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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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8 August 2022 |
Main ID: |
EUCTR2011-002150-31-FI |
Date of registration:
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25/07/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Study to Evaluate Darbepoetin alfa in Pediatric Subjects With Anemia Due to Chronic Kidney Disease
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Scientific title:
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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:
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29/08/2012 |
Target sample size:
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5 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-002150-31 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no Randomised: no Open: no 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
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Phase:
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Human pharmacology (Phase I): yes
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Finland
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Hungary
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Russian Federation
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Contacts
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Name:
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IHQ Medical Info - Clinical Trials
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Address:
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Dammstrasse 23, P.O. Box 1557
(CH-)6300
Zug
Switzerland |
Telephone:
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Email:
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MedinfoInternational@amgen.com |
Affiliation:
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Amgen (EUROPE) GmbH |
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Name:
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IHQ Medical Info - Clinical Trials
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Address:
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Dammstrasse 23, P.O. Box 1557
(CH-)6300
Zug
Switzerland |
Telephone:
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Email:
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MedinfoInternational@amgen.com |
Affiliation:
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Amgen (EUROPE) GmbH |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
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Anaemia due to chronic kidney disease MedDRA version: 14.1
Level: LLT
Classification code 10064848
Term: Chronic kidney disease
System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 14.1
Level: LLT
Classification code 10002272
Term: Anemia
System Organ Class: 10005329 - Blood and lymphatic system disorders
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Intervention(s)
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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-
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Primary Outcome(s)
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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
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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
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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)
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Primary end point(s): Subject incidence of treatment-emergent AEs, and clinically significant changes in physical examinations, laboratory safety tests, and vital signs.
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Secondary Outcome(s)
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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
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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
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Source(s) of Monetary Support
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Amgen Inc
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Ethics review
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Status: Approved
Approval date: 29/08/2012
Contact:
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