UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042873
Receipt number 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 2023/01/03 17:04:02

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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 or person

Institute

Nakajima tsuchiya clinic

Institute

Department

Personal name



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

Completed

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

2023 Year 01 Month 03 Day



Link to view the page

Value
https://center6.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