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

Primary Purpose

Anemia Associated With Chronic Kidney Disease

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Roxadustat

About this trial

This is an interventional treatment trial for Anemia Associated With Chronic Kidney Disease

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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-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%

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.

Sites / Locations

Children's Hospital, Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Roxadustat

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mean change in Hb

Full Information

NCT ID

NCT04925011

First Posted

June 8, 2021

Last Updated

August 5, 2021

Sponsor

Mao Jianhua

1. Study Identification

Unique Protocol Identification Number

NCT04925011

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2021 (Anticipated)

Primary Completion Date

June 30, 2022 (Anticipated)

Study Completion Date

December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mao Jianhua

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia Associated With Chronic Kidney Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Roxadustat

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Roxadustat

Intervention Description

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

Primary Outcome Measure Information:

Title

Proportion of patients with mean Hb ≥ 11.0 g/dL

Description

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

Time Frame

weeks 16-24

Secondary Outcome Measure Information:

Title

Mean change in Hb

Time Frame

weeks 16-24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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-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% 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

jianhua Mao, MD

Phone

086-571-86670015

maojh88@zju.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

fei Liu

alexdevin@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

jianhua Map, MD

Organizational Affiliation

Children's Hospital, Zhejiang University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Hospital, Zhejiang University School of Medicine

City

Hangzhou

State/Province

Zhejiang

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mao Jianhua

Phone

13616819071

maojh88@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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