Anemia in subjects with chronic kidney disease not receiving dialysis
Conditions
Interventions
Product Name: Darbepoetin alfa 10 micrograms solution for injection in a pre-filled pen
Pharmaceutical Form: Solution for injection
INN or Proposed INN: darbepoetin alfa
Concentration unit: µg/ml micr
Sponsors
Amgen Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: = 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 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the proportion of subjects achieving a Hb = 11.0 g/ dL at any time-point during the study following de novo QM darbepoetin alfa administration.;Secondary Objective: Secondary: • To determine Hb values over the duration of the study • To assess the proportion of subjects achieving a mean Hb = 11.0 g/dL during the evaluation period (weeks 25-33) • To determine QM darbepoetin alfa doses over the duration of the study • To assess the safety of darbepoetin alfa administered de novo QM • To assess the change in health related quality of life (HRQOL) scores between baseline, week 17 and end of study;Primary end point(s): Primary Efficacy Endpoint: Achievement of a Hb = 11.0 g/dL at any time point following de novo QM darbepoetin alfa administration. Secondary Efficacy Endpoints • Hb at each scheduled time-point (Baseline, weeks 3, 5, 7, 9, 11,13, 15, 17, 19, 21, 23, 25, 27, 29, 31 and 33) • QM Darbepoetin alfa doses over the duration of the study • Time to first Hb = 11.0 g/dL following de novo QM darbepoetin alfa administration • QM dose at first Hb = 11.0 g/dL following de novo QM darbepoetin alfa administration • Achievement of a mean Hb during the evaluation period = 11.0 g/dL Safety Endpoints • Maximum Hb increase over a 2 week period following de novo QM darbepoetin alfa administration • Adverse events following de novo QM darbepoetin alfa administration • Laboratory parameters and blood pressure at each scheduled time point • Hb ROR and excursions above 14.0 g/dL following de novo QM darbepoetin alfa administration • Anti-erythropoietic protein antibodies HRQOL Endpoint Change in HRQOL scores (SF-36 and EQ-5D) from baseline to week 17 and end of study | — |
Countries
Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Italy, Latvia, Poland, Portugal, Slovakia, Slovenia, Spain, United Kingdom
Outcome results
None listed