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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00925587
First received: May 28, 2009
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Anemia
Chronic Kidney Disease
Drug: darbepoetin alfa
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Hb Change Between Baseline and the Evaluation Period (Average of Weeks 29-33) [ Time Frame: Baseline Week 33 ] [ Designated as safety issue: No ]
    The Adjusted Analysis is the primary analysis and includes treatment group and baseline Hb value as covariates. Non-inferiority is concluded if the lower limit of the 95% confidence interval for the mean difference is above -0.5g/dL.


Secondary Outcome Measures:
  • Achievement of Both a Hb >= 10.0 g/dL and a >= 1.0 g/dL Increase From Baseline at Any Time Point Following de Novo Darbepoetin Alfa Administration. [ Time Frame: Baseline to Week 33 ] [ Designated as safety issue: No ]
  • Hb at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Hb at Week 3 [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
  • Hb at Week 5 [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
  • Hb at Week 7 [ Time Frame: Week 7 ] [ Designated as safety issue: No ]
  • Hb at Week 9 [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
  • Hb at Week 11 [ Time Frame: Week 11 ] [ Designated as safety issue: No ]
  • Hb at Week 13 [ Time Frame: Week 13 ] [ Designated as safety issue: No ]
  • Hb at Week 15 [ Time Frame: Week 15 ] [ Designated as safety issue: No ]
  • Hb at Week 17 [ Time Frame: Week 17 ] [ Designated as safety issue: No ]
  • Hb at Week 19 [ Time Frame: Week 19 ] [ Designated as safety issue: No ]
  • Hb at Week 21 [ Time Frame: Week 21 ] [ Designated as safety issue: No ]
  • Hb at Week 23 [ Time Frame: Week 23 ] [ Designated as safety issue: No ]
  • Hb at Week 25 [ Time Frame: Week 25 ] [ Designated as safety issue: No ]
  • Hb at Week 27 [ Time Frame: Week 27 ] [ Designated as safety issue: No ]
  • Hb at Week 29 [ Time Frame: Week 29 ] [ Designated as safety issue: No ]
  • Hb at Week 31 [ Time Frame: Week 31 ] [ Designated as safety issue: No ]
  • Hb at Week 33 [ Time Frame: Week 33 ] [ Designated as safety issue: No ]
  • Darbepoetin Alfa Dose at Week 1 [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  • Darbepoetin Alfa Dose at Week 3 [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  • Darbepoetin Alfa Dose at Week 5 [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  • Darbepoetin Alfa Dose at Week 7 [ Time Frame: Week 7 ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  • Darbepoetin Alfa Dose at Week 9 [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  • Darbepoetin Alfa Dose at Week 11 [ Time Frame: Week 11 ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  • Darbepoetin Alfa Dose at Week 13 [ Time Frame: Week 13 ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  • Darbepoetin Alfa Dose at Week 15 [ Time Frame: Week 15 ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  • Darbepoetin Alfa Dose at Week 17 [ Time Frame: Week 17 ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  • Darbepoetin Alfa Dose at Week 19 [ Time Frame: Week 19 ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  • Darbepoetin Alfa Dose at Week 21 [ Time Frame: Week 21 ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  • Darbepoetin Alfa Dose at Week 23 [ Time Frame: Week 23 ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  • Darbepoetin Alfa Dose at Week 25 [ Time Frame: Week 25 ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  • Darbepoetin Alfa Dose at Week 27 [ Time Frame: Week 27 ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  • Darbepoetin Alfa Dose at Week 29 [ Time Frame: Week 29 ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  • Darbepoetin Alfa Dose at Week 31 [ Time Frame: Week 31 ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  • Darbepoetin Alfa Dose During the Evaluation Period (Average of Weeks 29-33) [ Time Frame: Weeks 29-33 ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  • Ratio of Darbepoetin Alfa Dose to Baseline at Week 3 [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  • Ratio of Darbepoetin Alfa Dose to Baseline at Week 5 [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  • Ratio of Darbepoetin Alfa Dose to Baseline at Week 7 [ Time Frame: Week 7 ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  • Ratio of Darbepoetin Alfa Dose to Baseline at Week 9 [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  • Ratio of Darbepoetin Alfa Dose to Baseline at Week 11 [ Time Frame: Week 11 ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  • Ratio of Darbepoetin Alfa Dose to Baseline at Week 13 [ Time Frame: Week 13 ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  • Ratio of Darbepoetin Alfa Dose to Baseline at Week 15 [ Time Frame: Week 15 ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  • Ratio of Darbepoetin Alfa Dose to Baseline at Week 17 [ Time Frame: Week 17 ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  • Ratio of Darbepoetin Alfa Dose to Baseline at Week 19 [ Time Frame: Week 19 ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  • Ratio of Darbepoetin Alfa Dose to Baseline at Week 21 [ Time Frame: Week 21 ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  • Ratio of Darbepoetin Alfa Dose to Baseline at Week 23 [ Time Frame: Week 23 ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  • Ratio of Darbepoetin Alfa Dose to Baseline at Week 25 [ Time Frame: Week 25 ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  • Ratio of Darbepoetin Alfa Dose to Baseline at Week 27 [ Time Frame: Week 27 ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  • Ratio of Darbepoetin Alfa Dose to Baseline at Week 29 [ Time Frame: Week 29 ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  • Ratio of Darbepoetin Alfa Dose to Baseline at Week 31 [ Time Frame: Week 31 ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  • Dose of Darbepoetin Alfa at the First Achievement of a Hb ≥10.0 g/dL and a ≥1.0 g/dL Increase From Baseline (Weeks 1-33) [ Time Frame: Weeks 1-33 ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  • Time to First Achievement of a Hb ≥10.0 g/dL and a ≥1.0 g/dL Increase From Baseline (Weeks 1-33) [ Time Frame: Weeks 1-33 ] [ Designated as safety issue: No ]
  • Ratio of Darbepoetin Alfa Dose to Baseline at the Evalaution Period (Average of Weeks 29-33) [ Time Frame: Evaluation Period ] [ Designated as safety issue: No ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period


Enrollment: 358
Study Start Date: June 2009
Study Completion Date: May 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925587

  Show 157 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00925587     History of Changes
Other Study ID Numbers: 20060163, 2006-003173-27
Study First Received: May 28, 2009
Results First Received: December 5, 2013
Last Updated: May 15, 2014
Health Authority: Australia: Human Research Ethics Committee
Belgium: Service Public Fédéral Santé Publique, Sécurité de la Chaîne alimentaire et Environnement
Czech Republic: Statni ustav pro kontrolu leciv
Denmark: Danish Medicines Agency
Estonia: State Agency of Medicines
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Italy: Local Ethics Committees
Latvia: State Agency of Medicines
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: Instituto Nacional da Farmácia e do Medicamento (INFARMED)
Romania: Ministry of Health and the Family
Romania: Romanian National Drug Agency
Russia: Ministry of Health
Slovenia: Agency for Medicinal Products and Medicinal Devices of the Republic of Slovenia (ARSZMP)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Bulgaria: Bulgarian Drug Agency
Greece: National Organization of Medicines
Israel: Ministry of Health

Keywords provided by Amgen:
CKD
Anemia
correction
darbepoetin alfa

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014