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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00436748
Other study ID # 20050256
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date September 16, 2008
Est. completion date March 3, 2014

Study information

Verified date November 2022
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 116
Est. completion date March 3, 2014
Est. primary completion date March 3, 2014
Accepts healthy volunteers No
Gender All
Age group 1 Year to 18 Years
Eligibility 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

Study Design


Intervention

Drug:
Darbepoetin Alfa
Administered by subcutaneous or intravenous injection
Placebo
Matching placebo solution for subcutaneous or intravenous injection to maintain the blind in the Q2W arm.

Locations

Country Name City State
Belgium Research Site Edegem
Belgium Research Site Gent
Belgium Research Site Leuven
Latvia Research Site Jurmala
Lithuania Research Site Vilnius
Mexico Research Site Aguascalientes
Mexico Research Site Chihuahua
Mexico Research Site Mexico Distrito Federal
Mexico Research Site Puebla
Poland Research Site Gdansk
Poland Research Site Lodz
Poland Research Site Szczecin
Puerto Rico Research Site San Juan
Russian Federation Research Site Krasnodar
Russian Federation Research Site Moscow
Russian Federation Research Site Moscow
Russian Federation Research Site Orenburg
Russian Federation Research Site Saint Petersburg
Russian Federation Research Site Samara
Slovakia Research Site Banska Bystrica
Slovakia Research Site Bratislava
Slovakia Research Site Kosice
United Kingdom Research Site Birmingham
United Kingdom Research Site Leeds
United Kingdom Research Site London
United States Research Site Akron Ohio
United States Research Site Albuquerque New Mexico
United States Research Site Baltimore Maryland
United States Research Site Birmingham Alabama
United States Research Site Boise Idaho
United States Research Site Boston Massachusetts
United States Research Site Bronx New York
United States Research Site Buffalo New York
United States Research Site Charlotte North Carolina
United States Research Site Charlottesville Virginia
United States Research Site Chicago Illinois
United States Research Site Cincinnati Ohio
United States Research Site Cleveland Ohio
United States Research Site Cleveland Ohio
United States Research Site Columbus Ohio
United States Research Site Dallas Texas
United States Research Site Gainesville Florida
United States Research Site Houston Texas
United States Research Site Iowa City Iowa
United States Research Site Kansas City Missouri
United States Research Site Livingston New Jersey
United States Research Site Los Angeles California
United States Research Site Los Angeles California
United States Research Site Louisville Kentucky
United States Research Site Miami Florida
United States Research Site New Brunswick New Jersey
United States Research Site New Hyde Park New York
United States Research Site New Orleans Louisiana
United States Research Site New York New York
United States Research Site Norfolk Virginia
United States Research Site Orlando Florida
United States Research Site Philadelphia Pennsylvania
United States Research Site Portland Oregon
United States Research Site Portland Oregon
United States Research Site Richmond Virginia
United States Research Site San Antonio Texas
United States Research Site San Diego California
United States Research Site San Francisco California
United States Research Site Seattle Washington
United States Research Site Stanford California
United States Research Site Valhalla New York
United States Research Site Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Belgium,  Latvia,  Lithuania,  Mexico,  Poland,  Puerto Rico,  Russian Federation,  Slovakia,  United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of Participants Achieving Hemoglobin = 10.0 g/dL The proportion of participants achieving hemoglobin = 10.0 g/dL (the correction proportion) was calculated as the number of participants achieving a hemoglobin = 10.0 g/dL at any time point during the study when administered de novo darbepoetin alfa without receiving any red blood cell transfusion after randomization and within 90 days before the achievement, divided by the number of participants in the efficacy analysis set. 24 weeks
Secondary Time to First Hemoglobin Value = 10.0 g/dL The time from study Day 1 to the day a participant first achieved hemoglobin = 10.0 g/dL for participants who achieved hemoglobin = 10.0 g/dL. 24 weeks
Secondary 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.
Secondary Weight-adjusted Darbepoetin Alfa Dose at Time of Achieving First Hemoglobin = 10.0 g/dL The darbepoetin alfa dose at the time a participant achieved a first hemoglobin level = 10.0 g/dL, divided by the participant's weight measured at the closest study week prior to the dosing, post dialysis. 24 weeks
