Treatment for Subjects With Chronic Kidney Disease Receiving Haemodialysis

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00116701
First received: June 30, 2005
Last updated: May 1, 2008
Last verified: May 2008

June 30, 2005
May 1, 2008
May 2005
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  • Treatment period 1: Mean haemoglobin during the evaluation period (weeks 21-24)
  • Treatment period 2: Mean haemoglobin during evaluation period 2 (weeks 45-48)
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Complete list of historical versions of study NCT00116701 on ClinicalTrials.gov Archive Site
  • Treatment period 2: Change in Hb between Evaluation Period 1 and Evaluation Period 2
  • Treatment period 2: The proportion of subjects with a change in Hb between Evaluation Period 1 and Evaluation Period 2 within the inclusive range -1.0 to +1.5 g/dL
  • Treatment period 2: The proportion of subjects with a mean Hb > 11.0 g/dL during Evaluation Period 2
  • Treatment period 2: Dose and frequency of darbepoetin alfa administration over the treatment period
  • Treatment period 1:The proportion of subjects with a mean Hb > 11.0 g/dL during the evaluation period
  • Treatment period 1: Change in Hb between screening/baseline and the evaluation period
  • Treatment period 1: Dose and frequency of darbepoetin alfa administration over the treatment period
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Treatment for Subjects With Chronic Kidney Disease Receiving Haemodialysis
A Study to Evaluate the Efficacy of Converting From Intravenous or Subcutaneous rHuEPO to Intravenous Darbepoetin Alfa (Aranesp®) in Subjects With Chronic Kidney Disease Receiving Haemodialysis

Treatment period 1:To demonstrate that switching HD subjects with a baseline haemoglobin (Hb) ≥ 10 g/dL and ≤ 13 g/dL from either subcutaneous (SC) or intravenous (IV) rHuEPO to IV darbepoetin alfa results in a mean Hb > 11 g/dL.

Treatment Period 2:To demonstrate that switching subjects with a Hb > 11 g/dL and ≤ 13 g/dL from once weekly IV darbepoetin alfa to once every 2 weeks (Q2W) maintains the mean Hb at > 11 g/dL.

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Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Disease
Drug: Aranesp®
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
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Inclusion Criteria: -at least 18 years old - Diagnosis of chronic kidney disease (CKD) and receiving dialysis for at least 3 months prior to screening - Baseline Hb level greater than or equal to 10.0 g/dL and less than or equal to 13.0 g/dL - Adequate iron stores (defined as serum ferritin greater than or equal to 100 µg/L or transferrin saturation [TSAT] greater than or equal to 20%) - Stable IV (epoetin alfa or beta) or SC rHuEPO (epoetin beta) therapy 2 or 3 times per week for at least 8 weeks before screening (stable is defined as less than 25% change in weekly dose and no change in frequency or route) - All subjects must practice adequate contraception (in the judgment of the investigator) throughout this trial. Exclusion Criteria: - Received SC epoetin alfa in the 12 months before screening - Uncontrolled hypertension (diastolic blood pressure greater than 100 mmHg or systolic blood pressure greater than 180 mmHg on 2 separate occasions during screening) - Prior history (within 12 weeks before enrolment) of cardiovascular events including:

  • acute myocardial ischemia;
  • hospitalization for congestive heart failure;
  • myocardial infarction. - Pregnant or breast-feeding women - Treatment with an investigational agent or device within 30 days before screening or scheduled to receive an investigational agent other than those specified by this protocol during the course of this study - Known sensitivity to any of the products to be administered during dosing - Disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00116701
20040218
Not Provided
Global Development Leader, Amgen Inc.
Amgen
Not Provided
Study Director: MD Amgen
Amgen
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP