Clinical trial NCT00925587: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Chronic Kidney Disease
Keywords: CKD
Anemia
correction
darbepoetin alfa
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2009-06-22
Enrollment: 358
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Hb Change Between Baseline and the Evaluation Period (Average of Weeks 29-33)
timeFrame: Baseline Week 33
Secondary outcomes:
measure: 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.
timeFrame: Baseline to Week 33
measure: Hb at Baseline
timeFrame: Baseline
measure: Hb at Week 3
timeFrame: Week 3
measure: Hb at Week 5
timeFrame: Week 5
measure: Hb at Week 7
timeFrame: Week 7
measure: Hb at Week 9
timeFrame: Week 9
measure: Hb at Week 11
timeFrame: Week 11
measure: Hb at Week 13
timeFrame: Week 13
measure: Hb at Week 15
timeFrame: Week 15
measure: Hb at Week 17
timeFrame: Week 17
measure: Hb at Week 19
timeFrame: Week 19
measure: Hb at Week 21
timeFrame: Week 21
measure: Hb at Week 23
timeFrame: Week 23
measure: Hb at Week 25
timeFrame: Week 25
measure: Hb at Week 27
timeFrame: Week 27
measure: Hb at Week 29
timeFrame: Week 29
measure: Hb at Week 31
timeFrame: Week 31
measure: Hb at Week 33
timeFrame: Week 33
measure: Darbepoetin Alfa Dose at Week 1
timeFrame: Week 1
measure: Darbepoetin Alfa Dose at Week 3
timeFrame: Week 3
measure: Darbepoetin Alfa Dose at Week 5
timeFrame: Week 5
measure: Darbepoetin Alfa Dose at Week 7
timeFrame: Week 7
measure: Darbepoetin Alfa Dose at Week 9
timeFrame: Week 9
measure: Darbepoetin Alfa Dose at Week 11
timeFrame: Week 11
measure: Darbepoetin Alfa Dose at Week 13
timeFrame: Week 13
measure: Darbepoetin Alfa Dose at Week 15
timeFrame: Week 15
measure: Darbepoetin Alfa Dose at Week 17
timeFrame: Week 17
measure: Darbepoetin Alfa Dose at Week 19
timeFrame: Week 19
measure: Darbepoetin Alfa Dose at Week 21
timeFrame: Week 21
measure: Darbepoetin Alfa Dose at Week 23
timeFrame: Week 23
measure: Darbepoetin Alfa Dose at Week 25
timeFrame: Week 25
measure: Darbepoetin Alfa Dose at Week 27
timeFrame: Week 27
measure: Darbepoetin Alfa Dose at Week 29
timeFrame: Week 29
measure: Darbepoetin Alfa Dose at Week 31
timeFrame: Week 31
measure: Darbepoetin Alfa Dose During the Evaluation Period (Average of Weeks 29-33)
timeFrame: Weeks 29-33
measure: Ratio of Darbepoetin Alfa Dose to Baseline at Week 3
timeFrame: Week 3
measure: Ratio of Darbepoetin Alfa Dose to Baseline at Week 5
timeFrame: Week 5
measure: Ratio of Darbepoetin Alfa Dose to Baseline at Week 7
timeFrame: Week 7
measure: Ratio of Darbepoetin Alfa Dose to Baseline at Week 9
timeFrame: Week 9
measure: Ratio of Darbepoetin Alfa Dose to Baseline at Week 11
timeFrame: Week 11
measure: Ratio of Darbepoetin Alfa Dose to Baseline at Week 13
timeFrame: Week 13
measure: Ratio of Darbepoetin Alfa Dose to Baseline at Week 15
timeFrame: Week 15
measure: Ratio of Darbepoetin Alfa Dose to Baseline at Week 17
timeFrame: Week 17
measure: Ratio of Darbepoetin Alfa Dose to Baseline at Week 19
timeFrame: Week 19
measure: Ratio of Darbepoetin Alfa Dose to Baseline at Week 21
timeFrame: Week 21
measure: Ratio of Darbepoetin Alfa Dose to Baseline at Week 23
timeFrame: Week 23
measure: Ratio of Darbepoetin Alfa Dose to Baseline at Week 25
timeFrame: Week 25
measure: Ratio of Darbepoetin Alfa Dose to Baseline at Week 27
timeFrame: Week 27
measure: Ratio of Darbepoetin Alfa Dose to Baseline at Week 29
timeFrame: Week 29
measure: Ratio of Darbepoetin Alfa Dose to Baseline at Week 31
timeFrame: Week 31
measure: 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)
timeFrame: Weeks 1-33
measure: Time to First Achievement of a Hb ≥10.0 g/dL and a ≥1.0 g/dL Increase From Baseline (Weeks 1-33)
timeFrame: Weeks 1-33
measure: Ratio of Darbepoetin Alfa Dose to Baseline at the Evalaution Period (Average of Weeks 29-33)
timeFrame: Evaluation Period
Other outcomes:
Locations:
city: Gosford
country: Australia
facility: Research Site
state: New South Wales
city: Liverpool
country: Australia
facility: Research Site
state: New South Wales
city: New Lambton
country: Australia
facility: Research Site
state: New South Wales
city: Randwick
country: Australia
facility: Research Site
state: New South Wales
city: Cairns
country: Australia
facility: Research Site
state: Queensland
city: Box Hill
country: Australia
facility: Research Site
state: Victoria
city: Footscray
country: Australia
facility: Research Site
state: Victoria
city: Parkville
country: Australia
facility: Research Site
state: Victoria
city: Reservoir
country: Australia
facility: Research Site
state: Victoria
city: Bruxelles
country: Belgium
facility: Research Site
city: Bruxelles
country: Belgium
facility: Research Site
city: Edegem
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: LiÃ¨ge
country: Belgium
facility: Research Site
city: Roeselare
country: Belgium
facility: Research Site
city: Pleven
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Brno
country: Czech Republic
facility: Research Site
city: Chrudim
country: Czech Republic
facility: Research Site
city: Jilemnice
country: Czech Republic
facility: Research Site
city: Kladno
country: Czech Republic
facility: Research Site
city: Liberec 1
country: Czech Republic
facility: Research Site
city: Novy Jicin
country: Czech Republic
facility: Research Site
city: Plzen
country: Czech Republic
facility: Research Site
city: Praha 10
country: Czech Republic
facility: Research Site
city: Praha 4 - Nusle
country: Czech Republic
facility: Research Site
city: Praha 4
country: Czech Republic
facility: Research Site
city: Praha 6
country: Czech Republic
facility: Research Site
city: Praha 6
country: Czech Republic
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city: Praha 8
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city: Slavkov u Brna
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city: Sternberk
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city: Usti nad Orlici
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city: Roskilde
