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

Anemia Associated With Chronic Kidney Disease Clinical Trial

Official title:

An Open-label, One-center Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04925011
• Other study ID #: Roxadustat for pediatric CKD
• Status: Recruiting
• Phase: Phase 3
• Start date: September 1, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: August 2021
• Source: The Children's Hospital of Zhejiang University School of Medicine
• Contact: jianhua Mao, MD
• Phone: 086-571-86670015
• Email: maojh88[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

Inclusion Criteria:

1. 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.

2. 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

3. Ferritin >50 ng/mL and transferrin saturation >10%

Exclusion Criteria:

1. Uncontrolled hypertension as judged by the principal investigator prior to screening.

2. Known hematologic disease related anemia (including PRCA)

3. Known malignancy within the past 5 years before screening.

4. History of severe anaphylaxis or known allergic to ingredient of roxadusta.

5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3x upper limit of normal (ULN) and total bilirubin (Tbili) =2x ULN(obtained from screening visit).

6. Serum folate and vitamin B12 > LLN and cannot be corrected (obtained from screening visit).

7. Any RBC transfusion during the past 4 weeks before screening.

8. Weight<10kg

9. Any prior exposure to roxadustat or any other HIF-PH inhibitor.

Related Conditions & MeSH terms

• Anemia
• Anemia Associated With Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
China	Children's Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Mao Jianhua

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean change in Hb		weeks 16-24