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

This study has been terminated.
(Study Terminated; Commitment met per Regulatory Authorities.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00436748
First Posted: February 19, 2007
Last Update Posted: March 31, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amgen
  Purpose

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.

Condition Intervention Phase
Anemia Chronic Kidney Disease Kidney Disease Drug: Darbepoetin Alfa Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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:
  • Proportion of Participants Achieving Hemoglobin ≥ 10.0 g/dL [ Time Frame: 24 weeks ]
    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.


Secondary Outcome Measures:
  • Time to First Hemoglobin Value ≥ 10.0 g/dL [ Time Frame: 24 weeks ]
    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.

  • Hemoglobin Concentration Over Time [ Time Frame: 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 [ Time Frame: 24 weeks ]
    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.

  • Darbepoetin Alfa Weight-Adjusted Dose Over Time [ Time Frame: 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. ]
    Arithmetic means are provided; Withheld doses are counted as 0 μg.

  • Change From Baseline at Week 13 and Week 25 in Parent-reported Pediatric Quality of Life Inventory (PedsQL) Scores [ Time Frame: Baseline, Week 13 and Week 25 (or end of study visit if earlier than Week 25) ]
    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).

  • Change From Baseline at Week 13 and Week 25 in Child Self-reported Pediatric Quality of Life Inventory (PedsQL) Scores [ Time Frame: Baseline, Week 13 and Week 25 (or end of study visit if earlier than Week 25) ]
    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).

  • Number of Participants With Treatment-emergent Adverse Events [ Time Frame: 25 weeks ]
    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.

  • Hemoglobin Serial Rate of Change (ROC) Over Time [ Time Frame: 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. ]
    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.

  • Number of Participants With Hemoglobin > 12.0, > 13.0, and > 14.0 g/dL During the Study [ Time Frame: 25 weeks ]
  • Maximum Increase in Hemoglobin Over Any 2 Week Period [ Time Frame: 25 weeks ]
    The maximum increase between any 2 non-missing hemoglobin measurements over any 2-week period from Day 1.

  • Change From Baseline in Systolic Blood Pressure Over Time [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 25 weeks ]
    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.

  • Darbepoetin Alfa Serum Concentrations for Participants Less Than 6 Years of Age [ Time Frame: Weeks 1, 2, and 3 before the investigational product dose and 2 days after the first investigational product dose ]
    Serum concentrations of darbepoetin alfa were measured by an enzyme-linked immunosorbent assay (ELISA).


Enrollment: 116
Study Start Date: September 2008
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Darbepoetin Alfa QW
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.
Drug: Darbepoetin Alfa
Administered by subcutaneous or intravenous injection
Other Name: Aranesp®
Experimental: Darbepoetin Alfa Q2W
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.
Drug: Darbepoetin Alfa
Administered by subcutaneous or intravenous injection
Other Name: Aranesp®
Drug: Placebo
Matching placebo solution for subcutaneous or intravenous injection to maintain the blind in the Q2W arm.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00436748


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

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00436748     History of Changes
Other Study ID Numbers: 20050256
First Submitted: February 15, 2007
First Posted: February 19, 2007
Results First Submitted: March 4, 2015
Results First Posted: March 31, 2015
Last Update Posted: March 31, 2015
Last Verified: March 2015

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

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Darbepoetin alfa
Hematinics