UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057381 |
|---|---|
| Receipt number | R000065553 |
| Scientific Title | Efficacy and Safety of Dotinurad in Patients with Advanced Chronic Kidney Disease |
| Date of disclosure of the study information | 2025/03/25 |
| Last modified on | 2025/03/24 17:22:20 |
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Basic information
Public title
Efficacy and Safety of Dotinurad in Patients with Advanced Chronic Kidney Disease
Acronym
Efficacy and Safety of Dotinurad in Patients with Advanced Chronic Kidney Disease
Scientific Title
Efficacy and Safety of Dotinurad in Patients with Advanced Chronic Kidney Disease
Scientific Title:Acronym
Efficacy and Safety of Dotinurad in Patients with Advanced Chronic Kidney Disease
Region
| Japan |
Condition
Condition
Chronic kidney disease patients with hyperuricemia
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the uric acid-lowering effect, safety, and impact on renal function of dothinurad in hyperuricemic patients with CKD G3b to G5
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum uric acid level after 6 months of treatment with Dotinurad
Key secondary outcomes
eGFR at 6 months before and after dothinurad 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 Ibaraki Prefectural Central Hospital and Ibaraki Regional Cancer Center as outpatients between April 2022 and September 2024 and were prescribed dotinurad for hyperuricemia were included. Patients were selected if their estimated glomerular filtration rate (eGFR) was less than 45 mL/min/1.73 m2 at the time of administration, and serum creatinine and serum uric acid levels could be evaluated 6 months before and after administration.
Key exclusion criteria
Patients who had a new intervention of other drugs after the start of dothinurad were excluded.
Target sample size
14
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
| 2025 | Year | 03 | Month | 25 | 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
14
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
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | 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 Ibaraki Prefectural Central Hospital and Ibaraki Regional Cancer Center as outpatients between April 2022 and September 2024 and were prescribed dotinurad for hyperuricemia were included. Patients whose estimated glomerular filtration rate (eGFR) was less than 45 mL/min/1.73 m2 at the time of administration, and whose serum creatinine and serum uric acid levels could be evaluated 6 months before and after administration were included. Patients were evaluated retrospectively.
Management information
Registered date
| 2025 | Year | 03 | Month | 24 | Day |
Last modified on
| 2025 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065553
