Study to Evaluate Darbepoetin alfa in Pediatric Subjects With Anemia Due to Chronic Kidney Disease
- Conditions
- Anaemia due to chronic kidney diseaseMedDRA version: 15.0Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disordersMedDRA version: 15.0Level: LLTClassification code 10002272Term: AnemiaSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2011-002150-31-HU
- Lead Sponsor
- Amgen Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
Girls and boys between birth and < 1 year of age at the time of enrollment
Body weight = 3 kg at screening and enrollment
Diagnosis of CKD stage 3 to 5 with an estimated GFR < 60 mL/min/1.73m2 without dialysis using the updated Schwartz Equation at screening; OR on dialysis at screening
Hemoglobin = 9.0 g/dL within 7 days prior to enrollment
Transferrin saturation (TSAT) = 20% at screening
Clinically stable and suitable for participation in this study, in the judgment of the Investigator
Subject’s parent or legally acceptable representative (SPoLAR) has provided informed consent prior to performing any study-specific procedures
Are the trial subjects under 18? yes
Number of subjects for this age range: 5
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Premature girls and boys (< 37 weeks of gestation, counting from the first day of the mother’s last menstrual period)
Peritoneal dialysis subjects with an episode of peritonitis within 30 days prior to enrollment
History of cardiovascular events or thromboembolism
History of upper or lower GI bleeding
History of seizures
Active liver disease or history of liver disease
Uncontrolled hypertension defined as stage 2 hypertension or greater. This is defined as a systolic or diastolic blood pressure value greater than the
99th percentile + 5 mmHg for a subject’s age. Refer to Blood Pressure Stages defined in the The Fourth Report on the Diagnosis, Evaluation, and Treatment of
High Blood Pressure in Children and Adolescents” Pediatrics 2004
Major surgery 12 weeks prior to enrollment
Red blood cell transfusions 12 weeks prior to enrollment
Use of any erythropoiesis-stimulating agent within 12 weeks prior to enrollment
Currently receiving antibiotic therapy for systemic infection within 4 weeks prior to enrollment
Current or prior use of immunosuppressants (excluding low-dose corticosteroids, defined as = 0.5 mg/kg per day prednisone or equivalent for = 5 days)
Subject is receiving a dose higher than 0.5 mg/kg per day of prednisone (or equivalent dose of another corticosteroid) for > 5 days within 4 weeks prior to
enrollment
Receiving or has received any investigational drug (or is currently using an investigational device) within the 30 days or 5 half-lives (whichever is longer) prior to enrollment
Subject has known hypersensitivity to darbepoetin alfa, r-HuEPO, or to any of the excipients
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety and tolerability of darbepoetin alfa following single 1.5 microgram/kg subcutaneous (SC) dose administration in paediatric subjects < 1 year of age with anaemia due to chronic kidney disease;Secondary Objective: Following single 1.5 microgram/kg subcutaneous (SC) dose administration in paediatric subjects < 1 year of age with anaemia due to chronic kidney disease, evaluate the:<br>Pharmacokinetic profile<br>Pharmacodynamic profile<br>Change in iron, ferritin and transferrin saturation (TSAT);Primary end point(s): Subject incidence of treatment-emergent AEs, and clinically significant changes in physical examinations, laboratory safety tests, and vital signs.;Timepoint(s) of evaluation of this end point: AEs throughout the study<br>Physical examinations at screening, pre-dose and day 29<br>Laboratory safety tests at screening and at day 8 and day 29<br>Vital signs at screening, pre-dose and at day 8 and day 29<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): PK parameters (ie, Cmax, Tmax, AUC, t½, and CL)<br>PD parameters, including change in:<br>reticulocytes from baseline to day 8, and day 29<br>hemoglobin concentration from baseline to day 8, and day 29<br>iron, ferritin, and TSAT from baseline to day 29;Timepoint(s) of evaluation of this end point: PK parameters: days 1, 2, 3, 4 and 8<br><br><br>PD parameters:<br>reticulocytes baseline, day 8, and day 29<br>hemoglobin concentration baseline, day 8, and day 29<br>iron, ferritin, and TSAT baseline and day 29