A Randomized, Double-Blind, Equivalence Study of the Efficacy of Darbepoetin Alfa Manufactured by Serum Free Bioreactor Technology and Darbepoetin Alfa Manufactured by Roller-Bottle Technology for the Treatment of Anemia in Patients with Chronic Kidney Disease Receiving Hemodialysis
- Conditions
- Chronic kidney diseaseMedDRA version: 6.1Level: LLT Classification code 10038444
- Registration Number
- EUCTR2004-004178-10-ES
- Lead Sponsor
- Amgen Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 420
· =18 years of age.
· Diagnosis of CKD and receiving hemodialysis for = 3 months before enrollment
· No prior exposure to EPREX or NeoRecorman.
· Baseline Hb between 10 and 13 g/dL
· On stable weekly or once every other week IV or SC Aranesp therapy for at least 6 weeks prior to screening (stable is defined as < 25% change in weekly dose and no change in frequency)
· Adequate iron stores (serum ferritin = 100 µg/L)
· Before any study-specific procedure, the appropriate written informed consent must be obtained
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
· Scheduled to receive a kidney transplant.
· Uncontrolled hypertension, defined as a pre-dialysis systolic BP > 180 and/or diastolic BP of > 110.
· Acute myocardial ischemia; hospitalization for congestive heart failure or myocardial infarction within 12 weeks before enrollment.
· Parathyroid hormone (PTH) level > 1500 pg/mL
· Major surgery within 12 weeks before enrollment (excluding vascular access surgery).
· Currently receiving antibiotic therapy for systemic infection.
· Known positive HIV antibody or positive hepatitis B surface antigen.
· Clinical evidence of current malignancy and/or receiving systemic hemotherapy/radiotherapy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia.
· Red blood cell (RBC) transfusions within 8 weeks before enrollment.
· Androgen therapy within 8 weeks before enrollment.
· Systemic hematologic disease (e.g., sickle cell anemia, myelodysplastic syndromes, hematologic malignancy; myeloma; hemolytic anemia).
· Any disorder that 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) throughout this trial.
· Treatment with an investigational agent or device within 30 days before enrollment or scheduled to receive an investigational agent other than those specified by this protocol during the course of this study.
· Subject has known sensitivity to any of the products to be administered during dosing.
· Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate whether the efficacy of darbepoetin alfa manufactured by serum free bioreactor Technology is equivalent to that of darbepoetin alfa manufactured by roller bottle technology for the treatment of anemia in patients with CKD receiving dialysis.;Secondary Objective: To evaluate whether the safety and tolerability of darbepoetin alfa SF is similar to that of darbepoetin alfa RB for the treatment of anemia in patients with CKD receiving dialysis.;Primary end point(s): • Change in Hb level between the baseline period and the evaluation period<br>• The ratio of weekly dosing requirements between baseline and the evaluation period.
- Secondary Outcome Measures
Name Time Method