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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01428154
First received: September 1, 2011
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Anemia
Chronic Kidney Disease
Drug: Darbepoetin alfa
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Number of subjects with clinically significant changes in physical examinations, laboratory safety tests, and vital signs [ Time Frame: Assessed over 29 days ] [ Designated as safety issue: Yes ]
  • Number of subjects with treatment-emergent adverse events [ Time Frame: Assessed over 29 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Maximum observed concentration (Cmax) of darbepoetin alfa [ Time Frame: Assessed predose and at 6, 24, 48, 72, and 168 hours postdose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Area under the concentration curve (AUC) of darbepoetin alfa [ Time Frame: Assessed predose and at 6, 24, 48, 72, and 168 hours postdose ] [ Designated as safety issue: No ]
  • Terminal half-life (t½) of darbepoetin alfa [ Time Frame: Assessed predose and at 6, 24, 48, 72, and 168 hours postdose ] [ Designated as safety issue: No ]
  • Clearance (CL) of darbepoetin alfa [ Time Frame: Assessed predose and at 6, 24, 48, 72, and 168 hours postdose ] [ Designated as safety issue: No ]
  • Change in reticulocytes [ Time Frame: Assessed from baseline to day 8 ] [ Designated as safety issue: No ]
  • Change in reticulocytes [ Time Frame: Assessed from baseline to day 29 ] [ Designated as safety issue: No ]
  • Change in hemoglobin concentration [ Time Frame: Assessed from baseline to day 8 ] [ Designated as safety issue: No ]
  • Change in hemoglobin concentration [ Time Frame: Assessed from baseline to day 29 ] [ Designated as safety issue: No ]
  • Change in iron [ Time Frame: Assessed from baseline to day 29 ] [ Designated as safety issue: No ]
  • Change in ferritin [ Time Frame: Assessed from baseline to day 29 ] [ Designated as safety issue: No ]
  • Change in transferrin saturation [ Time Frame: Assessed from baseline to day 29 ] [ Designated as safety issue: No ]

Estimated Enrollment: 5
Study Start Date: October 2014
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Darbepoetin alfa Drug: Darbepoetin alfa
A single 1.5 μg/kg subcutaneous (SC) dose administration on day 1
Other Name: Aranesp

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01428154

Contacts
Contact: Amgen Call Center 866-572-6436

Locations
Finland
Helsinki University Central Hospital Recruiting
Helsinki, Finland, 00290
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01428154     History of Changes
Other Study ID Numbers: 20090302
Study First Received: September 1, 2011
Last Updated: July 10, 2014
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Amgen:
paediatric
dialysis
CKD
pediatric

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 25, 2014