Darbepoetin Treatment of Anemia in Children With Chronic Renal Failure - Full Text View

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 3


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Extended Dosing of Darbepoetin Alfa (Aranesp) for the Management of Anemia in Children With Chronic Renal Failure

Resource links provided by NLM:

MedlinePlus related topics: Anemia Kidney Failure

Drug Information available for: Darbepoetin Alfa

U.S. FDA Resources

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 [ Time Frame: 40 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Safety and tolerability of darbepoetin [ Time Frame: 40 weeks ] [ Designated as safety issue: Yes ]
Proportion of subjects who receive red blood cell transfusions [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]
Percentage of Hb data points that exceed upper target of 125 g/L [ Time Frame: 16-36 weeks ] [ Designated as safety issue: No ]
Incidence of anti-erythropoietin antibody formation [ Time Frame: 40 weeks ] [ Designated as safety issue: No ]


Estimated Enrollment:	40
Study Start Date:	April 2005
Estimated Study Completion Date:	October 2005
Primary Completion Date:	September 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: darbepoetin alfa 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.

Arms

Assigned Interventions

Experimental: 1

Drug: darbepoetin alfa

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.

Detailed Description:

Erythropoietin (EPO) is a glycoprotein synthesized in the kidneys which regulates the rate of proliferation and differentiation of red blood cell precursors. The main cause of anemia in children with chronic renal failure is deficiency of EPO production as a result of declining renal function. Recombinant human EPO (rHuEPO) is a synthetic erythropoietin that is structurally and functionally similar to naturally occuring EPO. Treatment of anemia using rHuEPO has been associated with an improvement in the quality of life for patients, likely attributable to an increased production in hemoglobin and a reduction of dilatation of the heart. Recently, an analogue of EPO with two extra oligosaccharide chins, darbepoetin alfa, has been described as having a more prolonged effect requiring less frequent dosing.

There are currently no data available on the efficacy of darbepoetin alfa administered every 14-28 days for children. The most common dosing schedules in the clinical trial at HSC are every 7, 10, and 14 days. Due to reports of increased pain associated with the SC injection, and confusion of caregivers when the 10 day dosing schedule is necessary, the goals of the current proposal are to: 1) Decrease the frequency of SC injections and 2)Eliminate the 10 day dosing schedule for the administration of Darbepoetin.

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

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: NCT00213291

Locations


Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8

Sponsors and Collaborators

The Hospital for Sick Children

Investigators


Principal Investigator:	Denis F Geary, MD	The Hospital For Sick Children, Toronto Canada

More Information

No publications provided


Responsible Party:	Denis Geary, Nephrologist, The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT00213291 History of Changes
Other Study ID Numbers:	1000004731
Study First Received:	September 13, 2005
Last Updated:	August 23, 2013
Health Authority:	Canada: Health Canada

Keywords provided by The Hospital for Sick Children:


chronic kidney failure darbepoetin pediatrics anemia

Additional relevant MeSH terms:


Kidney Failure, Chronic Kidney Diseases Renal Insufficiency Renal Insufficiency, Chronic Urologic Diseases	Darbepoetin alfa Hematinics Hematologic Agents Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015