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Investigating the Efficacy, Safety and PK of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKD

NCT04621331 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2022-07-05

No results posted yet for this study

Summary

This open-labeled, multicenter study is designed to evaluate the efficacy, safety and PK/PD of roxadustat in ESA-naïve and ESA-treated pediatric patients with CKD Stages 3, 4, and 5, as well as end-stage renal disease (ESRD) who are receiving either hemodialysis (HD) or peritoneal dialysis (PD). The study will enroll patients between the ages of 2 to \<18 years in two sequential cohorts, with the older cohort of ages 12 to \<18 years enrolled first. Approximately 30 patients will be enrolled in each age-based cohort.

Conditions

  • Anemia Associated With Chronic Kidney Disease

Interventions

DRUG

Roxadustat

HIF-PH inhibitor for treatment of anemia in CKD

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • FibroGen

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-23
Primary Completion
2022-05-23
Completion
2022-05-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT04621331 on ClinicalTrials.gov