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

Anemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00925587
• Other study ID #: 20060163
• Secondary ID: 2006-003173-27
• Status: Completed
• Phase: Phase 3
• First received: May 28, 2009
• Last updated: May 15, 2014
• Start date: June 2009
• Est. completion date: May 2012

Study information

• Verified date: May 2014
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeBelgium: Service Public Fédéral Santé Publique, Sécurité de la Chaîne alimentaire et EnvironnementCzech Republic: Statni ustav pro kontrolu lecivDenmark: Danish Medicines AgencyEstonia: State Agency of MedicinesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyItaly: Local Ethics CommitteesLatvia: State Agency of MedicinesPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPortugal: Instituto Nacional da Farmácia e do Medicamento (INFARMED)Romania: Ministry of Health and the FamilyRomania: Romanian National Drug AgencyRussia: Ministry of HealthSlovenia: Agency for Medicinal Products and Medicinal Devices of the Republic of Slovenia (ARSZMP)Spain: Agencia Española de Medicamentos y Productos SanitariosUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyBulgaria: Bulgarian Drug AgencyGreece: National Organization of MedicinesIsrael: Ministry of Health
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 358
• Est. completion date: May 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
Australia	Research Site	Box Hill	Victoria
Australia	Research Site	Cairns	Queensland
Australia	Research Site	Footscray	Victoria
Australia	Research Site	Gosford	New South Wales
Australia	Research Site	Liverpool	New South Wales
Australia	Research Site	New Lambton	New South Wales
Australia	Research Site	Parkville	Victoria
Australia	Research Site	Randwick	New South Wales
Australia	Research Site	Reservoir	Victoria
Belgium	Research Site	Bruxelles
Belgium	Research Site	Bruxelles
Belgium	Research Site	Edegem
Belgium	Research Site	Gent
Belgium	Research Site	Leuven
Belgium	Research Site	Liège
Belgium	Research Site	Roeselare
Bulgaria	Research Site	Pleven
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Varna
Czech Republic	Research Site	Brno
Czech Republic	Research Site	Chrudim
Czech Republic	Research Site	Jilemnice
Czech Republic	Research Site	Kladno
Czech Republic	Research Site	Liberec 1
Czech Republic	Research Site	Novy Jicin
Czech Republic	Research Site	Plzen
Czech Republic	Research Site	Praha 10
Czech Republic	Research Site	Praha 4
Czech Republic	Research Site	Praha 4 - Nusle
Czech Republic	Research Site	Praha 6
Czech Republic	Research Site	Praha 6
Czech Republic	Research Site	Praha 8
Czech Republic	Research Site	Slavkov u Brna
Czech Republic	Research Site	Sternberk
Czech Republic	Research Site	Usti nad Orlici
Denmark	Research Site	Ã…rhus
Denmark	Research Site	Roskilde
Denmark	Research Site	Viborg
Estonia	Research Site	Tallinn
Estonia	Research Site	Tallinn
France	Research Site	Annonay
France	Research Site	Creil
France	Research Site	Grenoble
France	Research Site	Metz
France	Research Site	Montivilliers
France	Research Site	Nice
France	Research Site	Poissy
France	Research Site	Reims Cedex
France	Research Site	Rouen Cedex
France	Research Site	Saint Priest en Jarez
Germany	Research Site	Bernkastel-Kues
Germany	Research Site	Coesfeld
Germany	Research Site	Düsseldorf
Germany	Research Site	Hamburg
Germany	Research Site	Leverkusen
Greece	Research Site	Alexandroupoli
Greece	Research Site	Athens
Greece	Research Site	Larissa
Greece	Research Site	Thessaloniki
Greece	Research Site	Thessaloniki
Hungary	Research Site	Baja
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
Hungary	Research Site	Esztergom
Hungary	Research Site	Gyor
Hungary	Research Site	Kaposvar
Hungary	Research Site	Pecs
Hungary	Research Site	Szekszard
Hungary	Research Site	Szombathely
Hungary	Research Site	Zalaegerszeg
Israel	Research Site	Ashkelon
Israel	Research Site	Hadera
Israel	Research Site	Jerusalem
Italy	Research Site	Albano Laziale RM
Italy	Research Site	Ancona
Italy	Research Site	Cagliari
Italy	Research Site	Firenze
Italy	Research Site	Lecco
Italy	Research Site	Napoli
Italy	Research Site	Pavia
Italy	Research Site	Roma
Italy	Research Site	Torino
Italy	Research Site	Torino
Latvia	Research Site	Daugavpils
Latvia	Research Site	Riga
Latvia	Research Site	Riga
Latvia	Research Site	Riga
Latvia	Research Site	Valmiera
Latvia	Research Site	Ventspils
Mexico	Research Site	Cuernavaca	Morelos
Mexico	Research Site	Guadalajara	Jalisco
Mexico	Research Site	Queretaro	Querétaro
Mexico	Research Site	Saltillo	Coahuila
Mexico	Research Site	San Luis Potosi	San Luis PotosÃ-
Poland	Research Site	Choszczno
Poland	Research Site	Golub-Dobrzyn
Poland	Research Site	Koscierzyna
Poland	Research Site	Koszalin
Poland	Research Site	Legnica
Poland	Research Site	Lodz
Poland	Research Site	Lodz
Poland	Research Site	Lublin
Poland	Research Site	Poznan
Poland	Research Site	Warszawa
Poland	Research Site	Zamosc
Portugal	Research Site	Evora
Portugal	Research Site	Faro
Portugal	Research Site	Lisboa
Portugal	Research Site	Porto
Portugal	Research Site	Setúbal
Romania	Research Site	Bucharest
Romania	Research Site	Bucharest
Romania	Research Site	Bucharest
Romania	Research Site	Bucharest
Romania	Research Site	Iasi
Romania	Research Site	Timisoara
Russian Federation	Research Site	Ekaterinburg
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Saint-Petersburg
Serbia	Research Site	Belgrade
Serbia	Research Site	Krgujevac
Serbia	Research Site	Zemun
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Galanta
Slovakia	Research Site	Namestovo
Slovakia	Research Site	Sala
Slovakia	Research Site	Trstena
Slovakia	Research Site	Zvolen
Slovenia	Research Site	Jesenice
Slovenia	Research Site	Novo mesto
Slovenia	Research Site	Sempeter pri Gorici
Slovenia	Research Site	Slovenj Gradec
Spain	Research Site	Barcelona	Cataluña
Spain	Research Site	Galdakao	PaÃ-s Vasco
Spain	Research Site	Jaén	AndalucÃ-a
Spain	Research Site	L'Hospitalet de Llobregat	Cataluña
Spain	Research Site	Madrid
Spain	Research Site	Majadahonda	Madrid
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	Brighton
United Kingdom	Research Site	Cambridge
United Kingdom	Research Site	Coventry
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Hull
United Kingdom	Research Site	Leicester
United Kingdom	Research Site	Newcastle Upon Tyne
United Kingdom	Research Site	Salford
United Kingdom	Research Site	Shrewsbury
United Kingdom	Research Site	Stevenage
United Kingdom	Research Site	Stoke On Trent
United Kingdom	Research Site	Swansea
United Kingdom	Research Site	Wolverhampton

