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

Primary Purpose

Anemia, Chronic Kidney Disease

Status

Withdrawn

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Darbepoetin alfa

About this trial

This is an interventional treatment trial for Anemia focused on measuring paediatric, dialysis, CKD, pediatric

Eligibility Criteria

undefined - 1 Year (Child)All SexesDoes not accept healthy volunteers

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 chronic kidney disease stage 3 to 5 with an estimated Glomerular Filtration Rate < 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 ≥ 20% at screening

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 gastrointestinal 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
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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Darbepoetin alfa

Arm Description

Outcomes

Primary Outcome Measures

Number of subjects with clinically significant changes in physical examinations, laboratory safety tests, and vital signs

Number of subjects with treatment-emergent adverse events

Secondary Outcome Measures

Maximum observed concentration (Cmax) of darbepoetin alfa

Time at which maximum concentration is observed (Tmax) of darbepoetin alfa

Area under the concentration curve (AUC) of darbepoetin alfa

Terminal half-life (t½) of darbepoetin alfa

Clearance (CL) of darbepoetin alfa

Change in reticulocytes

Change in hemoglobin concentration

Change in iron

Change in ferritin

Change in transferrin saturation

Full Information

NCT ID

NCT01428154

First Posted

September 1, 2011

Last Updated

June 16, 2016

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT01428154

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Withdrawn

Why Stopped

Difficulty in recruitment. PDCO in the Day 30 summary report agrred to remove the PK study in children <1 year of age.

Study Start Date

April 2016 (undefined)

Primary Completion Date

November 2016 (Anticipated)

Study Completion Date

November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to find out more about darbepoetin alfa in children less than 1 year of age with anemia (a decrease in red blood cells) due to kidney failure. This study will see if darbepoetin alfa is safe and well tolerated and whether it causes any side effects by taking blood samples and checking vital signs (heart rate, body temperature, and blood pressure tests) at specific times throughout the study. In addition, the study will evaluate the amount of darbepoetin alfa in the blood over time and look at special markers in the blood to evaluate how darbepoetin alfa works on anemia. Darbepoetin alfa is approved by the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) for use in adults, but not for all ages of pediatric subjects. Therefore, studies need to be conducted in pediatric subjects (children) to determine the appropriate dose to use in younger children.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia, Chronic Kidney Disease

Keywords

paediatric, dialysis, CKD, pediatric

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Darbepoetin alfa

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Darbepoetin alfa

Other Intervention Name(s)

Aranesp

Intervention Description

A single 1.5 μg/kg subcutaneous (SC) dose administration on day 1

Primary Outcome Measure Information:

Title

Number of subjects with clinically significant changes in physical examinations, laboratory safety tests, and vital signs

Time Frame

Assessed over 29 days

Title

Number of subjects with treatment-emergent adverse events

Time Frame

Assessed over 29 days

Secondary Outcome Measure Information:

Title

Maximum observed concentration (Cmax) of darbepoetin alfa

Time Frame

Assessed predose and at 6, 24, 48, 72, and 168 hours postdose

Title

Time at which maximum concentration is observed (Tmax) of darbepoetin alfa

Time Frame

Assessed predose and at 6, 24, 48, 72, and 168 hours postdose

Title

Area under the concentration curve (AUC) of darbepoetin alfa

Time Frame

Assessed predose and at 6, 24, 48, 72, and 168 hours postdose

Title

Terminal half-life (t½) of darbepoetin alfa

Time Frame

Assessed predose and at 6, 24, 48, 72, and 168 hours postdose

Title

Clearance (CL) of darbepoetin alfa

Time Frame

Assessed predose and at 6, 24, 48, 72, and 168 hours postdose

Title

Change in reticulocytes

Time Frame

Assessed from baseline to day 8

Title

Change in reticulocytes

Time Frame

Assessed from baseline to day 29

Title

Change in hemoglobin concentration

Time Frame

Assessed from baseline to day 8

Title

Change in hemoglobin concentration

Time Frame

Assessed from baseline to day 29

Title

Change in iron

Time Frame

Assessed from baseline to day 29

Title

Change in ferritin

Time Frame

Assessed from baseline to day 29

Title

Change in transferrin saturation

Time Frame

Assessed from baseline to day 29

10. Eligibility

Sex

All

Maximum Age & Unit of Time

1 Year

Accepts Healthy Volunteers

Eligibility 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 chronic kidney disease stage 3 to 5 with an estimated Glomerular Filtration Rate < 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 ≥ 20% at screening 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 gastrointestinal 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

12. IPD Sharing Statement

Links:

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

Learn more about this trial

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

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