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Completed

NCT Number: NCT00925587

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

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.

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Key information

Conditions

Anemia Chronic Disease Chronic Kidney Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Gosford, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

darbepoetin alfa

Drug

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 names: Placebo

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 22, 2009
Registry last updated
Jun 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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