AnemiaPhase 3NCT00925587

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

A Phase 3 study testing darbepoetin alfa in people with Anemia and Chronic Kidney Disease, run by Amgen at 157 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Anemia, Chronic Kidney Disease
What is being tested?: darbepoetin alfa
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 358 participants
Where: 157 sitesin 23 countries
Study dates: Jun 2009to May 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

≥ 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%

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

157 sites in 23 countries.

Country

City, postcode or hospital

157 sites in 23 countries

Czechia16 sites

Research Site
Brno, 615 00
Research Site
Chrudim, 537 27
Research Site
Jilemnice, 514 15
Research Site
Kladno, 272 59
Research Site
Liberec, 460 03
Research Site
Nový Jičín, 741 01
Research Site
Pilsen, 301 00
Research Site
Prague, 100 34
Research Site
Prague, 149 00
Research Site
Prague, 160 00
Research Site
Prague, 169 00
Research Site
Prague, 181 02
Research Site
Praha 4 - Nusle, 140 00
Research Site
Slavkov u Brna, 684 01
Research Site
Sternberk, 785 01
Research Site
Ústí nad Orlicí, 562 18

Other trials in Czechia

United Kingdom14 sites

Research Site
Birmingham, B9 5SS
Research Site
Brighton, BN2 5BE
Research Site
Cambridge, CB2 2QQ
Research Site
Coventry, CV2 2DX
Research Site
Glasgow, G11 6NT
Research Site
Hull, HU3 2JZ
Research Site
Leicester, LE5 4PW
Research Site
Newcastle upon Tyne, NE7 7DN
Research Site
Salford, M6 8HD
Research Site
Shrewsbury, SY3 8XQ
Research Site
Stevenage, SG1 4AB
Research Site
Stoke-on-Trent, ST4 7LN
Research Site
Swansea, SA6 6NL
Research Site
Wolverhampton, WV10 0QP

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Poland11 sites

Research Site
Choszczno, 73-200
Research Site
Golub-Dobrzyń, 87-400
Research Site
Kościerzyna, 83-400
Research Site
Koszalin, 75-581
Research Site
Legnica, 59-220
Research Site
Lodz, 90-549
Research Site
Lodz, 93-120
Research Site
Lublin, 20-954
Research Site
Poznan, 61-289
Research Site
Warsaw, 04-749
Research Site
Zamość, 87-100

Other trials in Poland

France10 sites

Research Site
Annonay, 07100
Research Site
Creil, 60100
Research Site
Grenoble, 38000
Research Site
Metz, 57000
Research Site
Montivilliers, 76290
Research Site
Nice, 06000
Research Site
Poissy, 78300
Research Site
Reims, 51092
Research Site
Rouen, 76031
Research Site
Saint-Priest-en-Jarez, 42270

Other trials in France

Hungary10 sites

Research Site
Baja, 6500
Research Site
Budapest, 1115
Research Site
Debrecen, 4012
Research Site
Esztergom, 2500
Research Site
Győr, 9023
Research Site
Kaposvár, 7400
Research Site
Pécs, 7624
Research Site
Szekszárd, 7100
Research Site
Szombathely, 9700
Research Site
Zalaegerszeg, 8900

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Italy10 sites

Research Site
Albano Laziale RM, 00041
Research Site
Ancona, 60125
Research Site
Cagliari, 09134
Research Site
Florence, 50141
Research Site
Lecco, 23900
Research Site
Naples, 80131
Research Site
Pavia, 27100
Research Site
Roma, 00189
Research Site
Torino, 10126
Research Site
Torino, 10154

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Australia9 sites

Research Site
Box Hill, Victoria, 3128
Research Site
Cairns, Queensland, 4870
Research Site
Footscray, Victoria, 3011
Research Site
Gosford, New South Wales, 2250
Research Site
Liverpool, New South Wales, 2170
Research Site
New Lambton, New South Wales, 2305
Research Site
Parkville, Victoria, 3050
Research Site
Randwick, New South Wales, 2031
Research Site
Reservoir, Victoria, 3073

