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

NCT01428154 | Withdrawn Phase 1

• 1 other identifier: 20090302
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anemia; Chronic Kidney Disease

Keywords

paediatric; dialysis; CKD; pediatric

Outcome Measures

Primary Outcomes (2)

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

  Assessed over 29 days

• Number of subjects with treatment-emergent adverse events

  Assessed over 29 days

Secondary Outcomes (12)

• Maximum observed concentration (Cmax) of darbepoetin alfa

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

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

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

• Area under the concentration curve (AUC) of darbepoetin alfa

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

• Terminal half-life (t½) of darbepoetin alfa

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

• Clearance (CL) of darbepoetin alfa

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

Study Arms (1)

Darbepoetin alfa

EXPERIMENTAL

Drug: Darbepoetin alfa

Interventions

Darbepoetin alfa DRUG

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

Also known as: Aranesp

Darbepoetin alfa

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2011
• First Posted: September 2, 2011
• Study Start: April 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: June 17, 2016

Record last verified: 2016-06