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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Kidney Disease
 Drug: Aranesp®
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Treatment period 1: Mean haemoglobin during the evaluation period (weeks 21-24)
  • Treatment period 2: Mean haemoglobin during evaluation period 2 (weeks 45-48)

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 200
Study Start Date: May 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00116701

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site
Notice regarding posted summaries of trial results  This link exits the ClinicalTrials.gov site
To access clinical trial results information click on this link  This link exits the ClinicalTrials.gov site
FDA-approved Drug Labeling  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00116701     History of Changes
Other Study ID Numbers: 20040218
Study First Received: June 30, 2005
Last Updated: May 1, 2008
Health Authority: Hungary: National Institute of Pharmacy

Keywords provided by Amgen:
Chronic Kidney Disease (CKD)
Haemoglobin (Hb)
Erthropoetin (EPO)
End Stage Renal Disease (ESRD)
Recombinant Human Erthropoetic (rHuEPO)
 Anaemia
Darbepoetin Alfa, Aranesp®
Haemodialysis
Clinical Trial

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
 Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013