UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039234 |
|---|---|
| Receipt number | R000044650 |
| Scientific Title | Study of effectiveness and safety of roxadustat for renal anemia in dialysis patients |
| Date of disclosure of the study information | 2020/02/01 |
| Last modified on | 2021/07/23 11:22:27 |
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Basic information
Public title
Study of effectiveness and safety of roxadustat for renal anemia in dialysis patients
Acronym
roxadustat study
Scientific Title
Study of effectiveness and safety of roxadustat for renal anemia in dialysis patients
Scientific Title:Acronym
roxadustat study
Region
| Japan |
Condition
Condition
Renal anemia in dialysis patients
Classification by specialty
| Nephrology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness and safety of roxadustat for renal anemia in dialysis patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hb(evaluated before administration and 4, 12, and 24 weeks after administration)
Key secondary outcomes
Blood test(MCV,MCH,MCHC,reticulocyte count,erythropoietin,serum iron,ferritin,TIBC and TSAT),blood pressure,activity(frail checklist prepared by the Ministry of Health, Labor and Welfare)and digestive symptoms(Gastrointestinal Symptom Rating Scale).
All evaluated before administration and 4, 12, and 24 weeks after administration.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Any of our maintenance hemodialysis patients with no improvement in anemia after existing treatment for various causes and serum ferritin >= 300 ng/ml, epoetin kappa dose >= 9000 international units/week, darbepoetin alpha dose >= 40 micrograms/week, or epoetin beta pegol dose >=150 micrograms/four weeks.
Key exclusion criteria
Patient with thromboembolism within 6 months after treatment, malignant tumor during treatment, eye disease during treatment, and moderate or higher liver dysfunction.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Junki |
| Middle name | |
| Last name | Aikawa |
Organization
Nagakubo Hospital
Division name
Dr
Zip code
186-0011
Address
6907-1 Yaho Kunitachi Tokyo, 186-0011, Japan
TEL
042-571-2211
shiki12070712@gmail.com
Public contact
Name of contact person
| 1st name | Junki |
| Middle name | |
| Last name | Aikawa |
Organization
Nagakubo Hospital
Division name
Dr
Zip code
186-0011
Address
6907-1 Yaho Kunitachi Tokyo, 186-0011, Japan
TEL
042-571-2211
Homepage URL
shiki12070712@gmail.com
Sponsor or person
Institute
Nagakubo Hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Nagakubo Hospital
Address
6907-1 Yaho Kunitachi Tokyo, 186-0011, Japan
Tel
042-571-2211
nagakubohospital1f@yahoo.co.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
| 2020 | Year | 02 | Month | 01 | 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
8
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 | 01 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing paticular
Management information
Registered date
| 2020 | Year | 01 | Month | 22 | Day |
Last modified on
| 2021 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044650
| 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 |
