Darbepoetin Treatment of Anemia in Children With Chronic Renal Failure

NCT00213291 | Completed Phase 3

• 1 other identifier: 1000004731
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study to determine the safety and effectiveness of Darbepoetin (Aranesp) given every 14 to 28 days to treat low red blood cells in children with chronic kidney failure.

Conditions

Kidney Failure, Chronic

Keywords

chronic kidney failure; darbepoetin; pediatrics; anemia

Outcome Measures

Primary Outcomes (1)

• The safety of darbepoetin when administered at an increased dosing interval

  40 weeks

Secondary Outcomes (4)

• Safety and tolerability of darbepoetin

  40 weeks

• Proportion of subjects who receive red blood cell transfusions

  40 weeks

• Percentage of Hb data points that exceed upper target of 125 g/L

  16-36 weeks

• Incidence of anti-erythropoietin antibody formation

  40 weeks

Study Arms (1)

1

EXPERIMENTAL

Drug: darbepoetin alfa

Interventions

darbepoetin alfa DRUG

Darbepoetin alfa will be administered by SC/IV injection every 14-28 days. Patients starting on the 14 day dose regimen will receive two times their baseline weekly dose; patients on the 28 day schedule will receive four times their average weekly dose. The exception to a Q14 or Q28 dosing schedule will be for patients requiring 10 mcg every 10 days. These patients will go to 20 mcg Q21 days before extending to the Q28 day schedule. Naive patients will start on a dose of 0.9 mcg/kg every 14 days. Study subjects who are successfully treated for 12 weeks on the 14 day schedule may be enrolled in the 28 day schedule study.

1

Eligibility Criteria

• Age: 1 Day - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• diagnosis of chronic renal insufficiency or end stage renal disease (ESRD) requiring dialysis
• clinically stable
• hemoglobin of 110-125 g/L in screening period; for naive subjects, hemoglobin \< 110 g/L
• not iron deficient (TSAT \> 19.5%) within 4 weeks of study entry
• stable darbepoetin alpha therapy administered IV or SC q7 to q21 days OR darbepoetin alpha naive
• written informed consent from parent/legal guardian
• less than 18 years old
• weight at least 10 kg
• females of childbearing potential must practice adequate contraception
• availability for follow-up assessments

You may not qualify if:

• scheduled for a living donor kidney transplant within 12 weeks of signing consent
• uncontrolled blood pressure as judged by principal investigator
• change in seizure pattern in past 30 days; grand-mal seizure 12 weeks before enrollment
• current clinical evidence of severe hyperparathyroidism
• major surgery 2 weeks before signing consent
• active inflammatory disease or condition requiring immunosuppressive therapy
• currently receiving antibiotics for active systemic infection
• peritoneal dialysis patient with an episode of peritonitis within the past 30 days
• known HIV antibody positivity
• known antibodies to rHuEPO
• known aluminum toxicity
• known red cell aplasia
• known malignancy

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Anemia

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; 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; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Denis F Geary, MD

  The Hospital For Sick Children, Toronto Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrologist

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: April 1, 2005
• Primary Completion: September 1, 2005
• Study Completion: October 1, 2005
• Last Updated: August 26, 2013

Record last verified: 2013-08

Locations

CA (1)