Other trials in Australia

Belgium7 sites

Research Site
Brussels, 1020
Research Site
Brussels, 1200
Research Site
Edegem, 2650
Research Site
Ghent, 9000
Research Site
Leuven, 3000
Research Site
LiÃ¨ge, 4000
Research Site
Roeselare, 8800

Other trials in Belgium

Russia7 sites

Research Site
Moscow, 117036
Research Site
Moscow, 123183
Research Site
Moscow, 125284
Research Site
Saint Petersburg, 191104
Research Site
Saint Petersburg, 195067
Research Site
Saint Petersburg, 196247
Research Site
Yekaterinburg, 620102

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Latvia6 sites

Research Site
Daugavpils, 5417
Research Site
Riga, 1001
Research Site
Riga, 1002
Research Site
Riga, 1038
Research Site
Valmiera, 4201
Research Site
Ventspils, 3600

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Romania6 sites

Research Site
Bucharest, 010731
Research Site
Bucharest, 014461
Research Site
Bucharest, 022328
Research Site
Bucharest, 050098
Research Site
Iași, 700503
Research Site
Timișoara, 300736

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Slovakia6 sites

Research Site
Bratislava, 831 03
Research Site
Galanta, 924 22
Research Site
Námestovo, 029 01
Research Site
Šaľa, 927 19
Research Site
Trstená, 028 01
Research Site
Zvolen, 960 01

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Spain6 sites

Research Site
Barcelona, CataluÃ±a, 08036
Research Site
Galdakao, PaÃ-s Vasco, 48960
Research Site
JaÃ©n, AndalucÃ-a, 23007
Research Site
L'Hospitalet de Llobregat, CataluÃ±a, 08907
Research Site
Madrid, Madrid, 28046
Research Site
Majadahonda, Madrid, 28222

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Germany5 sites

Research Site
Bernkastel-Kues, 54470
Research Site
Coesfeld, 48653
Research Site
DÃ¼sseldorf, 40210
Research Site
Hamburg, 22297
Research Site
Leverkusen, 51373

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Greece5 sites

Research Site
Alexandroupoli, 68100
Research Site
Athens, 11528
Research Site
Larissa, 41110
Research Site
Thessaloniki, 54636
Research Site
Thessaloniki, 54642

Other trials in Greece

Mexico5 sites

Research Site
Cuernavaca, Morelos, 62448
Research Site
Guadalajara, Jalisco, 44140
Research Site
Querétaro, QuerÃ©taro, 76178
Research Site
Saltillo, Coahuila, 25230
Research Site
San Luis Potosí City, San Luis PotosÃ-, 78240

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Portugal5 sites

Research Site
Evora, 7000-811
Research Site
Faro, 8000-386
Research Site
Lisbon, 1649-035
Research Site
Porto, 4099-001
Research Site
SetÃºbal, 2910-446

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Bulgaria4 sites

Research Site
Pleven, 5800
Research Site
Sofia, 1431
Research Site
Sofia, 1709
Research Site
Varna, 9010

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Slovenia4 sites

Research Site
Jesenice, 4270
Research Site
Novo Mesto, 8000
Research Site
Sempeter pri Gorici, 5290
Research Site
Slovenj Gradec, 2380

Other trials in Slovenia

Denmark3 sites

Research Site
Ã…rhus, 8200
Research Site
Roskilde, 4000
Research Site
Viborg, 8800

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Israel3 sites

Research Site
Ashkelon, 78278
Research Site
Hadera, 38100
Research Site
Jerusalem, 91031

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Serbia3 sites

Research Site
Belgrade, 11000
Research Site
Krgujevac, 34000
Research Site
Zemun, 11080

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Estonia2 sites

Research Site
Tallinn, 10617
Research Site
Tallinn, 13419

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About this study

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

Conditions: Anemia, Chronic Kidney Disease
Being tested: darbepoetin alfa
Keywords: CKD, Anemia, correction, darbepoetin alfa
Medical subject headings: Anemia, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

darbepoetin alfaDrug
Also called Placebo
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.

