UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060280 |
|---|---|
| Receipt number | R000068956 |
| Scientific Title | Effect of dotinurad on proteinuria in patients with hyperuricemia. |
| Date of disclosure of the study information | 2026/01/08 |
| Last modified on | 2026/01/07 12:20:48 |
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Basic information
Public title
Effect of dotinurad on proteinuria in patients with hyperuricemia.
Acronym
Effect of dotinurad on proteinuria in patients with hyperuricemia.
Scientific Title
Effect of dotinurad on proteinuria in patients with hyperuricemia.
Scientific Title:Acronym
Effect of dotinurad on proteinuria in patients with hyperuricemia.
Region
| Japan |
Condition
Condition
Patients with hyperuricemia and proteinuria
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of dotinurad on reducing proteinuria in patients with hyperuricemia and proteinuria.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proteinuria (urine protein/creatinine ratio) over 12 months following dotinurad administration
Key secondary outcomes
Serum uric acid levels and eGFR over 12 months following dotinurad 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who visited the outpatient department of Ibaraki Prefectural Central Hospital/Ibaraki Regional Cancer Center between April 2021 and September 2024 and were prescribed dotinurad for hyperuricemia were included. Among these, patients for whom serum uric acid levels, serum creatinine levels, and UPCR could be evaluated at 1, 3, 6, and 12 months post-administration and whose UPCR was 0.15 g/gCr or higher were included.
Key exclusion criteria
Patients who had a new intervention of other drugs after the start of dothinurad were excluded.
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | Hirayasu |
| Middle name | |
| Last name | Kai |
Organization
Ibaraki prefectural central hospital,Ibaraki cancer center
Division name
Nephrology
Zip code
3091703
Address
6528 Koibuchi, Kasama City, Ibaraki Prefecture
TEL
0296771121
hirayasu.kai@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Teppei |
| Middle name | |
| Last name | Motomura |
Organization
Ibaraki prefectural central hospital,Ibraki cancer center
Division name
Nephrology
Zip code
3091703
Address
6528 Koibuchi, Kasama City, Ibaraki Prefecture
TEL
0296771121
Homepage URL
teppei621621@gmail.com
Sponsor or person
Institute
Ibaraki prefectural central hospital,Ibraki cancer center
Institute
Department
Personal name
Funding Source
Organization
Ibaraki prefectural central hospital,Ibraki cancer center
Ibaraki Clinical Education and Training Center, University of Tsukuba Hospital
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
Ibaraki prefectural central hospital,Ibraki cancer center
Address
6528 Koibuchi, Kasama City, Ibaraki Prefecture
Tel
0296771121
kenkyu@chiken-chubyo.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
| 2026 | Year | 01 | Month | 08 | 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
23
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
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients who visited the outpatient department of Ibaraki Prefectural Central Hospital/Ibaraki Regional Cancer Center between April 2021 and September 2024 and were prescribed dotinurad for hyperuricemia were included. Among these, 23 patients were identified who had evaluable serum uric acid levels, serum creatinine levels, and UPCR at 1 month, 3 months, 6 months, and 12 months post-initiation and whose UPCR was 0.15 or higher g/gCr. These patients were retrospectively evaluated.
Management information
Registered date
| 2026 | Year | 01 | Month | 07 | Day |
Last modified on
| 2026 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068956
