Roxadustat and hepatic erythropoetin productio

Not Applicable

• Conditions: Renal anemia; renal anemia, chronic kidney disease, roxadustat, erythropoietin

• Registration Number: JPRN-jRCT1041210141
• Lead Sponsor: Hamano Takayuki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-03
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of erythropoietin derived from kidneys or liver 1-2 week and 12 weeks after swithing from ESA to <br>roxadustat

Secondary Outcome Measures

Name	Time	Method
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