A Study to Investigate the Effect of Roxadustat Versus Recombinant Human Erythropoietin (rHuEPO) on Oral Iron Absorption in Chinese Patients With Anemia of Chronic Kidney Disease (CKD)

PHASE4CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

February 22, 2021

Primary Completion Date

October 12, 2021

Study Completion Date

October 12, 2021

Conditions
Anemia of Chronic Kidney Disease
Interventions
DRUG

Roxadustat

The starting dose of roxadustat will be in accordance with the China package insert, and will depend on the body weight of the patient: 100 mg (45 to \< 60 kg) or 120 mg (≥ 60 kg) in patients on dialysis; 70 mg (40 to \< 60 kg) or 100 mg (≥ 60 kg) in non-dialysis patients.

DRUG

rHuEPO

The starting dose of rHuEPO will be in accordance to the dosage approved in rHuEPO China package insert (patients on weekly dose of 6000 IU \[dosing will BIW\], and patients on weekly dose of \>6000 IU \[dosing will TIW\]) and on patient's haemoglobin levels.

Trial Locations (8)

14010

Research Site, Baotou

100029

Research Site, Beijing

100044

Research Site, Beijing

100730

Research Site, Beijing

110001

Research Site, Shenyang

250012

Research Site, Jinan

430022

Research Site, Wuhan

510180

Research Site, Guangzhou

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Parexel

INDUSTRY

lead

AstraZeneca

INDUSTRY