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Research Site
City
Zemun
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Research Site
City
Bratislava
ZIP/Postal Code
831 03
Country
Slovakia
Facility Name
Research Site
City
Galanta
ZIP/Postal Code
924 22
Country
Slovakia
Facility Name
Research Site
City
Namestovo
ZIP/Postal Code
029 01
Country
Slovakia
Facility Name
Research Site
City
Sala
ZIP/Postal Code
927 19
Country
Slovakia
Facility Name
Research Site
City
Trstena
ZIP/Postal Code
028 01
Country
Slovakia
Facility Name
Research Site
City
Zvolen
ZIP/Postal Code
960 01
Country
Slovakia
Facility Name
Research Site
City
Jesenice
ZIP/Postal Code
4270
Country
Slovenia
Facility Name
Research Site
City
Novo mesto
ZIP/Postal Code
8000
Country
Slovenia
Facility Name
Research Site
City
Sempeter pri Gorici
ZIP/Postal Code
5290
Country
Slovenia
Facility Name
Research Site
City
Slovenj Gradec
ZIP/Postal Code
2380
Country
Slovenia
Facility Name
Research Site
City
Jaén
State/Province
AndalucÃ-a
ZIP/Postal Code
23007
Country
Spain
Facility Name
Research Site
City
Barcelona
State/Province
Cataluña
ZIP/Postal Code
08036
Country
Spain
Facility Name
Research Site
City
L'Hospitalet de Llobregat
State/Province
Cataluña
ZIP/Postal Code
08907
Country
Spain
Facility Name
Research Site
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Research Site
City
Galdakao
State/Province
PaÃ-s Vasco
ZIP/Postal Code
48960
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Research Site
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Research Site
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Research Site
City
Cambridge
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Research Site
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Research Site
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
Research Site
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Research Site
City
Leicester
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Facility Name
Research Site
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Research Site
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Research Site
City
Shrewsbury
ZIP/Postal Code
SY3 8XQ
Country
United Kingdom
Facility Name
Research Site
City
Stevenage
ZIP/Postal Code
SG1 4AB
Country
United Kingdom
Facility Name
Research Site
City
Stoke On Trent
ZIP/Postal Code
ST4 7LN
Country
United Kingdom
Facility Name
Research Site
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom
Facility Name
Research Site
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
24506498
Citation
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.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Evaluation of Monthly Darbepoetin Alfa Dosing for Correction of Anemia in Non-dialysis Chronic Kidney Disease
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