An Evaluation of Aranesp® in Subjects With Anaemic Chronic Kidney Disease (CKD)

June 13, 2008 updated by: Amgen

An Open-Label Study of Aranesp® (Darbepoetin Alfa) Administration Once Every Four Weeks in Anaemic Chronic Kidney Disease (CKD) Subjects

The purpose of this study is to assess if Aranesp® administered once every 4 weeks to chronic kidney disease subjects is safe and efficacious in maintaining haemoglobin levels greater than or equal to 100 g/L.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of chronic kidney disease and not expected to initiate dialysis for the duration of the study

  • Creatinine clearance greater than 15 and less than 40 mL/min as estimated by the Cockroft-Gault equation:

    • Creatinine Clearance = (140-age in years) x body weight in kg/serum creatinine (mg/dL) x 72.
    • For women, the value will be multiplied by 0.85
  • Receiving stable every other week subcutaneous doses of Aranesp®.

  • A stable dose is defined as less than or equal to 25% change in Aranesp® dose over the 6-week period immediately prior to enrollment and with no more than

    1 missed dose over this period

  • At least two haemoglobin values within the target range of 100 to 130 g/L obtained at least 1 week apart and within 5 weeks of the baseline visit
  • Subjects must have a haemoglobin of 100 to 130 g/L at eligibility/baseline
  • Serum ferritin greater than or equal to 100 mg/L or transferrin saturation greater than or equal to 19.5%
  • Serum vitamin B12 and folate levels must be above the lower limit of the normal range of the local laboratory
  • Before any study specific procedure is performed, the subject must provide informed consent for participation in the study

Exclusion Criteria:

  • Anticipating, scheduled for, or a prior recipient of a kidney transplant
  • Uncontrolled hypertension (blood pressure greater than 160/100 mmHg during the eligibility/baseline period on 2 separate measurements)
  • Congestive heart failure (New York Heart Association [NYHA] class III or IV)
  • Clinical evidence of severe hyperparathyroidism (parathyroid hormone level greater than 1500 pg/mL or biopsy-proven bone marrow fibrosis)
  • Major surgery within 12 weeks before enrollment (excluding vascular access surgery)
  • Active chronic inflammatory process
  • Currently receiving antibiotic therapy for systemic infection
  • ALT or AST greater than 2 times the upper limit of normal range
  • Known positive HIV antibody or positive hepatitis B surface antigen
  • Clinical evidence of current malignancy and/or receiving systemic chemotherapy/radiotherapy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia
  • Red blood cell transfusions within 8 weeks before eligibility visit or active bleeding
  • Systemic hematologic disease (e.g., sickle cell anaemia, myelodysplastic syndromes, hematologic malignancy, myeloma, haemolytic anaemia)
  • Psychiatric or any other disorder which may impact (in the judgment of the Investigator) the ability to give informed consent for participation in this study
  • Pregnant or breast feeding women
  • All subjects must practice adequate contraception in the judgment of the Investigator, during the course of their participation in the trial
  • Previous entry in this study
  • Treatment with an investigational agent other than Aranesp® or device within 30 days before the first dose of study drug or scheduled to receive an investigational agent other than those specified by this protocol during the course of this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Haemoglobin level

Secondary Outcome Measures

Outcome Measure
Adverse events
Blood pressure
Laboratory parameters
Aranesp® doses

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

June 30, 2005

First Submitted That Met QC Criteria

July 25, 2005

First Posted (ESTIMATE)

July 27, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

June 16, 2008

Last Update Submitted That Met QC Criteria

June 13, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20030112

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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