Darbepoetin Treatment of Anemia in Children With Chronic Renal Failure

This study is currently recruiting participants.

Verified by The Hospital for Sick Children, September 2006

First Received: September 13, 2005 Last Updated: September 7, 2006 History of Changes

Sponsors and Collaborators:	The Hospital for Sick Children no other collaborators
Information provided by:	The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT00213291

Purpose

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

Condition	Intervention	Phase
Kidney Failure, Chronic	Drug: darbepoetin alfa	Phase II

MedlinePlus related topics: Anemia Kidney Failure

Drug Information available for: Darbepoetin alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Extended Dosing of Darbepoetin Alfa (Aranesp) for the Management of Anemia in Children With Chronic Renal Failure

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:

the safety of darbepoetin when administered at an increased dosing interval

Secondary Outcome Measures:

safety and tolerability of darbepoetin
proportion of subjects who receive red blood cell transfusions
percentage of Hb data points that exceed upper target of 125 g/L
incidence of anti-erythropoietin antibody formation

Estimated Enrollment:	40
Study Start Date:	April 2005

Eligibility

Ages Eligible for Study:	up to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00213291

Contacts

Contact: Denis F Geary, MD

416-813-6283

denis.geary@sickkids.ca

Locations

Canada, Ontario
The Hospital for Sick Children	Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Denis F Geary, MD 416-813-6283 denis.geary@sickkids.ca
Principal Investigator: Denis F Geary, MD
Sub-Investigator: Diane Hebert, MD
Sub-Investigator: Derek Stephens, MSc

Sponsors and Collaborators

The Hospital for Sick Children

no other collaborators

Investigators

Principal Investigator:

Denis F Geary, MD

The Hospital For Sick Children, Toronto Canada

More Information

No publications provided

Study ID Numbers:	1000004731
Study First Received:	September 13, 2005
Last Updated:	September 7, 2006
ClinicalTrials.gov Identifier:	NCT00213291 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by The Hospital for Sick Children:

chronic kidney failure
darbepoetin
pediatrics
anemia

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Hematinics
Renal Insufficiency, Chronic
Darbepoetin alfa

Anemia
Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Renal Insufficiency
Urologic Diseases
Hematinics
Renal Insufficiency, Chronic
Therapeutic Uses
Hematologic Agents

Darbepoetin alfa
Kidney Failure, Chronic
Kidney Diseases
Pharmacologic Actions
Kidney Failure

ClinicalTrials.gov processed this record on May 07, 2009