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

NCT04925011 | Unknown Phase 3

• 1 other identifier: Roxadustat for pediatric CKD
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This open-labeled, one-center study is designed to evaluate the efficacy and safety of roxadustat in ESA-naïve 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.

Conditions

Anemia Associated With Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with mean Hb ≥ 11.0 g/dL

  After the use of roxadustat, the proportion of patients with mean Hb ≥ 11.0 g/dL

  weeks 16-24

Secondary Outcomes (1)

• Mean change in Hb

  weeks 16-24

Study Arms (1)

Roxadustat

OTHER

Starting doses of 20, 50, 70 or 100 mg/30,70,90,or 120mg based on weight and dialysis or not.

Drug: Roxadustat

Interventions

Roxadustat DRUG

Starting doses of 20, 50, 70 or 100 mg/30,70,90,or 120mg based on weight and dialysis or not.

Roxadustat

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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-naïve 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mao Jianhua: lead

Study Sites (1)

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Interventions

roxadustat

Study Officials

• jianhua Map, MD

  Children's Hospital, Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jianhua Mao, MD

CONTACT

086-571-86670015; maojh88@zju.edu.cn

fei Liu

CONTACT

alexdevin@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 14, 2021
• Study Start: September 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: December 30, 2022
• Last Updated: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)