Study to Evaluate Darbepoetin alfa in Pediatric Subjects With Anemia Due to Chronic Kidney Disease

• Register: EUCTR
• Last refreshed on: 8 August 2022
• Main ID: EUCTR2011-002150-31-HU
• Date of registration: 04/09/2012
• Prospective Registration: Yes
• Primary sponsor: Amgen Inc
• Public title: Study to Evaluate Darbepoetin alfa in Pediatric Subjects With Anemia Due to Chronic Kidney Disease
• Scientific title: An Open-label, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Darbepoetin alfa in Paediatric Subjects From Birth to Less than 1 Year of Age With Anemia due to Chronic Kidney Disease
• Date of first enrolment: 25/10/2012
• Target sample size: 5
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-002150-31
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Finland, Hungary, Russian Federation

Contacts

• Name: IHQ Medical Info - Clinical Trials
• Affiliation: Amgen (EUROPE) GmbH

• Name: IHQ Medical Info - Clinical Trials
• Affiliation: Amgen (EUROPE) GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
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

Exclusion criteria:
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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Anaemia due to chronic kidney disease
MedDRA version: 15.0 Level: LLT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 15.0 Level: LLT Classification code 10002272 Term: Anemia System Organ Class: 10005329 - Blood and lymphatic system disorders

Intervention(s)

Product Name: darbepoetin alfa 25 micrograms solution for injection in vial
Product Code: Not applicable
Pharmaceutical Form: Solution for injection
INN or Proposed INN: DARBEPOETIN ALFA
CAS Number: 209810-58-2
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 25-

Primary Outcome(s)

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

Timepoint(s) of evaluation of this end point: AEs throughout the study
Physical examinations at screening, pre-dose and day 29
Laboratory safety tests at screening and at day 8 and day 29
Vital signs at screening, pre-dose and at day 8 and day 29

Primary end point(s): Subject incidence of treatment-emergent AEs, and clinically significant changes in physical examinations, laboratory safety tests, and vital signs.

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:
Pharmacokinetic profile
Pharmacodynamic profile
Change in iron, ferritin and transferrin saturation (TSAT)

Secondary Outcome(s)

Secondary end point(s): PK parameters (ie, Cmax, Tmax, AUC, t½, and CL)
PD parameters, including change in:
reticulocytes from baseline to day 8, and day 29
hemoglobin concentration from baseline to day 8, and day 29
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


PD parameters:
reticulocytes baseline, day 8, and day 29
hemoglobin concentration baseline, day 8, and day 29
iron, ferritin, and TSAT baseline and day 29

Secondary ID(s)

2011-002150-31-FI

20090302

Source(s) of Monetary Support

Amgen Inc

Ethics review

Status: Approved
Approval date: 04/10/2012
Contact:

Results

• Results available: Yes
• Date Posted: 20/05/2021
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-002150-31/results