country: Denmark
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city: Viborg
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city: Ã…rhus
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city: Tallinn
country: Estonia
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city: Tallinn
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city: Annonay
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city: Creil
country: France
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city: Grenoble
country: France
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city: Metz
country: France
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city: Montivilliers
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city: Nice
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city: Poissy
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city: Reims Cedex
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city: Coesfeld
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city: Hamburg
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city: Leverkusen
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city: Alexandroupoli
country: Greece
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city: Athens
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city: Larissa
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city: Thessaloniki
country: Greece
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city: Thessaloniki
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city: Baja
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city: Debrecen
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city: Gyor
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city: Kaposvar
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city: Pecs
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city: Szekszard
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city: Szombathely
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city: Zalaegerszeg
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city: Ashkelon
country: Israel
facility: Research Site
city: Hadera
country: Israel
facility: Research Site
city: Jerusalem
country: Israel
facility: Research Site
city: Albano Laziale RM
country: Italy
facility: Research Site
city: Ancona
country: Italy
facility: Research Site
city: Cagliari
country: Italy
facility: Research Site
city: Firenze
country: Italy
facility: Research Site
city: Lecco
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Pavia
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Torino
country: Italy
facility: Research Site
city: Torino
country: Italy
facility: Research Site
city: Daugavpils
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Valmiera
country: Latvia
facility: Research Site
city: Ventspils
country: Latvia
facility: Research Site
city: Saltillo
country: Mexico
facility: Research Site
state: Coahuila
city: Guadalajara
country: Mexico
facility: Research Site
state: Jalisco
city: Cuernavaca
country: Mexico
facility: Research Site
state: Morelos
city: Queretaro
country: Mexico
facility: Research Site
state: QuerÃ©taro
city: San Luis Potosi
country: Mexico
facility: Research Site
state: San Luis PotosÃ-
city: Choszczno
country: Poland
facility: Research Site
city: Golub-Dobrzyn
country: Poland
facility: Research Site
city: Koscierzyna
country: Poland
facility: Research Site
city: Koszalin
country: Poland
facility: Research Site
city: Legnica
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Warszawa
country: Poland
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city: Zamosc
country: Poland
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city: Evora
country: Portugal
facility: Research Site
city: Faro
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Porto
country: Portugal
facility: Research Site
city: SetÃºbal
country: Portugal
facility: Research Site
city: Bucharest
country: Romania
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city: Bucharest
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
city: Ekaterinburg
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: Belgrade
country: Serbia
facility: Research Site
city: Krgujevac
country: Serbia
facility: Research Site
city: Zemun
country: Serbia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Galanta
country: Slovakia
facility: Research Site
city: Namestovo
country: Slovakia
facility: Research Site
city: Sala
country: Slovakia
facility: Research Site
city: Trstena
country: Slovakia
facility: Research Site
city: Zvolen
country: Slovakia
facility: Research Site
city: Jesenice
country: Slovenia
facility: Research Site
city: Novo mesto
country: Slovenia
facility: Research Site
city: Sempeter pri Gorici
country: Slovenia
facility: Research Site
city: Slovenj Gradec
country: Slovenia
facility: Research Site
city: JaÃ©n
country: Spain
facility: Research Site
state: AndalucÃ-a
city: Barcelona
country: Spain
facility: Research Site
state: CataluÃ±a
city: L'Hospitalet de Llobregat
country: Spain
facility: Research Site
state: CataluÃ±a
city: Majadahonda
country: Spain
facility: Research Site
state: Madrid
city: Galdakao
country: Spain
facility: Research Site
state: PaÃ-s Vasco
city: Madrid
country: Spain
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Brighton
country: United Kingdom
facility: Research Site
city: Cambridge
country: United Kingdom
facility: Research Site
city: Coventry
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Hull
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: Research Site
city: Salford
country: United Kingdom
facility: Research Site
city: Shrewsbury
country: United Kingdom
facility: Research Site
city: Stevenage
country: United Kingdom
facility: Research Site
city: Stoke On Trent
country: United Kingdom
facility: Research Site
city: Swansea
country: United Kingdom
facility: Research Site
city: Wolverhampton
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
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.