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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042873
Receipt No. R000048935
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.
Date of disclosure of the study information 2021/01/05
Last modified on 2021/01/04

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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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