Clinical trial NCT00124098: An Evaluation of Aranesp® in Subjects With Anaemic Chronic Kidney Disease (CKD)
Official title: An Open-Label Study of Aranesp® (Darbepoetin Alfa) Administration Once Every Four Weeks in Anaemic Chronic Kidney Disease (CKD) Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Disease
Keywords: Chronic Kidney Disease (CKD)
anemia, clinical trial
darbepoetin alfa
Aranesp®
Amgen
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-07-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Haemoglobin level
Secondary outcomes:
measure: Aranesp® doses
measure: Adverse events
measure: Laboratory parameters
measure: Blood pressure
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Disney A, Jersey PD, Kirkland G, Mantha M, Charlesworth JA, Gallagher M, Harris D, Gock H, Mangos GJ, Macmillan J, Liu W, Viswalingam A. Darbepoetin alfa administered monthly maintains haemoglobin concentrations in patients with chronic kidney disease not receiving dialysis: a multicentre, open-label, Australian study. Nephrology (Carlton). 2007 Feb;12(1):95-101. doi: 10.1111/j.1440-1797.2006.00757.x.