臨床研究等提出・公開システム

Date of registration	Feb. 03, 2022
Last modified on	Feb. 27, 2024
Trial ID	jRCT1041210141

Scientific Title	The effect of roxadustat on erythropoietin production from liver among patients on long-term maintenance hemodialysis or patients with non-dialysis dependent chronic kidney disease
Public Title	Roxadustat and hepatic erythropoetin production

Contact for Scientific Queries	Name	Hamano Takayuki
	Affiliation	Nagoya City University Hospital
	Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
	Telephone	+81-528587429
	E-mail	hamatea@med.nagoya-cu.ac.jp
Contact for Public Queries	Name	Murashima Miho
	Affiliation	Nagoya City University Hospital
	Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
	Telephone	+81-528587429
	E-mail	mmurashi@med.nagoya-cu.ac.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Feb. 03, 2022
Actual date of first enrollment		Mar. 23, 2022
Target sample size		40
Study Type		Observational
Key inclusion & exclusion criteria	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
	Age Minimum	20age old over
	Age Maximum	95age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Renal anemia
Health Condition(s) Keyword		renal anemia, chronic kidney disease, roxadustat, erythropoietin
Primary Outcome(s)		Proportion of erythropoietin derived from kidneys or liver 1-2 week and 12 weeks after swithing from ESA to roxadustat
Secondary Outcome(s)		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

Primary Sponsor	Nagoya City University

Source of Monetary Support / Secondary Sponsor	Astellas Pharm Inc.
Secondary Sponsor	Not applicable

Name of Certified Review Board	Nagoya City University Institutional Review Board
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
Telephone	+81-52-853-8348
E-Mail	irb_jimu@med.nagoya-cu.ac.jp
Approval Status	Approval
Date of approval	Nov. 19, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Feb. 27, 2024	(this page)	Changes
3	April. 12, 2022	Detail	Changes
2	Feb. 10, 2022	Detail	Changes
1	Feb. 03, 2022	Detail

List of change history