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

NCT00436748 | Terminated Phase 3 Results

• 1 other identifier: 20050256
• Study Type: interventional
• Target: 116
• Locations: 10 countries
• Sites: 67

Brief Summary

The primary objectives of this study are the following:

1. 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. 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.

Conditions

Anemia; Chronic Kidney Disease; Kidney Disease

Keywords

Chronic Kidney Disease; Dialysis; Anemia; Nephrology; Pediatric; Hemodialysis; Peritoneal Dialysis; Chronic Renal Insufficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• 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)

Study Arms (2)

Darbepoetin Alfa QW

EXPERIMENTAL

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

Darbepoetin Alfa Q2W

EXPERIMENTAL

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; Drug: Placebo

Interventions

Darbepoetin Alfa DRUG

Administered by subcutaneous or intravenous injection

Also known as: Aranesp®

Darbepoetin Alfa Q2W; Darbepoetin Alfa QW

Placebo DRUG

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

Darbepoetin Alfa Q2W

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (67)

Research Site

Birmingham, Alabama, 35233, United States

Location

Research Site

Los Angeles, California, 90027, United States

Location

Research Site

Los Angeles, California, 90095, United States

Location

Research Site

San Diego, California, 92123, United States

Location

Research Site

San Francisco, California, 94143, United States

Location

Research Site

Stanford, California, 94305-5208, United States

Location

Research Site

Washington D.C., District of Columbia, 20010, United States

Location

Research Site

Gainesville, Florida, 32610, United States

Location

Research Site

Miami, Florida, 33136, United States

Location

Research Site

Orlando, Florida, 32806, United States

Location

Research Site

Boise, Idaho, 83712, United States

Location

Research Site

Chicago, Illinois, 60612, United States

Location

Research Site

Iowa City, Iowa, 52242, United States

Location

Research Site

Louisville, Kentucky, 40202, United States

Location

Research Site

New Orleans, Louisiana, 70118, United States

Location

Research Site

Baltimore, Maryland, 21287, United States

Location

Research Site

Boston, Massachusetts, 02115, United States

Location

Research Site

Kansas City, Missouri, 64108, United States

Location

Research Site

Livingston, New Jersey, 07039, United States

Location

Research Site

New Brunswick, New Jersey, 08901, United States

Location

Research Site

Albuquerque, New Mexico, 87131, United States

Location

Research Site

Buffalo, New York, 14222, United States

Location

Research Site

New Hyde Park, New York, 11040, United States

Location

Research Site

New York, New York, 10029, United States

Location

Research Site

The Bronx, New York, 10467, United States

Location

Research Site

Valhalla, New York, 10595, United States

Location

Research Site

Charlotte, North Carolina, 28203, United States

Location

Research Site

Akron, Ohio, 44308, United States

Location

Research Site

Cincinnati, Ohio, 45229, United States

Location

Research Site

Cleveland, Ohio, 44106, United States

Location

Research Site

Cleveland, Ohio, 44195, United States

Location

Research Site

Columbus, Ohio, 43205, United States

Location

Research Site

Portland, Oregon, 97227, United States

Location

Research Site

Portland, Oregon, 97239, United States

Location

Research Site

Philadelphia, Pennsylvania, 19104, United States

Location

Research Site

Dallas, Texas, 75390, United States

Location

Research Site

Houston, Texas, 77030, United States

Location

Research Site

San Antonio, Texas, 78229, United States

Location

Research Site

Charlottesville, Virginia, 22908, United States

Location

Research Site

Norfolk, Virginia, 23507, United States

Location

Research Site

Richmond, Virginia, 23219, United States

Location

Research Site

Seattle, Washington, 98105, United States

Location

Research Site

Edegem, 2650, Belgium

Location

Research Site

Ghent, 9000, Belgium

Location

Research Site

Leuven, 3000, Belgium

Location

Research Site

Jūrmala, 2015, Latvia

Location

Research Site

Vilnius, 08406, Lithuania

Location

Research Site

Mexico City, Mexico City, 06720, Mexico

Location

Research Site

Aguascalientes, 20230, Mexico

Location

Research Site

Chihuahua City, 31000, Mexico

Location

Research Site

Puebla City, 72190, Mexico

Location

Research Site

Gdansk, 80-952, Poland

Location

Research Site

Lodz, 93-338, Poland

Location

Research Site

Szczecin, 70-410, Poland

Location

Research Site

San Juan, 00935, Puerto Rico

Location

Research Site

Krasnodar, 350033, Russia

Location

Research Site

Moscow, 107014, Russia

Location

Research Site

Moscow, 117997, Russia

Location

Research Site

Orenburg, 460004, Russia

Location

Research Site

Saint Petersburg, 198205, Russia

Location

Research Site

Samara, 443095, Russia

Location

Research Site

Banská Bystrica, 974 09, Slovakia

Location

Research Site

Bratislava, 833 40, Slovakia

Location

Research Site

Košice, 040 11, Slovakia

Location

Research Site

Birmingham, B4 6NH, United Kingdom

Location

Research Site

Leeds, LS1 3EX, United Kingdom

Location

Research Site

London, SE1 7EH, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 28815341 BACKGROUND

• Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.

  PMID: 36791280 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic; Kidney Diseases

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2007
• First Posted: February 19, 2007
• Study Start: September 16, 2008
• Primary Completion: March 3, 2014
• Study Completion: March 3, 2014
• Last Updated: November 29, 2022
• Results First Posted: March 31, 2015

Record last verified: 2022-11

Locations

RU (6); PL (3); PR (1); SL (3); US (42); LI (1); BE (3); LA (1); GB (3); ME (4)