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WithdrawnNCT01428154Updated Jun 17, 2016

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

A Phase 1 interventional study of Darbepoetin alfa in Anemia and Chronic Kidney Disease, sponsored by Amgen. Withdrawn. Open to participants aged Up to 1 Year. Per ClinicalTrials.gov, last updated 2016-06-17.

Sponsored by Amgen · Phase 1, Interventional, and Treatment

Why this study was withdrawn
Difficulty in recruitment. PDCO in the Day 30 summary report agrred to remove the PK study in children \<1 year of age.
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
Up to 1 Year
Sex
All
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Study 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.

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Conditions studied

  • Anemia
  • Chronic Kidney Disease

Keywords

  • paediatric
  • dialysis
  • CKD
  • pediatric
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In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

Browse Kidney Diseases studies →

Lead sponsor

Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.

Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 1 Year
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Darbepoetin alfa

    Drug: Darbepoetin alfa

Interventions

  • DrugDarbepoetin alfa

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

    Also known as: Aranesp

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What researchers measure

Primary outcomes

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

    Time frame: Assessed over 29 days

  2. Number of subjects with treatment-emergent adverse events

    Time frame: Assessed over 29 days

Secondary outcomes

  1. Maximum observed concentration (Cmax) of darbepoetin alfa

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

  2. 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

  3. Area under the concentration curve (AUC) of darbepoetin alfa

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

  4. Terminal half-life (t½) of darbepoetin alfa

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

  5. Clearance (CL) of darbepoetin alfa

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

  6. Change in reticulocytes

    Time frame: Assessed from baseline to day 8

  7. Change in reticulocytes

    Time frame: Assessed from baseline to day 29

  8. Change in hemoglobin concentration

    Time frame: Assessed from baseline to day 8

  9. Change in hemoglobin concentration

    Time frame: Assessed from baseline to day 29

  10. Change in iron

    Time frame: Assessed from baseline to day 29

  11. Change in ferritin

    Time frame: Assessed from baseline to day 29

  12. Change in transferrin saturation

    Time frame: Assessed from baseline to day 29

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Study locations

No study locations are listed for this record.

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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01428154
Lead sponsor
Amgen
Responsible party
Sponsor
First posted
Sep 2, 2011
Start date
Apr 2016
Primary completion
Nov 2016 (estimated)
Completion
Nov 2016 (estimated)
Last update
Jun 17, 2016

Study contacts

MD
study director · Amgen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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