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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039729
Receipt No. R000045255
Scientific Title Different Response to Roxadustat Treatment for Anemia Between Patients Undergoing Hemodialysis and Peritoneal Dialysis.
Date of disclosure of the study information 2020/03/06
Last modified on 2020/03/06

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Basic information
Public title Different Response to Roxadustat Treatment for Anemia Between Patients Undergoing Hemodialysis and Peritoneal Dialysis.
Acronym Different Response to Roxadustat between HD and PD
Scientific Title Different Response to Roxadustat Treatment for Anemia Between Patients Undergoing Hemodialysis and Peritoneal Dialysis.
Scientific Title:Acronym Different Response to Roxadustat between HD and PD
Region
Japan

Condition
Condition End Stage Renal Disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify whether the erythropoietic response to Roxadustat is different between HD patients and PD patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The prespecified primary outcome was the average dose of roxadustat during weeks 23 through 27.
Key secondary outcomes The secondary outcome was the prevalence of subject whose Hb levels increased 1.0 g/dL or 2.0 g/dL in first 4 weeks.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria This study enrolled patients who were receiving maintenance HD or PD and were prescribed ESA.
Key exclusion criteria Malignancy
Blood disease that medical doctor considers not appropriate
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Hironori
Middle name
Last name Kobayashi
Organization Japanese Red Cross Asahikawa Hospital
Division name Nephrology
Zip code 070-8530
Address 1-1, 1jo 1 chome Akebono, Asahikawa, Hokkaido
TEL 0166228111
Email hkoba1974@gmail.com

Public contact
Name of contact person
1st name Keitaro
Middle name
Last name Nishizawa
Organization Japanese Red Cross Asahikawa Hospital
Division name Nephrology
Zip code 070-8530
Address 1-1, 1jo 1 chome Akebono, Asahikawa, Hokkaido
TEL 0166228111
Homepage URL
Email nishizawa.1114@gmail.com

Sponsor
Institute Japanese Red Cross Asahikawa Hospital
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Japanese Red Cross Asahikawa Hospital Ethics Committee
Address 1-1, 1jo 1 chome Akebono, Asahikawa, Hokkaido
Tel 0166228111
Email soumu@asahikawa-rch.gr.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 日本赤十字社旭川赤十字病院

Other administrative information
Date of disclosure of the study information
2020 Year 03 Month 06 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 02 Month 06 Day
Date of IRB
2020 Year 02 Month 27 Day
Anticipated trial start date
2020 Year 03 Month 09 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study
After informed consent will be provided, roxadustat will be prescribed instead of darbepoetin according to the attached document of roxadustat in Japan. Hb level will be checked at least every two weeks. Roxadustat will be titrated according to Hb target range of 10-12 g/dL according to the guidelines. The use of oral or intravenous iron therapy including ferric citrate hydrate is allowed.

Management information
Registered date
2020 Year 03 Month 06 Day
Last modified on
2020 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045255

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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