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Completed

NCT Number: NCT00436995

Extension From Weekly to Once Every Other Week Darbepoetin Alfa Administration in Subjects With Chronic Kidney Disease Receiving Dialysis

The purpose of this study is to assess the proportion of subjects sucessfully achieving a mean Hemoglobin greater than or equal to 11 g/dL during the evaluation period following extension from Weekly (QW) to Once Every Other Week (Q2W) Darbepoetin Alfa administraion.

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Key information

Conditions

Chronic Kidney Disease Anemia Chronic 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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Receiving dialysis for 3 months or more before enrollment.
  • The mean of 2 screening Hb values taken at least 7 days appart must be greater than or equal to 11g/dL and less than or equal to 13.0 g/dL
  • Receiving stable QW darbepoetin alfa doses for at least 6 weeks before enrollment
  • Adequate iron stores (serum ferritin equal to or greater than 100 ug/L

Exclusion criteria

  • Uncontrolled hypertension
  • Prior history of Cardiovascular Incidents 12 weeks prior to enrollment
  • Other hematological disorders
  • Upper or lower GI bleed within the prior 6 months

Treatment and study plan

darbepoetin alfa

Drug

Administered IV or SC, Q2W at the following unit doses: 10, 15, 20, 30, 40, 50, 60, 80, 100, 130, 150, 200 or 300ug. Initial Q2W dose calculated from pre-enrollment QW doses. Doses titrated to achieve target Hb.

Primary outcomes

  1. Haemoglobin values to be maintained at greater than 11.0 g/dL during the evaluation period.

    Time frame: 33 weeks

Secondary outcomes

  1. Q2W doses over duration of study.

    Time frame: 33 weeks

  2. Hb values during the evaluation period.

    Time frame: 33 weeks

  3. adverse events during study

    Time frame: 33 weeks

  4. Hb Rate of Rise during study and excursions above 14g/dL

    Time frame: 33 weeks

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Multicentre, Single Arm Study Evaluating The Extension From Weekly To Once Every Other Week Darbepoetin Alfa Administration In Subjects With Chronic Kidney Disease Receiving Dialysis.

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Feb 19, 2007
Registry last updated
Jan 21, 2011

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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