UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046180 |
|---|---|
| Receipt number | R000052709 |
| Scientific Title | The Effect of switch from Febuxostat to Dotinurad on the serum levels of indoxyl sulfate in patients with chronic kidney |
| Date of disclosure of the study information | 2021/11/26 |
| Last modified on | 2024/01/04 12:50:19 |
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Basic information
Public title
The Effect of switch from Febuxostat to Dotinurad on the serum levels of indoxyl sulfate in patients with chronic kidney
Acronym
The Effect of switch from Febuxostat to Dotinurad on the serum levels of indoxyl sulfate in patients with chronic kidney
Scientific Title
The Effect of switch from Febuxostat to Dotinurad on the serum levels of indoxyl sulfate in patients with chronic kidney
Scientific Title:Acronym
The Effect of switch from Febuxostat to Dotinurad on the serum levels of indoxyl sulfate in patients with chronic kidney
Region
| Japan |
Condition
Condition
Hyperuricemia
Chronic kidney disease
Classification by specialty
| Medicine in general | Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to test the hyothesis whether the switch from Febuxostat to Dotinurad in patients with chronic kidney disease reduces the serum levels of indoxyl sulfate.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum indoxyl sulfate level
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
The switch from Febuxostat (20 mg/day) to Dotinurad (1 mg/day) in all the enrolled CKD patients.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) 19<Age<80
2) CKD(StageG3, eGFR30-60ml/min/1.73m2)
3) a patient with hyperuricemia taking oral febuxostat
4) male and female
5) outpatient clinic
Key exclusion criteria
1) severe heart failure (NYHA>2)
2) a patient taking oral statin
3) Liver dysfunction (Child Pugh - Grade B or C)
4) Allergy
5) a patient with chronic inflammatory disease taking NSAIDs, steroid and immunosuppressants.
6) a patient who is considered ineligible for enrolling the study by a principal investigator or sub-investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Naohiko |
| Middle name | |
| Last name | Takahashi |
Organization
Oita University
Division name
Faculty of Medicine
Zip code
879-5593
Address
1-1 idaigaoka Hasama-machi, Yufu, Oita
TEL
0975866166
takanao@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Hidekazu |
| Middle name | |
| Last name | Kondo |
Organization
Oita University
Division name
Faculty of Medicine
Zip code
879-5593
Address
1-1 idaigaoka Hasama-machi
TEL
0975866166
Homepage URL
hkondo@oita-u.ac.jp
Sponsor or person
Institute
Oita University
Institute
Department
Personal name
Funding Source
Organization
Oita University
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
Oita University
Address
1-1 idaigaoka Hasama-machi, Yufu, Oita
Tel
0975866166
hkondo@oita-u.ac.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 | 11 | Month | 26 | 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
| 2021 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2024 | 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
| 2021 | Year | 11 | Month | 25 | Day |
Last modified on
| 2024 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052709
| 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 |