Secondary Darbepoetin Alfa Weight-Adjusted Dose Over Time Arithmetic means are provided; Withheld doses are counted as 0 µg. 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.
Secondary Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores The PedsQL is a health-related quality of life (HRQOL) questionnaire that can be used to measure quality of life in children = 2 years old. The 23-item PedsQL 4.0 includes physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), and school functioning (5 items). Separate questionnaires for ages 2 to 4 (toddler), 5-7, 8-12, and 13-18 years are used for parent proxy-reporting, which assesses parents' perceptions of their child's HRQOL. The instructions ask how much of a problem each item has been during the past 1 month; each item is answered on a 5-point scale: 0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem. Scores from the 4 subscales, the total score, and the psychosocial composite score were generated using standard algorithms. Each item's score in the questionnaire was converted to a 0 to 100 scale (with higher scores indicating better HRQOL). Baseline, Week 13 and Week 25 (or end of study visit if earlier than Week 25)
Secondary Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores The PedsQL child self-reported questionnaire was used in children > 5 years old. The 23-item PedsQL 4.0 includes physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), and school functioning (5 items). Separate questionnaires for ages 5-7, 8-12, and 13-18 years was used for child self-reporting. The instructions asked how much of a problem each item has been during the past 1 month; each item is answered on a 5-point scale for ages 8 to 18 (0 = never a problem; 1 = almost never a problem; 2 = sometimes a problem; 3 = often a problem; 4 = almost always a problem), or simplified to a 3-point scale for ages 5 to 7 (0 = not at all a problem; 2 = sometimes a problem; 4 = a lot of a problem). Scores from the 4 subscales, the total score, and the psychosocial composite score were generated using standard algorithms. Each item's score in the questionnaire was converted to a 0 to 100 scale (with higher scores indicating better HRQOL). Baseline, Week 13 and Week 25 (or end of study visit if earlier than Week 25)
Secondary Number of Participants With Treatment-emergent Adverse Events A serious adverse event (SAE) is defined as an adverse event that meets at least one of the following serious criteria: • is fatal, • is life threatening, • requires in-patient hospitalization or prolongation of existing hospitalization, • results in persistent or significant disability/incapacity, • is a congenital anomaly/birth defect, and/or • other significant medical hazard. The investigator assessed whether the adverse event was related to the investigational product (IP). Events of interest included hypertension, ischemic heart disease, cardiac failure, cerebrovascular disorders, convulsions, embolic and thrombotic events, embolic and thrombotic events: venous, embolic and thrombotic events: arterial, embolic and thrombotic events: vessel type unspecified and mixed arterial and venous, dialysis vascular access thrombosis, antibody-mediated pure red cell aplasia, hypersensitivity, lack of efficacy-effect, and malignancies. 25 weeks
Secondary Hemoglobin Serial Rate of Change (ROC) Over Time Calculated using the serial method as the change in hemoglobin from the previous non-missing hemoglobin level divided by number of days in between, and then multiplied by 7. 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.
Secondary Number of Participants With Hemoglobin > 12.0, > 13.0, and > 14.0 g/dL During the Study 25 weeks
Secondary Maximum Increase in Hemoglobin Over Any 2 Week Period The maximum increase between any 2 non-missing hemoglobin measurements over any 2-week period from Day 1. 25 weeks
Secondary 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.
Secondary 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.
Secondary Number of Participants Who Developed Anti-erythropoiesis Antibodies Participants who were negative for anti-erythropoiesis antibodies at Baseline (pre-dose) and who developed anti-erythropoiesis antibodies during the study. Serum samples were tested using Amgen's Surface Plasmon Resonance Immunoassay (SPRIA) method. 25 weeks
Secondary Darbepoetin Alfa Serum Concentrations for Participants Less Than 6 Years of Age Serum concentrations of darbepoetin alfa were measured by an enzyme-linked immunosorbent assay (ELISA). Weeks 1, 2, and 3 before the investigational product dose and 2 days after the first investigational product dose
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