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

Amgen

Status and phase

Completed

Phase 3

Conditions

Kidney Disease

Treatments

Drug: Aranesp® (darbepoetin alfa)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00124098

20030112

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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