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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00124098
• Date of registration: 30/06/2005
• Primary sponsor: Amgen
• Public title: An Evaluation of Aranesp® in Subjects With Anaemic Chronic Kidney Disease (CKD)
• Scientific title: An Open-Label Study of Aranesp® (Darbepoetin Alfa) Administration Once Every Four Weeks in Anaemic Chronic Kidney Disease (CKD) Subjects
• Date of first enrolment: October 2003
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00124098
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Kidney Disease

Intervention(s)

Drug: Aranesp® (darbepoetin alfa)

Primary Outcome(s)

Haemoglobin level

Secondary Outcome(s)

Adverse events

Aranesp® doses

Blood pressure

Laboratory parameters

Secondary ID(s)

20030112

Source(s) of Monetary Support

Please refer to primary and secondary sponsors