Study groups in NCT00925587
Study group	Role	What they receive
Q2W	Active comparator	Q2W administration of darbepoetin alfa. Receives: Drug: darbepoetin alfa
QM	Active comparator	QM administration of darbepoetin alfa Receives: Drug: darbepoetin alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline Week 33

Secondary outcomes (53)

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.
Measured: Baseline to Week 33
Hb at Baseline
Measured: Baseline
Hb at Week 3
Measured: Week 3
Hb at Week 5
Measured: Week 5
Hb at Week 7
Measured: Week 7
Hb at Week 9
Measured: Week 9
Hb at Week 11
Measured: Week 11
Hb at Week 13
Measured: Week 13
Hb at Week 15
Measured: Week 15
Hb at Week 17
Measured: Week 17
Hb at Week 19
Measured: Week 19
Hb at Week 21
Measured: Week 21
Hb at Week 23
Measured: Week 23
Hb at Week 25
Measured: Week 25
Hb at Week 27
Measured: Week 27
Hb at Week 29
Measured: Week 29
Hb at Week 31
Measured: Week 31
Hb at Week 33
Measured: 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
Measured: Week 1
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
Measured: Week 3
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
Measured: Week 5
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
Measured: Week 7
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
Measured: Week 9
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
Measured: Week 11
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
Measured: Week 13
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
Measured: Week 15
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
Measured: Week 17
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
Measured: Week 19
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
Measured: Week 21
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
Measured: Week 23
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
Measured: Week 25
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
Measured: Week 27
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
Measured: Week 29
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
Measured: Week 31
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
Measured: Weeks 29-33
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
Measured: Week 3
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
Measured: Week 5
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
Measured: Week 7
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
Measured: Week 9
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
Measured: Week 11
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
Measured: Week 13
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
Measured: Week 15
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
Measured: Week 17
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
Measured: Week 19
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
Measured: Week 21
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
Measured: Week 23
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
Measured: Week 25
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
Measured: Week 27
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
Measured: Week 29
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
Measured: 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)
Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period
Measured: 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)
Measured: 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
Measured: Evaluation Period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2009May 2012

First posted22 Jun 2009 (estimated)
Study startJun 2009
Primary completionApr 2012
Study completionMay 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AnemiaStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 358 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00925587
Sponsor's protocol ID: 20060163
Other IDs: 2006-003173-27
Status last verified: May 2014
First submitted: 28 May 2009
Last updated: 4 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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.
PubMed 24506498

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00925587
Acronym / sponsor ID: 20060163
Conditions: Anemia, Chronic Kidney Disease
Keywords: CKD, Anemia, correction, darbepoetin alfa
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 358 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: Jun 2009
Primary completion: Apr 2012 (actual)
Study completion: May 2012 (actual)
First posted: 22 Jun 2009 (estimated)
Results: Posted 4 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Q2W	Active comparator	Drug: darbepoetin alfaQ2W administration of darbepoetin alfa.
QM	Active comparator	Drug: darbepoetin alfaQM administration of darbepoetin alfa

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

≥ 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%

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
darbepoetin alfaAlso: PlaceboDrug 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.	Drug	Q2W, QM

Primary outcome

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.

