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

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

Sponsors

Lead Sponsor: Amgen

Source Amgen
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.

Overall Status Terminated
Start Date September 16, 2008
Completion Date March 3, 2014
Primary Completion Date March 3, 2014
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Proportion of Participants Achieving Hemoglobin ≥ 10.0 g/dL 24 weeks
Secondary Outcome
Measure Time Frame
Time to First Hemoglobin Value ≥ 10.0 g/dL 24 weeks
Hemoglobin Concentration Over Time 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.
Weight-adjusted Darbepoetin Alfa Dose at Time of Achieving First Hemoglobin ≥ 10.0 g/dL 24 weeks
Darbepoetin Alfa Weight-Adjusted Dose Over Time 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.
Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores Baseline, Week 13 and Week 25 (or end of study visit if earlier than Week 25)
Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores Baseline, Week 13 and Week 25 (or end of study visit if earlier than Week 25)
Number of Participants With Treatment-emergent Adverse Events 25 weeks
Hemoglobin Serial Rate of Change (ROC) Over Time 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.
Number of Participants With Hemoglobin > 12.0, > 13.0, and > 14.0 g/dL During the Study 25 weeks
Maximum Increase in Hemoglobin Over Any 2 Week Period 25 weeks
Change From Baseline in Systolic Blood Pressure Over Time 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.
Change From Baseline in Diastolic Blood Pressure Over Time 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.
Number of Participants Who Developed Anti-erythropoiesis Antibodies 25 weeks
Darbepoetin Alfa Serum Concentrations for Participants Less Than 6 Years of Age Weeks 1, 2, and 3 before the investigational product dose and 2 days after the first investigational product dose
Enrollment 116
Condition
Intervention

Intervention Type: Drug

Intervention Name: Darbepoetin Alfa

Description: Administered by subcutaneous or intravenous injection

Other Name: Aranesp®

Intervention Type: Drug

Intervention Name: Placebo

Description: Matching placebo solution for subcutaneous or intravenous injection to maintain the blind in the Q2W arm.

Arm Group Label: Darbepoetin Alfa Q2W

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

Gender: All

Minimum Age: 1 Year

Maximum Age: 18 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
MD Study Director Amgen
Location
Facility:
Research Site | Birmingham, Alabama, 35233, United States
Research Site | Los Angeles, California, 90027, United States
Research Site | Los Angeles, California, 90095, United States
Research Site | San Diego, California, 92123, United States
Research Site | San Francisco, California, 94143, United States
Research Site | Stanford, California, 94305-5208, United States
Research Site | Washington, District of Columbia, 20010, United States
Research Site | Gainesville, Florida, 32610, United States
Research Site | Miami, Florida, 33136, United States
Research Site | Orlando, Florida, 32806, United States
Research Site | Boise, Idaho, 83712, United States
Research Site | Chicago, Illinois, 60612, United States
Research Site | Iowa City, Iowa, 52242, United States
Research Site | Louisville, Kentucky, 40202, United States
Research Site | New Orleans, Louisiana, 70118, United States
Research Site | Baltimore, Maryland, 21287, United States
Research Site | Boston, Massachusetts, 02115, United States
Research Site | Kansas City, Missouri, 64108, United States
Research Site | Livingston, New Jersey, 07039, United States
Research Site | New Brunswick, New Jersey, 08901, United States
Research Site | Albuquerque, New Mexico, 87131, United States
Research Site | Bronx, New York, 10467, United States
Research Site | Buffalo, New York, 14222, United States
Research Site | New Hyde Park, New York, 11040, United States
Research Site | New York, New York, 10029, United States
Research Site | Valhalla, New York, 10595, United States
Research Site | Charlotte, North Carolina, 28203, United States
Research Site | Akron, Ohio, 44308, United States
Research Site | Cincinnati, Ohio, 45229, United States
Research Site | Cleveland, Ohio, 44106, United States
Research Site | Cleveland, Ohio, 44195, United States
Research Site | Columbus, Ohio, 43205, United States
Research Site | Portland, Oregon, 97227, United States
Research Site | Portland, Oregon, 97239, United States
Research Site | Philadelphia, Pennsylvania, 19104, United States
Research Site | Dallas, Texas, 75390, United States
Research Site | Houston, Texas, 77030, United States
Research Site | San Antonio, Texas, 78229, United States
Research Site | Charlottesville, Virginia, 22908, United States
Research Site | Norfolk, Virginia, 23507, United States
Research Site | Richmond, Virginia, 23219, United States
Research Site | Seattle, Washington, 98105, United States
Research Site | Edegem, 2650, Belgium
Research Site | Gent, 9000, Belgium
Research Site | Leuven, 3000, Belgium
Research Site | Jurmala, 2015, Latvia
Research Site | Vilnius, 08406, Lithuania
Research Site | Mexico, Distrito Federal, 06720, Mexico
Research Site | Aguascalientes, 20230, Mexico
Research Site | Chihuahua, 31000, Mexico
Research Site | Puebla, 72190, Mexico
Research Site | Gdansk, 80-952, Poland
Research Site | Lodz, 93-338, Poland
Research Site | Szczecin, 70-410, Poland
Research Site | San Juan, 00935, Puerto Rico
Research Site | Krasnodar, 350033, Russian Federation
Research Site | Moscow, 107014, Russian Federation
Research Site | Moscow, 117997, Russian Federation
Research Site | Orenburg, 460004, Russian Federation
Research Site | Saint Petersburg, 198205, Russian Federation
Research Site | Samara, 443095, Russian Federation
Research Site | Banska Bystrica, 974 09, Slovakia
Research Site | Bratislava, 833 40, Slovakia
Research Site | Kosice, 040 11, Slovakia
Research Site | Birmingham, B4 6NH, United Kingdom
Research Site | Leeds, LS1 3EX, United Kingdom
Research Site | London, SE1 7EH, United Kingdom
Location Countries

Belgium

Latvia

Lithuania

Mexico

Poland

Puerto Rico

Russian Federation

Slovakia

United Kingdom

United States

Verification Date

January 2018

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Darbepoetin Alfa QW

Type: Experimental

Description: Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.

Label: Darbepoetin Alfa Q2W

Type: Experimental

Description: Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov