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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002150-31-FI

Enrollment

Registered

2012-07-25

Start date

2012-08-29

Completion date

Unknown

Last updated

2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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: 2

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Girls and boys between birth and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Premature girls and boys ( 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

Design outcomes

Primary

Measure	Time frame
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: Pharmacokinetic profile Pharmacodynamic profile 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 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	—

Measure

Time frame

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: Pharmacokinetic profile Pharmacodynamic profile 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 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

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Finland, Hungary, Russian Federation

Contacts

Public ContactIHQ Medical Info - Clinical Trials

Amgen (EUROPE) GmbH

MedinfoInternational@amgen.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026