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

Australia,  Belgium,  Bulgaria,  Czech Republic,  Denmark,  Estonia,  France,  Germany,  Greece,  Hungary,  Israel,  Italy,  Latvia,  Mexico,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Slovakia,  Slovenia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline Week 33	No
Secondary	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.		Baseline to Week 33	No
Secondary	Hb at Baseline		Baseline	No
Secondary	Hb at Week 3		Week 3	No
Secondary	Hb at Week 5		Week 5	No
Secondary	Hb at Week 7		Week 7	No
Secondary	Hb at Week 9		Week 9	No
Secondary	Hb at Week 11		Week 11	No
Secondary	Hb at Week 13		Week 13	No
Secondary	Hb at Week 15		Week 15	No
Secondary	Hb at Week 17		Week 17	No
Secondary	Hb at Week 19		Week 19	No
Secondary	Hb at Week 21		Week 21	No
Secondary	Hb at Week 23		Week 23	No
Secondary	Hb at Week 25		Week 25	No
Secondary	Hb at Week 27		Week 27	No
Secondary	Hb at Week 29		Week 29	No
Secondary	Hb at Week 31		Week 31	No
Secondary	Hb at Week 33		Week 33	No
Secondary	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	Week 1	No
Secondary	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	Week 3	No
Secondary	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	Week 5	No
Secondary	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	Week 7	No
Secondary	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	Week 9	No
Secondary	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	Week 11	No
Secondary	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	Week 13	No
Secondary	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	Week 15	No
Secondary	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	Week 17	No
Secondary	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	Week 19	No
Secondary	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	Week 21	No
Secondary	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	Week 23	No
Secondary	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	Week 25	No
Secondary	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	Week 27	No
Secondary	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	Week 29	No
Secondary	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	Week 31	No
Secondary	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	Weeks 29-33	No
Secondary	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	Week 3	No
Secondary	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	Week 5	No
Secondary	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	Week 7	No
Secondary	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	Week 9	No
Secondary	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	Week 11	No
Secondary	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	Week 13	No
Secondary	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	Week 15	No
Secondary	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	Week 17	No
Secondary	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	Week 19	No
Secondary	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	Week 21	No
Secondary	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	Week 23	No
Secondary	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	Week 25	No
Secondary	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	Week 27	No
Secondary	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	Week 29	No
Secondary	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	Week 31	No
Secondary	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	Weeks 1-33	No
Secondary	Time to First Achievement of a Hb =10.0 g/dL and a =1.0 g/dL Increase From Baseline (Weeks 1-33)		Weeks 1-33	No
Secondary	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	Evaluation Period	No

External Links

•   AmgenTrials clinical trials website