Evaluation of Monthly Darbepoetin Alfa Dosing for Correction of Anemia in Non-dialysis Chronic Kidney Disease

May 15, 2014 updated by: Amgen

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
358

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Gosford, New South Wales, Australia, 2250
        • Research Site
      • Liverpool, New South Wales, Australia, 2170
        • Research Site
      • New Lambton, New South Wales, Australia, 2305
        • Research Site
      • Randwick, New South Wales, Australia, 2031
        • Research Site
    • Queensland
      • Cairns, Queensland, Australia, 4870
        • Research Site
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Research Site
      • Footscray, Victoria, Australia, 3011
        • Research Site
      • Parkville, Victoria, Australia, 3050
        • Research Site
      • Reservoir, Victoria, Australia, 3073
        • Research Site
  • Belgium
      • Bruxelles, Belgium, 1200
        • Research Site
      • Bruxelles, Belgium, 1020
        • Research Site
      • Edegem, Belgium, 2650
        • Research Site
      • Gent, Belgium, 9000
        • Research Site
      • Leuven, Belgium, 3000
        • Research Site
      • Liège, Belgium, 4000
        • Research Site
      • Roeselare, Belgium, 8800
        • Research Site
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Research Site
      • Sofia, Bulgaria, 1431
        • Research Site
      • Sofia, Bulgaria, 1709
        • Research Site
      • Varna, Bulgaria, 9010
        • Research Site
  • Czech Republic
      • Brno, Czech Republic, 615 00
        • Research Site
      • Chrudim, Czech Republic, 537 27
        • Research Site
      • Jilemnice, Czech Republic, 514 15
        • Research Site
      • Kladno, Czech Republic, 272 59
        • Research Site
      • Liberec 1, Czech Republic, 460 03
        • Research Site
      • Novy Jicin, Czech Republic, 741 01
        • Research Site
      • Plzen, Czech Republic, 301 00
        • Research Site
      • Praha 10, Czech Republic, 100 34
        • Research Site
      • Praha 4, Czech Republic, 149 00
        • Research Site
      • Praha 4 - Nusle, Czech Republic, 140 00
        • Research Site
      • Praha 6, Czech Republic, 160 00
        • Research Site
      • Praha 6, Czech Republic, 169 00
        • Research Site
      • Praha 8, Czech Republic, 181 02
        • Research Site
      • Slavkov u Brna, Czech Republic, 684 01
        • Research Site
      • Sternberk, Czech Republic, 785 01
        • Research Site
      • Usti nad Orlici, Czech Republic, 562 18
        • Research Site
  • Denmark
      • Roskilde, Denmark, 4000
        • Research Site
      • Viborg, Denmark, 8800
        • Research Site
      • Ã…rhus, Denmark, 8200
        • Research Site
  • Estonia
      • Tallinn, Estonia, 10617
        • Research Site
      • Tallinn, Estonia, 13419
        • Research Site
  • France
      • Annonay, France, 07100
        • Research Site
      • Creil, France, 60100
        • Research Site
      • Grenoble, France, 38000
        • Research Site
      • Metz, France, 57000
        • Research Site
      • Montivilliers, France, 76290
        • Research Site
      • Nice, France, 06000
        • Research Site
      • Poissy, France, 78300
        • Research Site
      • Reims Cedex, France, 51092
        • Research Site
      • Rouen Cedex, France, 76031
        • Research Site
      • Saint Priest en Jarez, France, 42270
        • Research Site
  • Germany
      • Bernkastel-Kues, Germany, 54470
        • Research Site
      • Coesfeld, Germany, 48653
        • Research Site
      • Düsseldorf, Germany, 40210
        • Research Site
      • Hamburg, Germany, 22297
        • Research Site
      • Leverkusen, Germany, 51373
        • Research Site
  • Greece
      • Alexandroupoli, Greece, 68100
        • Research Site
      • Athens, Greece, 11528
        • Research Site
      • Larissa, Greece, 41110
        • Research Site
      • Thessaloniki, Greece, 54636
        • Research Site
      • Thessaloniki, Greece, 54642
        • Research Site
  • Hungary
      • Baja, Hungary, 6500
        • Research Site
      • Budapest, Hungary, 1115
        • Research Site
      • Debrecen, Hungary, 4012
        • Research Site
      • Esztergom, Hungary, 2500
        • Research Site
      • Gyor, Hungary, 9023
        • Research Site
      • Kaposvar, Hungary, 7400
        • Research Site
      • Pecs, Hungary, 7624
        • Research Site
      • Szekszard, Hungary, 7100
        • Research Site
      • Szombathely, Hungary, 9700
        • Research Site
      • Zalaegerszeg, Hungary, 8900
        • Research Site
  • Israel
      • Ashkelon, Israel, 78278
        • Research Site
      • Hadera, Israel, 38100
        • Research Site
      • Jerusalem, Israel, 91031
        • Research Site
  • Italy
      • Albano Laziale RM, Italy, 00041
        • Research Site
      • Ancona, Italy, 60125
        • Research Site
      • Cagliari, Italy, 09134
        • Research Site
      • Firenze, Italy, 50141
        • Research Site
      • Lecco, Italy, 23900
        • Research Site
