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

NCT00436748 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2022-11-29

Study results available
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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.

Conditions

Interventions

DRUG

Darbepoetin Alfa

Administered by subcutaneous or intravenous injection

DRUG

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-16
Primary Completion
2014-03-03
Completion
2014-03-03

Countries

  • United States
  • Belgium
  • Latvia
  • Lithuania
  • Mexico
  • Poland
  • Puerto Rico
  • Russia
  • Slovakia
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00436748 on ClinicalTrials.gov