Anemia caused by chronic kidney didease. MedDRA version: 6.1 Level: PT Classification code 10038444
Conditions
Sponsors
Amgen Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Treatment Period 1: 1. Diagnosis of CKD and receiving dialysis for at least 3 months prior to screening 2. = 18 years of age 3. Baseline Hb level = 10.0 g/dL and = 13.0 g/dL 4. Adequate iron stores (defined as serum ferritin =100 µg/L or transferrin saturation (TSAT) = 20%) 5. Stable IV (Epoetin alfa or beta) or SC rHuEPO (Epoetin beta) therapy 1, 2, or 3 times per week for at least 8 weeks before screening (stable is defined as 11.0 g/dL and = 13.0 g/dL at week 24 3. Stable QW dose of IV darbepoetin alfa during Evaluation Period 1 (weeks 21 to 24). A stable dose is defined as: a. no prescribed dose increases, prescribed dose reductions or withheld doses b. no more than 1 missed dose c. no changes to dose frequency or route of administration 4. Before any protocol specific procedure for Treatment Period 2 is performed, the appropriate written informed consent must be obtained (see Section 12.1) 5. Adequate iron stores (defined as serum ferritin = 100 µg/L or TSAT = 20%) at week 24 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: Treatment Period 1: 1. Received SC Epoetin alpha in the 12 months before screening 2. Uncontrolled hypertension (diastolic blood pressure > 100 mm Hg) 3. Prior history (within 12 weeks before enrolment) of cardiovascular events including: - acute myocardial ischemia - hospitalization for congestive heart failure - myocardial infarction · 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 screening or scheduled to receive an investigational agent other than those specified by this protocol during the course of this study. · Known sensitivity to any of the products to be administered during dosing. · Disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures. Treatment Period 2: 1. Uncontrolled hypertension (diastolic blood pressure > 100 mmHg or systolic blood pressure > 180 mmHg) on 2 separate occasions during Evaluation Period 1 (weeks 21 to 24) 2. Received a red blood cell transfusion during study weeks 16 to 24
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Treatment Period 1: To demonstrate that haemoglobin (Hb) levels can be maintained or increased after switching HD subjects from either subcutaneous (SC) or intravenous (IV) rHuEPO to IV darbepoetin alfa. Treatment Period 2: To demonstrate that switching subjects with a Hb > 11 g/dL and = 13 g/dL from once weekly IV darbepoetin alfa to once every 2 weeks (Q2W) maintains the mean Hb at > 11 g/dL.;Secondary Objective: Treatment Period 1: · To evaluate the overall proportion of subjects achieving treatment targets for haemoglobin · To evaluate the proportion of subjects achieving treatment targets for haemoglobin in the sub-group of patients with a baseline Hb level = 11.0g/dL. · To assess the safety of switching patients to IV darbepoetin alfa by measurement of adverse events and laboratory parameters. Treatment Period 2: • To determine the proportion of subjects with a mean Hb > 11 g/dL • To determine the mean change in Hb between Evaluation Period 1 (weeks 21 to 4) and Evaluation Period 2 (weeks 45 to 48) • To determine the proportion of subjects with a mean Hb level maintained within -1.0 to +1.5 g/dL of the Hb in Evaluation Period 1 • To assess the safety of darbepoetin alfa once every two weeks by measurement of adverse events and laboratory parameters;Primary end point(s): Primary Efficacy Endpoint Treatment Period 1: • Mean Hb during the evaluation period (weeks 21-24) Treatment Period 2: • Mean Hb level during Evaluation Period 2 (weeks 45-48) Secondary Efficacy Endpoints Treatment Period 1: • The proportion of subjects with a mean Hb > 11.0 g/dL during the evaluation period • Change in Hb between screening/baseline and the evaluation period • Dose and frequency of darbepoetin alfa administration during the treatment period Treatment Period 2: • The proportion of subjects with a mean Hb > 11.0 g/dL during Evaluation Period 2 • Change in Hb between Evaluation Period 1 (as baseline for Treatment Period 2) and Evaluation Period 2 | — |
Countries
Czech Republic, Hungary
Outcome results
None listed