UMIN-CTR Clinical Trial

Basic information
Public title	Open-label crossover trial for the efficacy and safety of switching to HIF-PH inhibitor in anemic patients with maintenance hemodialysis treated by ESA.
Acronym	HIF-PH anemia study
Scientific Title	Open-label crossover trial for the efficacy and safety of switching to HIF-PH inhibitor in anemic patients with maintenance hemodialysis treated by ESA.
Scientific Title:Acronym	HIF-PH anemia study
Region	Japan

Condition
Condition	hemodialysis patient
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy and safety of switching to a HIF-PH inhibitor in patients using Darbepoetin.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Hb
Key secondary outcomes	Fe,ferritin,TSAT

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	After treatment with Roxadustat for 12 weeks, change to the therapy of Daprodustat for 12 weeks.
Interventions/Control_2	After treatment with Daprodustat for 12 weeks, change to the therapy of Roxadustat for 12 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Patients treated with Darbepoetin Alfa for more than 3 months before the trial. 2.Patients with stable hemoglobin level before the trial. 3.Maintenance hemodialysis and hemodiafiltration patients, three times a week.
Key exclusion criteria	1.Patients who have difficulty in taking oral medicine. 2.Patients on concomitant peritoneal dialysis. 3.Patients judged by the investigator to be unsuitable as subjects.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name misaki Middle name Last name moriishi
Organization	Nakajima tsuchiya clinic
Division name	dialysis treatment center
Zip code	730-0811
Address	6-1,Nakajima-cho,Naka-ku,Hiroshima-shi,Hiroshima
TEL	082-542-7271
Email	usagi@tsuchiya-hp.jp

Public contact
Name of contact person	1st name misaki Middle name Last name moriishi
Organization	Nakajima tsuchiya clinic
Division name	dialysis treatment center
Zip code	730-0811
Address	6-1,Nakajima-cho,Naka-ku,Hiroshima-shi,Hiroshima
TEL	082-542-7271
Homepage URL
Email	usagi@tsuchiya-hp.jp

Sponsor
Institute	Nakajima tsuchiya clinic
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tsuchiya general hospital ehic screening committee
Address	3-30,Nakajima-cho,Naka-ku,Hiroshima-shi,Hiroshima
Tel	082-542-9191
Email	jyamamoto@tsuchiya-hp.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 01 Month 05 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2020 Year 11 Month 09 Day
Date of IRB	2020 Year 11 Month 16 Day
Anticipated trial start date	2020 Year 11 Month 17 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 12 Month 29 Day
Last modified on	2021 Year 01 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048935

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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