Clinical trial NCT00436748: Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Patients With Chronic Kidney Disease
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Anemia
Chronic Kidney Disease
Kidney Disease
Keywords: Chronic Kidney Disease
Dialysis
Anemia
Nephrology
Pediatric
Hemodialysis
Peritoneal Dialysis
Chronic Renal Insufficiency
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2007-02-19
Enrollment: 116
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objectives of this study are the following:

1. To test if the proportion of participants 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 once a week (QW) for treatment of anemia in pediatric patients with chronic kidney disease receiving and not receiving dialysis, and
2. To test if the proportion of participants 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 every 2 weeks (Q2W) for treatment of anemia in pediatric patients with chronic kidney disease receiving and not receiving dialysis.


Eligibility 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 gastrointenstinal 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

Primary outcomes:
measure: Proportion of Participants Achieving Hemoglobin ≥ 10.0 g/dL
timeFrame: 24 weeks
Secondary outcomes:
measure: Time to First Hemoglobin Value ≥ 10.0 g/dL
timeFrame: 24 weeks
measure: Hemoglobin Concentration Over Time
timeFrame: Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.
measure: Weight-adjusted Darbepoetin Alfa Dose at Time of Achieving First Hemoglobin ≥ 10.0 g/dL
timeFrame: 24 weeks
measure: Darbepoetin Alfa Weight-Adjusted Dose Over Time
timeFrame: Day 1 (initial dose) and Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.
measure: Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores
timeFrame: Baseline, Week 13 and Week 25 (or end of study visit if earlier than Week 25)
measure: Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores
timeFrame: Baseline, Week 13 and Week 25 (or end of study visit if earlier than Week 25)
measure: Number of Participants With Treatment-emergent Adverse Events
timeFrame: 25 weeks
measure: Hemoglobin Serial Rate of Change (ROC) Over Time
timeFrame: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.
measure: Number of Participants With Hemoglobin > 12.0, > 13.0, and > 14.0 g/dL During the Study
timeFrame: 25 weeks
measure: Maximum Increase in Hemoglobin Over Any 2 Week Period
timeFrame: 25 weeks
measure: Change From Baseline in Systolic Blood Pressure Over Time
timeFrame: Baseline and Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.
measure: Change From Baseline in Diastolic Blood Pressure Over Time
timeFrame: Baseline and Weeks 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 and 25.
measure: Number of Participants Who Developed Anti-erythropoiesis Antibodies
timeFrame: 25 weeks
measure: Darbepoetin Alfa Serum Concentrations for Participants Less Than 6 Years of Age
timeFrame: Weeks 1, 2, and 3 before the investigational product dose and 2 days after the first investigational product dose
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: San Francisco
country: United States
facility: Research Site
state: California
city: Stanford
country: United States
facility: Research Site
state: California
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Gainesville
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Boise
country: United States
facility: Research Site
state: Idaho
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Iowa City
country: United States
facility: Research Site
state: Iowa
city: Louisville
country: United States
facility: Research Site
state: Kentucky
city: New Orleans
country: United States
facility: Research Site
state: Louisiana
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Kansas City
country: United States
facility: Research Site
state: Missouri
city: Livingston
country: United States
facility: Research Site
state: New Jersey
city: New Brunswick
country: United States
facility: Research Site
state: New Jersey
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Bronx
country: United States
facility: Research Site
state: New York
city: Buffalo
country: United States
facility: Research Site
state: New York
city: New Hyde Park
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Valhalla
country: United States
facility: Research Site
state: New York
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Akron
country: United States
facility: Research Site
state: Ohio
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Charlottesville
country: United States
facility: Research Site
state: Virginia
city: Norfolk
country: United States
facility: Research Site
state: Virginia
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Edegem
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Jurmala
country: Latvia
facility: Research Site
city: Vilnius
country: Lithuania
facility: Research Site
city: Mexico
country: Mexico
facility: Research Site
state: Distrito Federal
city: Aguascalientes
country: Mexico
facility: Research Site
city: Chihuahua
country: Mexico
facility: Research Site
city: Puebla
country: Mexico
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Szczecin
country: Poland
facility: Research Site
city: San Juan
country: Puerto Rico
facility: Research Site
city: Krasnodar
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Orenburg
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Samara
country: Russian Federation
facility: Research Site
city: Banska Bystrica
country: Slovakia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Leeds
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Warady BA, Barcia J, Benador N, Jankauskiene A, Olson K, Podracka L, Shavkin A, Srivaths P, Wong CJ, Petersen J. De novo weekly and biweekly darbepoetin alfa dosing in pediatric patients with chronic kidney disease. Pediatr Nephrol. 2018 Jan;33(1):125-137. doi: 10.1007/s00467-017-3758-5. Epub 2017 Aug 17.