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

Sponsor

Mao Jianhua (Other)

Overall Status

Recruiting

CT.gov ID

NCT04925011

Collaborator

(none)

Enrollment

Location

Arm

15.9

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anemia Associated With Chronic Kidney Disease	Drug: Roxadustat	Phase 3

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Other: Roxadustat

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

Drug: Roxadustat

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

Outcome Measures

Primary Outcome Measures

Proportion of patients with mean Hb ≥ 11.0 g/dL [weeks 16-24]
After the use of roxadustat, the proportion of patients with mean Hb ≥ 11.0 g/dL

Secondary Outcome Measures

Mean change in Hb [weeks 16-24]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang	China

Sponsors and Collaborators

Mao Jianhua

Investigators

Principal Investigator: jianhua Map, MD, Children's Hospital, Zhejiang University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mao Jianhua, Chief Physician, The Children's Hospital of Zhejiang University School of Medicine

ClinicalTrials.gov Identifier:

NCT04925011

Other Study ID Numbers:

Roxadustat for pediatric CKD

First Posted:

Jun 14, 2021

Last Update Posted:

Aug 9, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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.:

Additional relevant MeSH terms:

Kidney Diseases

Renal Insufficiency, Chronic

Anemia

Study Results

No Results Posted as of Aug 9, 2021