      • Napoli, Italy, 80131
        • Research Site
      • Pavia, Italy, 27100
        • Research Site
      • Roma, Italy, 00189
        • Research Site
      • Torino, Italy, 10126
        • Research Site
      • Torino, Italy, 10154
        • Research Site
  • Latvia
      • Daugavpils, Latvia, 5417
        • Research Site
      • Riga, Latvia, 1001
        • Research Site
      • Riga, Latvia, 1002
        • Research Site
      • Riga, Latvia, 1038
        • Research Site
      • Valmiera, Latvia, 4201
        • Research Site
      • Ventspils, Latvia, 3600
        • Research Site
  • Mexico
    • Coahuila
      • Saltillo, Coahuila, Mexico, 25230
        • Research Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44140
        • Research Site
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62448
        • Research Site
    • Querétaro
      • Queretaro, Querétaro, Mexico, 76178
        • Research Site
    • San Luis PotosÃ-
      • San Luis Potosi, San Luis PotosÃ-, Mexico, 78240
        • Research Site
  • Poland
      • Choszczno, Poland, 73-200
        • Research Site
      • Golub-Dobrzyn, Poland, 87-400
        • Research Site
      • Koscierzyna, Poland, 83-400
        • Research Site
      • Koszalin, Poland, 75-581
        • Research Site
      • Legnica, Poland, 59-220
        • Research Site
      • Lodz, Poland, 90-549
        • Research Site
      • Lodz, Poland, 93-120
        • Research Site
      • Lublin, Poland, 20-954
        • Research Site
      • Poznan, Poland, 61-289
        • Research Site
      • Warszawa, Poland, 04-749
        • Research Site
      • Zamosc, Poland, 87-100
        • Research Site
  • Portugal
      • Evora, Portugal, 7000-811
        • Research Site
      • Faro, Portugal, 8000-386
        • Research Site
      • Lisboa, Portugal, 1649-035
        • Research Site
      • Porto, Portugal, 4099-001
        • Research Site
      • Setúbal, Portugal, 2910-446
        • Research Site
  • Romania
      • Bucharest, Romania, 050098
        • Research Site
      • Bucharest, Romania, 022328
        • Research Site
      • Bucharest, Romania, 014461
        • Research Site
      • Bucharest, Romania, 010731
        • Research Site
      • Iasi, Romania, 700503
        • Research Site
      • Timisoara, Romania, 300736
        • Research Site
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620102
        • Research Site
      • Moscow, Russian Federation, 125284
        • Research Site
      • Moscow, Russian Federation, 117036
        • Research Site
      • Moscow, Russian Federation, 123183
        • Research Site
      • Saint Petersburg, Russian Federation, 191104
        • Research Site
      • Saint Petersburg, Russian Federation, 196247
        • Research Site
      • Saint-Petersburg, Russian Federation, 195067
        • Research Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Research Site
      • Krgujevac, Serbia, 34000
        • Research Site
      • Zemun, Serbia, 11080
        • Research Site
  • Slovakia
      • Bratislava, Slovakia, 831 03
        • Research Site
      • Galanta, Slovakia, 924 22
        • Research Site
      • Namestovo, Slovakia, 029 01
        • Research Site
      • Sala, Slovakia, 927 19
        • Research Site
      • Trstena, Slovakia, 028 01
        • Research Site
      • Zvolen, Slovakia, 960 01
        • Research Site
  • Slovenia
      • Jesenice, Slovenia, 4270
        • Research Site
      • Novo mesto, Slovenia, 8000
        • Research Site
      • Sempeter pri Gorici, Slovenia, 5290
        • Research Site
      • Slovenj Gradec, Slovenia, 2380
        • Research Site
  • Spain
      • Madrid, Spain, 28046
        • Research Site
    • AndalucÃ-a
      • Jaén, AndalucÃ-a, Spain, 23007
        • Research Site
    • Cataluña
      • Barcelona, Cataluña, Spain, 08036
        • Research Site
      • L'Hospitalet de Llobregat, Cataluña, Spain, 08907
        • Research Site
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Research Site
    • PaÃ-s Vasco
      • Galdakao, PaÃ-s Vasco, Spain, 48960
        • Research Site
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Research Site
      • Brighton, United Kingdom, BN2 5BE
        • Research Site
      • Cambridge, United Kingdom, CB2 2QQ
        • Research Site
      • Coventry, United Kingdom, CV2 2DX
        • Research Site
      • Glasgow, United Kingdom, G11 6NT
        • Research Site
      • Hull, United Kingdom, HU3 2JZ
        • Research Site
      • Leicester, United Kingdom, Le5 4PW
        • Research Site
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
        • Research Site
      • Salford, United Kingdom, M6 8HD
        • Research Site
      • Shrewsbury, United Kingdom, SY3 8XQ
        • Research Site
      • Stevenage, United Kingdom, SG1 4AB
        • Research Site
      • Stoke On Trent, United Kingdom, ST4 7LN
        • Research Site
      • Swansea, United Kingdom, SA6 6NL
        • Research Site
      • Wolverhampton, United Kingdom, WV10 0QP
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Q2W
Q2W administration of darbepoetin alfa.
