Roxadustat and hepatic erythropoetin production

JRCT ID: jRCT1041210141

Registered date:03/02/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Renal anemia
• Date of first enrollment: 23/03/2022
• Target sample size: 40
• Study type: Observational

Outcome(s)

Primary Outcome

Proportion of erythropoietin derived from kidneys or liver 1-2 week and 12 weeks after swithing from ESA to
roxadustat

• Secondary Outcome: Proportion of patients achieving target hemoglobin of 10-12g/dL 12 weeks after initiation of roxadustat, hemogloin, erythroferron, and hepcidin levels 12 weeks after initiation of roxadustat

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 95age old
• Gender: Both

Include criteria

Hemodialysis patients
age>=20 and <95
dialysis vintage > 15 years
receiving treatment with erythropoiesis stimulating agents (ESA)
requiring change from ESA to HIF-PH inhibitors for clinical reasons
those who consent to participation to the research
Patients with non-dialysis dependent chronic kidney disease
age>=20 and <95
receiving treatment with ESA
requiring change from ESA to HIF-PH inhibitors for clinical reasons
those who consent to participation to the research

Exclude criteria

Those with malignancy
Those with deep venous thrombosis
Hematologic malignancy including myelodysplastic syndrome
Iron deficiency (transferrin saturation <20% or ferritin <100ng/mL)
Active bleeding
Liver dysfunction (Child Pugh class B or C)
Diabetic proliferative retinopathy
Those who were deemed to be ineligible by treating physicians

Related Information

• Primary Sponsor: Hamano Takayuki
• Secondary Sponsor: Murashima Miho
• Source(s) of Monetary Support: Astellas Pharm Inc.