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Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Subjects With Chronic Kidney Disease

This study has been terminated.
(Study Terminated; Commitment met per Regulatory Authorities.)
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00436748
First received: February 15, 2007
Last updated: September 26, 2014
Last verified: September 2014
  Purpose

The primary objectives of this study are the following:

  1. To test if the proportion of subjects achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa QW for treatment of anemia in pediatric subjects with chronic kidney disease receiving and not receiving dialysis, and
  2. To test if the proportion of subjects achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa Q2W for treatment of anemia in pediatric subjects with chronic kidney disease receiving and not receiving dialysis

Condition Intervention Phase
Anemia
Chronic Kidney Disease
Kidney Disease
Drug: darbepoetin alfa QW
Drug: darbepoetin alfa Q2W
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Center, Double-Blind, Randomized Study Evaluating De Novo Weekly and Once Every Two Week Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Subjects With Chronic Kidney Disease Receiving and Not Receiving Dialysis

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • To test if the proportion of subjects achieving a Hb value >/= 10.0 g/dL at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa QW for treatment of anemia in pediatric CKD subjects receiving [ Time Frame: Entire Study ] [ Designated as safety issue: No ]
  • To test if the proportion of subjects achieving a Hb value >/= 10.0 g/dL at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa Q2W for treatment of anemia in pediatric CKD subjects receivin [ Time Frame: Entire Study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the health-related quality of life in pediatric CKD subjects >/= 2 years old over the duration of the study in the QW and Q2W arms [ Time Frame: Entire Study ] [ Designated as safety issue: No ]
  • To obtain pharmacokinetic (PK) data in subjects < 6 years of age [ Time Frame: Entire Study ] [ Designated as safety issue: No ]
  • To assess the safety and tolerability of darbepoetin alfa administered QW and Q2W [ Time Frame: Entire Study ] [ Designated as safety issue: Yes ]
  • To estimate Hb values over the duration of the study in the QW and Q2W arms [ Time Frame: Entire Study ] [ Designated as safety issue: No ]
  • To estimate doses over the duration of the study in the QW and Q2W arms [ Time Frame: Entire Study ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: August 2008
Study Completion Date: April 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: darbepoetin alfa QW Drug: darbepoetin alfa QW
darbepoetin alfa QW 10, 20, 30, 40, 50, 60, 80, 100, 150, 200, or 300 mcg IV or SC
Experimental: darbepoetin alfa Q2W Drug: darbepoetin alfa Q2W
darbepoetin alfa Q2W 10, 20, 30, 40, 50, 60, 80, 100, 150, 200, or 300 mcg IV or SC

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current diagnosis of Chronic Kidney Disease, either receiving or not receiving dialysis
  • Anemic, with two consecutive screening hemoglobin values drawn at least 7 days apart < 11.0 g/dL
  • Transferrin saturation (Tsat) greater than or equal to 20%

Exclusion Criteria:

  • Any erythropoiesis stimulating agent (ESA) use within 12 weeks prior to randomization
  • other hematologic disorders
  • upper or lower GI bleeding within 6 months prior to randomization
  • uncontrolled hypertension
  • prior history (within 12 weeks prior to randomization) of acute myocardial ischemia, hospitalization for congestive heart failure, myocardial infarction, stroke or transient ischemic attack
  • prior history (within 6 months prior to randomization) of thromboembolism
  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: NCT00436748

  Show 67 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00436748     History of Changes
Other Study ID Numbers: 20050256
Study First Received: February 15, 2007
Last Updated: September 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Chronic Kidney Disease
Dialysis
Anemia
Nephrology
Pediatric
Hemodialysis
Peritoneal Dialysis
Chronic Renal Insufficiency

Additional relevant MeSH terms:
Kidney Diseases
Anemia
Renal Insufficiency, Chronic
Hematologic Diseases
Renal Insufficiency
Urologic Diseases
Darbepoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014