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

  • STATUS
    Recruiting
  • days left to enroll
    26
  • participants needed
    30
  • sponsor
    Mao Jianhua
Updated on 17 August 2021

Summary

This open-labeled, one-center study is designed to evaluate the efficacy and safety of roxadustat in ESA-nave and ESA-treated pediatric patients with CKD Stages 3, 4, and 5 who are receiving dialysis or not. The study will enroll patients between the ages of 2 to <18 years. Approximately 30 patients will be enrolled.

Description

This study is to evaluate the use of roxadustat for renal anemia in pediatric patients with CKD

Details
Condition Anemia Associated With Chronic Kidney Disease
Treatment Roxadustat
Clinical Study IdentifierNCT04925011
SponsorMao Jianhua
Last Modified on17 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Estimated glomerular filtration rate (Bedside Schwartz formula) of < 60 ml/min/1.73 m2 (stage 3, 4 and 5 CKD) for dialysis or non-dialysis patients
For ESA-nave patients, mean of two most recent central laboratory Hb values during the screening period obtained at least 2 days apart must be < 11.0 g/dL. For patients currently receiving stable ESA dosing who will discontinue ESA and convert to roxadustat during study, mean of two most recent central laboratory Hb values during the screening period obtained at least 2 days apart must be 9.0 g/dL and 12.5 g/dL
Ferritin >50 ng/mL and transferrin saturation >10%

Exclusion Criteria

Uncontrolled hypertension as judged by the principal investigator prior to screening
Known hematologic disease related anemia (including PRCA)
Known malignancy within the past 5 years before screening
History of severe anaphylaxis or known allergic to ingredient of roxadusta
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 3x upper limit of normal (ULN) and total bilirubin (Tbili) 2x ULN(obtained from screening visit)
Serum folate and vitamin B12 > LLN and cannot be corrected (obtained from screening visit)
Any RBC transfusion during the past 4 weeks before screening
Weight<10kg
Any prior exposure to roxadustat or any other HIF-PH inhibitor
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