53 secondary outcomes

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
Hb at Baseline
Time frame: Baseline
Hb at Week 3
Time frame: Week 3
Hb at Week 5
Time frame: Week 5
Hb at Week 7
Time frame: Week 7
Hb at Week 9
Time frame: Week 9
Hb at Week 11
Time frame: Week 11
Hb at Week 13
Time frame: Week 13
Hb at Week 15
Time frame: Week 15
Hb at Week 17
Time frame: Week 17
Hb at Week 19
Time frame: Week 19
Hb at Week 21
Time frame: Week 21
Hb at Week 23
Time frame: Week 23
Hb at Week 25
Time frame: Week 25
Hb at Week 27
Time frame: Week 27
Hb at Week 29
Time frame: Week 29
Hb at Week 31
Time frame: Week 31
Hb at Week 33
Time frame: Week 33
Darbepoetin Alfa Dose at Week 1
Time frame: Week 1
Darbepoetin Alfa Dose at Week 3
Time frame: Week 3
Darbepoetin Alfa Dose at Week 5
Time frame: Week 5
Darbepoetin Alfa Dose at Week 7
Time frame: Week 7
Darbepoetin Alfa Dose at Week 9
Time frame: Week 9
Darbepoetin Alfa Dose at Week 11
Time frame: Week 11
Darbepoetin Alfa Dose at Week 13
Time frame: Week 13
Darbepoetin Alfa Dose at Week 15
Time frame: Week 15
Darbepoetin Alfa Dose at Week 17
Time frame: Week 17
Darbepoetin Alfa Dose at Week 19
Time frame: Week 19
Darbepoetin Alfa Dose at Week 21
Time frame: Week 21
Darbepoetin Alfa Dose at Week 23
Time frame: Week 23
Darbepoetin Alfa Dose at Week 25
Time frame: Week 25
Darbepoetin Alfa Dose at Week 27
Time frame: Week 27
Darbepoetin Alfa Dose at Week 29
Time frame: Week 29
Darbepoetin Alfa Dose at Week 31
Time frame: Week 31
Darbepoetin Alfa Dose During the Evaluation Period (Average of Weeks 29-33)
Time frame: Weeks 29-33
Ratio of Darbepoetin Alfa Dose to Baseline at Week 3
Time frame: Week 3
Ratio of Darbepoetin Alfa Dose to Baseline at Week 5
Time frame: Week 5
Ratio of Darbepoetin Alfa Dose to Baseline at Week 7
Time frame: Week 7
Ratio of Darbepoetin Alfa Dose to Baseline at Week 9
Time frame: Week 9
Ratio of Darbepoetin Alfa Dose to Baseline at Week 11
Time frame: Week 11

Results and safety

Results posted to the registry on 4 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Darbepoetin Alfa Q2W	178	142
Darbepoetin Alfa QM	180	155

Primary outcome: Hb Change Between Baseline and the Evaluation Period (Average of Weeks 29-33)

Time frame: Baseline Week 33. Least squares mean (95% Confidence Interval). Unit: g/dL

Measure	Darbepoetin Alfa Q2W n = 142	Darbepoetin Alfa QM n = 154
Value	2.157 (1.984 to 2.330)	1.969 (1.803 to 2.135)

Darbepoetin Alfa Q2W vs Darbepoetin Alfa QM: Mean Difference (Final Values): -0.188 (95% CI -0.427 to 0.052)

Population analysed: Primary Analysis Set: All subjects receiving at least one dose of darbepoetin alfa in the treatment group to which they were randomized and with at least one evaluable (not within 90 days after an RBC transfusion) Hb measurement during the evaluation period (Weeks 29-33)

53 secondary outcomes are reported in the full results.

Adverse events

Time frame: 33 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Darbepoetin Alfa Q2W	52 of 175 (29.7%)	68 of 175 (38.9%)	Not reported
Darbepoetin Alfa QM	54 of 180 (30%)	63 of 180 (35%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24506498Roger 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.
AmgenTrials clinical trials websiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

157 sites in 23 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing darbepoetin alfa in people with Anemia and Chronic Kidney Disease, run by Amgen at 157 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 157 sites in Czechia, United Kingdom, Poland, France, Hungary and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hb Change Between Baseline and the Evaluation Period (Average of Weeks 29-33) (time frame: Baseline Week 33). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00925587, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2014.