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

NCT ID: NCT04925011

Last Updated: 2021-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-12-30

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.

Detailed Description

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

Conditions

Anemia Associated With Chronic Kidney Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Roxadustat

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

Group Type: OTHER

Roxadustat

Intervention Type: DRUG

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

Interventions

Roxadustat

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mao Jianhua

OTHER

Sponsor Role: lead

Responsible Party

Mao Jianhua

Chief Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

jianhua Map, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital, Zhejiang University School of Medicine

Locations

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

jianhua Mao, MD

Role: CONTACT

maojh88@zju.edu.cn

086-571-86670015

fei Liu

Role: CONTACT

alexdevin@163.com

Facility Contacts

Mao Jianhua

Role: primary

maojh88@zju.edu.cn

13616819071

Other Identifiers

Roxadustat for pediatric CKD

Identifier Type: -

Identifier Source: org_study_id