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

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ClinicalTrials.gov Identifier: NCT00925587
Recruitment Status : Completed
First Posted : June 22, 2009
Results First Posted : June 4, 2014
Last Update Posted : June 4, 2014
Sponsor:
Information provided by (Responsible Party):
Amgen

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.

Condition or disease Intervention/treatment Phase
Anemia Chronic Kidney Disease Drug: darbepoetin alfa Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 358 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : June 2009
Actual Primary Completion Date : April 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. Hb at Baseline [ Time Frame: Baseline ]
  3. Hb at Week 3 [ Time Frame: Week 3 ]
  4. Hb at Week 5 [ Time Frame: Week 5 ]
  5. Hb at Week 7 [ Time Frame: Week 7 ]
  6. Hb at Week 9 [ Time Frame: Week 9 ]
  7. Hb at Week 11 [ Time Frame: Week 11 ]
  8. Hb at Week 13 [ Time Frame: Week 13 ]
  9. Hb at Week 15 [ Time Frame: Week 15 ]
  10. Hb at Week 17 [ Time Frame: Week 17 ]
  11. Hb at Week 19 [ Time Frame: Week 19 ]
  12. Hb at Week 21 [ Time Frame: Week 21 ]
  13. Hb at Week 23 [ Time Frame: Week 23 ]
  14. Hb at Week 25 [ Time Frame: Week 25 ]
  15. Hb at Week 27 [ Time Frame: Week 27 ]
  16. Hb at Week 29 [ Time Frame: Week 29 ]
  17. Hb at Week 31 [ Time Frame: Week 31 ]
  18. Hb at Week 33 [ Time Frame: Week 33 ]
  19. Darbepoetin Alfa Dose at Week 1 [ Time Frame: 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

  20. Darbepoetin Alfa Dose at Week 3 [ Time Frame: 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

  21. Darbepoetin Alfa Dose at Week 5 [ Time Frame: 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

  22. Darbepoetin Alfa Dose at Week 7 [ Time Frame: 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

  23. Darbepoetin Alfa Dose at Week 9 [ Time Frame: 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

  24. Darbepoetin Alfa Dose at Week 11 [ Time Frame: 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

  25. Darbepoetin Alfa Dose at Week 13 [ Time Frame: 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

  26. Darbepoetin Alfa Dose at Week 15 [ Time Frame: 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

  27. Darbepoetin Alfa Dose at Week 17 [ Time Frame: 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

  28. Darbepoetin Alfa Dose at Week 19 [ Time Frame: 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

  29. Darbepoetin Alfa Dose at Week 21 [ Time Frame: 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

  30. Darbepoetin Alfa Dose at Week 23 [ Time Frame: 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

  31. Darbepoetin Alfa Dose at Week 25 [ Time Frame: 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

  32. Darbepoetin Alfa Dose at Week 27 [ Time Frame: 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

  33. Darbepoetin Alfa Dose at Week 29 [ Time Frame: 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

  34. Darbepoetin Alfa Dose at Week 31 [ Time Frame: 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

  35. Darbepoetin Alfa Dose During the Evaluation Period (Average of Weeks 29-33) [ Time Frame: 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

  36. Ratio of Darbepoetin Alfa Dose to Baseline at Week 3 [ Time Frame: 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

  37. Ratio of Darbepoetin Alfa Dose to Baseline at Week 5 [ Time Frame: 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

  38. Ratio of Darbepoetin Alfa Dose to Baseline at Week 7 [ Time Frame: 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

  39. Ratio of Darbepoetin Alfa Dose to Baseline at Week 9 [ Time Frame: 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

  40. Ratio of Darbepoetin Alfa Dose to Baseline at Week 11 [ Time Frame: 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

  41. Ratio of Darbepoetin Alfa Dose to Baseline at Week 13 [ Time Frame: 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

  42. Ratio of Darbepoetin Alfa Dose to Baseline at Week 15 [ Time Frame: 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

  43. Ratio of Darbepoetin Alfa Dose to Baseline at Week 17 [ Time Frame: 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

  44. Ratio of Darbepoetin Alfa Dose to Baseline at Week 19 [ Time Frame: 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

  45. Ratio of Darbepoetin Alfa Dose to Baseline at Week 21 [ Time Frame: 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

  46. Ratio of Darbepoetin Alfa Dose to Baseline at Week 23 [ Time Frame: 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

  47. Ratio of Darbepoetin Alfa Dose to Baseline at Week 25 [ Time Frame: 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

  48. Ratio of Darbepoetin Alfa Dose to Baseline at Week 27 [ Time Frame: 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

  49. Ratio of Darbepoetin Alfa Dose to Baseline at Week 29 [ Time Frame: 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

  50. Ratio of Darbepoetin Alfa Dose to Baseline at Week 31 [ Time Frame: 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

  51. 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 ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period

  52. 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 ]
  53. Ratio of Darbepoetin Alfa Dose to Baseline at the Evalaution Period (Average of Weeks 29-33) [ Time Frame: Evaluation Period ]
    Although the endpoint is related to dose, the sample is from the Primary Analysis Set which requires a Hb value in the evaluation period



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00925587


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

Additional Information:
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 ( EudraCT Number )
First Posted: June 22, 2009    Key Record Dates
Results First Posted: June 4, 2014
Last Update Posted: June 4, 2014
Last Verified: May 2014

Keywords provided by Amgen:
CKD
Anemia
correction
darbepoetin alfa

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Darbepoetin alfa
Hematinics