UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039729 |
|---|---|
| Receipt number | 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 18:54:50 |
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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
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
nishizawa.1114@gmail.com
Sponsor or person
Institute
Japanese Red Cross Asahikawa Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045255
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