Drug: 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.
Other Names:
  • Placebo
Active Comparator: QM
QM administration of darbepoetin alfa
Drug: 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.
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hb Change Between Baseline and the Evaluation Period (Average of Weeks 29-33)
Time Frame: Baseline Week 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.
Baseline Week 33

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Baseline to Week 33
Hb at Baseline
Time Frame: Baseline
Baseline
Hb at Week 3
Time Frame: Week 3
Week 3
Hb at Week 5
Time Frame: Week 5
Week 5
Hb at Week 7
Time Frame: Week 7
Week 7
Hb at Week 9
Time Frame: Week 9
Week 9
Hb at Week 11
Time Frame: Week 11
Week 11
Hb at Week 13
Time Frame: Week 13
Week 13
Hb at Week 15
Time Frame: Week 15
Week 15
Hb at Week 17
Time Frame: Week 17
Week 17
Hb at Week 19
Time Frame: Week 19
Week 19
Hb at Week 21
Time Frame: Week 21
Week 21
Hb at Week 23
Time Frame: Week 23
Week 23
Hb at Week 25
Time Frame: Week 25
Week 25
Hb at Week 27
Time Frame: Week 27
Week 27
Hb at Week 29
Time Frame: Week 29
Week 29
Hb at Week 31
Time Frame: Week 31
Week 31
Hb at Week 33
Time Frame: Week 33
Week 33
Darbepoetin Alfa Dose at Week 1
Time Frame: 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
Week 1
Darbepoetin Alfa Dose at Week 3
Time Frame: 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
Week 3
Darbepoetin Alfa Dose at Week 5
Time Frame: 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
Week 5
Darbepoetin Alfa Dose at Week 7
Time Frame: 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
Week 7
Darbepoetin Alfa Dose at Week 9
Time Frame: 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
Week 9
Darbepoetin Alfa Dose at Week 11
Time Frame: 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
Week 11
Darbepoetin Alfa Dose at Week 13
Time Frame: 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
Week 13
Darbepoetin Alfa Dose at Week 15
Time Frame: 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
Week 15
Darbepoetin Alfa Dose at Week 17
Time Frame: 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
Week 17
Darbepoetin Alfa Dose at Week 19
Time Frame: 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
Week 19
Darbepoetin Alfa Dose at Week 21
Time Frame: 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
Week 21
Darbepoetin Alfa Dose at Week 23
Time Frame: 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
Week 23
Darbepoetin Alfa Dose at Week 25
Time Frame: 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
Week 25
Darbepoetin Alfa Dose at Week 27
Time Frame: 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
Week 27
Darbepoetin Alfa Dose at Week 29
Time Frame: 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
Week 29
Darbepoetin Alfa Dose at Week 31
Time Frame: 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
Week 31
Darbepoetin Alfa Dose During the Evaluation Period (Average of Weeks 29-33)
Time Frame: 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
Weeks 29-33
Ratio of Darbepoetin Alfa Dose to Baseline at Week 3
Time Frame: 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
Week 3
Ratio of Darbepoetin Alfa Dose to Baseline at Week 5
Time Frame: 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
Week 5
Ratio of Darbepoetin Alfa Dose to Baseline at Week 7
Time Frame: 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
Week 7
Ratio of Darbepoetin Alfa Dose to Baseline at Week 9
Time Frame: 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
Week 9
Ratio of Darbepoetin Alfa Dose to Baseline at Week 11
Time Frame: 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
Week 11
Ratio of Darbepoetin Alfa Dose to Baseline at Week 13
Time Frame: 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
Week 13
Ratio of Darbepoetin Alfa Dose to Baseline at Week 15
Time Frame: 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
Week 15
Ratio of Darbepoetin Alfa Dose to Baseline at Week 17
Time Frame: 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
Week 17
Ratio of Darbepoetin Alfa Dose to Baseline at Week 19
Time Frame: 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
Week 19
Ratio of Darbepoetin Alfa Dose to Baseline at Week 21
Time Frame: 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
Week 21
Ratio of Darbepoetin Alfa Dose to Baseline at Week 23
Time Frame: 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
Week 23
Ratio of Darbepoetin Alfa Dose to Baseline at Week 25
Time Frame: 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
Week 25
Ratio of Darbepoetin Alfa Dose to Baseline at Week 27
Time Frame: 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
Week 27
Ratio of Darbepoetin Alfa Dose to Baseline at Week 29
Time Frame: 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
Week 29
Ratio of Darbepoetin Alfa Dose to Baseline at Week 31
Time Frame: 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
Week 31
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)
Time Frame: 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
Weeks 1-33
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
Weeks 1-33
Ratio of Darbepoetin Alfa Dose to Baseline at the Evalaution Period (Average of Weeks 29-33)
Time Frame: Evaluation Period
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Evaluation Period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20060163
  • 2006-003173-27 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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