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

Condition(s) targeted: Anemia; Chronic Kidney Disease; Kidney Disease

Intervention: darbepoetin alfa QW (Drug); darbepoetin alfa Q2W (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

Overall contact:
Amgen Call Center, Phone: 866-572-6436

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

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome:

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

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

Secondary outcome:

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

To obtain pharmacokinetic (PK) data in subjects < 6 years of age

To assess the safety and tolerability of darbepoetin alfa administered QW and Q2W

To estimate Hb values over the duration of the study in the QW and Q2W arms

To estimate doses over the duration of the study in the QW and Q2W arms

Minimum age: 1 Year. Maximum age: 18 Years. Gender(s): Both.

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

Amgen Call Center, Phone: 866-572-6436

Research Site, Edegem 2650, Belgium; Completed

Research Site, Gent 9000, Belgium; Completed

Research Site, Leuven 3000, Belgium; Completed

Research Site, Jurmala 2015, Latvia; Completed

Research Site, Vilnius 08406, Lithuania; Recruiting

Research Site, Aguascalientes 20230, Mexico; Recruiting

Research Site, Puebla 72190, Mexico; Completed

Research Site, Gdansk 80-952, Poland; Recruiting

Research Site, Lodz 93-338, Poland; Recruiting

Research Site, Szczecin 70-410, Poland; Completed

Research Site, San Juan 00935, Puerto Rico; Completed

Research Site, Krasnodar 350033, Russian Federation; Recruiting

Research Site, Moscow 117997, Russian Federation; Completed

Research Site, Moscow 107014, Russian Federation; Recruiting

Research Site, Orenburg 460004, Russian Federation; Completed

Research Site, Saint Petersburg 198205, Russian Federation; Recruiting

Research Site, Samara 443095, Russian Federation; Completed

Research Site, Banska Bystrica 974 09, Slovakia; Recruiting

Research Site, Bratislava 833 40, Slovakia; Recruiting

Research Site, Kosice 040 11, Slovakia; Recruiting

Research Site, Birmingham B4 6NH, United Kingdom; Recruiting

Research Site, Leeds LS1 3EX, United Kingdom; Recruiting

Research Site, London SE1 7EH, United Kingdom; Recruiting

Research Site, Birmingham, Alabama 35233, United States; Recruiting

Research Site, Los Angeles, California 90095, United States; Recruiting

Research Site, Los Angeles, California 90027, United States; Recruiting

Research Site, San Diego, California 92123, United States; Recruiting

Research Site, San Francisco, California 94143, United States; Recruiting

Research Site, Stanford, California 94305-5208, United States; Recruiting

Research Site, Wahington, District of Columbia 20010, United States; Completed

Research Site, Mexico, Distrito Federal 06720, Mexico; Recruiting

Research Site, Gainesville, Florida 32610, United States; Completed

Research Site, Miami, Florida 33136, United States; Recruiting

Research Site, Orlando, Florida 32806, United States; Completed

Research Site, Orlando, Florida 32806, United States; Recruiting

Research Site, Boise, Idaho 83712, United States; Completed

Research Site, Chicago, Illinois 60612, United States; Recruiting

Research Site, Iowa City, Iowa 52242, United States; Recruiting

Research Site, Louisville, Kentucky 40202, United States; Recruiting

Research Site, New Orleans, Louisiana 70118, United States; Recruiting

Research Site, Baltimore, Maryland 21287, United States; Completed

Research Site, Boston, Massachusetts 02115, United States; Recruiting

Research Site, Kansas City, Missouri 64108, United States; Recruiting

Research Site, Livingston, New Jersey 07039, United States; Recruiting

Research Site, New Brunswick, New Jersey 08901, United States; Completed

Research Site, Albuquerque, New Mexico 87131, United States; Completed

Research Site, Bronx, New York 10467, United States; Completed

Research Site, Buffalo, New York 14222, United States; Completed

Research Site, New Hyde Park, New York 11040, United States; Completed

Research Site, New York, New York 10029, United States; Recruiting

Research Site, Valhalla, New York 10595, United States; Recruiting

Research Site, Charlotte, North Carolina 28203, United States; Completed

Research Site, Akron, Ohio 44308, United States; Completed

Research Site, Cincinnati, Ohio 45229, United States; Recruiting

Research Site, Cleveland, Ohio 44106, United States; Recruiting

Research Site, Cleveland, Ohio 44195, United States; Completed

Research Site, Columbus, Ohio 43205, United States; Recruiting

Research Site, Portland, Oregon 97239, United States; Recruiting

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Research Site, Philadelphia, Pennsylvania 19104, United States; Completed

Research Site, Dallas, Texas 75390, United States; Completed

Research Site, Houston, Texas 77030, United States; Recruiting

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Research Site, Charlottesville, Virginia 22908, United States; Recruiting

Research Site, Norfolk, Virginia 23507, United States; Recruiting

Research Site, Richmond, Virginia 23219, United States; Completed

Research Site, Seattle, Washington 98105, United States; Recruiting

AmgenTrials clinical trials website

Starting date: August 2008
Last updated: October 10, 2012