Study Evaluating Once Monthly Darbepoetin Alfa Dosing for the Correction of Anemia in Non-dialysis Patients With Chronic Kidney Disease


Tracking Information

Start Date  ICMJEJune 2009
Estimated Primary Completion DateJuly 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: June 18, 2009)		Hb change between baseline and the evaluation period (weeks 29-33) [ Time Frame: Baseline to Week 33 (end of study) ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00925587 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: June 18, 2009)
  • 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 (end of study) ] [ Designated as safety issue: No ]
  • Darbepoetin alfa doses over duration of study [ Time Frame: Baseline to Week 33 (end of study) ] [ Designated as safety issue: No ]
  • Safety profiles of darbepoetin alfa administered de novo QM and Q2W [ Time Frame: Baseline to Week 33 (end of study) ] [ Designated as safety issue: Yes ]
  • Hb at each scheduled time point during the study [ Time Frame: Baseline to week 33 (end of study) ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEStudy Evaluating Once Monthly Darbepoetin Alfa Dosing for the Correction of Anemia in Non-dialysis Patients With Chronic Kidney Disease
Official Title  ICMJEA 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
Brief Summary

The purpose of this study is to determine whether taking darbepoetin alfa once monthly is as safe and effective in raising red blood cell levels as taking darbepoetin alfa once every 2 weeks.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJE
  • Anemia
  • Chronic Kidney Disease
Intervention  ICMJEDrug: 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
Study Arms / Comparison Groups
  • Q2W: Active Comparator
    Q2W administration of darbepoetin alfa.
    Intervention: Drug: darbepoetin alfa
  • QM: Active Comparator
    QM administration of darbepoetin alfa
    Intervention: Drug: darbepoetin alfa

Recruitment Information

Estimated Enrollment  ICMJE540
Estimated Completion DateSeptember 2011
Estimated Primary Completion DateJuly 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Amgen Call Center866-572-6436
Location Countries  ICMJEAustralia,   Belgium,   Czech Republic,   Denmark,   Estonia,   France,   Germany,   Hungary,   Italy,   Latvia,   Poland,   Portugal,   Russian Federation,   Spain,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00925587
Responsible PartyGlobal Development Leader, Amgen Inc.
Study ID Numbers  ICMJE20060163
Study Sponsor  ICMJEAmgen
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:MDAmgen
Information Provided ByAmgen