A Multi-Center, Single Arm Study Evaluating De Novo Once Monthly (QM) Darbepoetin Alfa Dosing for the Correction of Anemia in Subjects with Chronic Kidney Disease (CKD) Not Receiving Dialysis
- Conditions
- Anemia in subjects with chronic kidney disease not receiving dialysis
- Registration Number
- EUCTR2006-003173-27-FR
- Lead Sponsor
- Amgen Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 155
= 18 years of age
Estimated GFR of = 15 mL/min/1.73 m2 - = 60 mL/min/1.73 m2 (MDRD equation)
Clinically stable, in the judgment of the investigator
The mean of 2 screening Hb values taken at least 7 days apart must be <11.0 g/dL
Adequate iron stores (serum ferritin > 100 µg/L)
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
ESA use within 12 weeks before enrollment
Uncontrolled hypertension defined as diastolic BP > 110 mm Hg or systolic BP >180 mm Hg
Acute myocardial ischemia; hospitalization for congestive heart failure, myocardial infarction, deep vein thrombosis, stroke or transient ischemic attack within 12 weeks before enrollment
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 chemotherapy/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 hematological disease (eg, 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 study
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
Grand mal seizure within 6 months before enrollment
Upper or lower GI bleeding within 6 months before enrollment
Currently receiving immunosuppressive therapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method