UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059065 |
|---|---|
| Receipt number | R000066663 |
| Scientific Title | A study on the effect of selective uric acid reabsoiption inhibitor (SURI: dotinurad) on renal fuunction-related parameters in patients with hyperuricemia |
| Date of disclosure of the study information | 2025/09/12 |
| Last modified on | 2025/09/12 09:13:35 |
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Basic information
Public title
Study on renal protective effect of serum urate lowering therapy
Acronym
Study on renal protective effect of serum urate lowering therapy
Scientific Title
A study on the effect of selective uric acid reabsoiption inhibitor (SURI: dotinurad) on renal fuunction-related parameters in patients with hyperuricemia
Scientific Title:Acronym
A study on the effect of selective uric acid reabsoiption inhibitor (SURI: dotinurad) on renal fuunction-related parameters in patients with hyperuricemia
Region
| Japan |
Condition
Condition
hyperuricemia
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To follow and compare the rate of decline in eGFR at the start of treatment and every 24 weeks for 3 years in more tightly controlled serum uric acid levels
Basic objectives2
Others
Basic objectives -Others
Effect of SURI on pathology associated with chronic kidney disease
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Rate of decline of eGFR at the start of treatment and every 24 weeks
Changes in serum uric acid level and Cre(eGFR)
Key secondary outcomes
Subjective symptoms and objective findings
Hematological tests: white blood cells, red blood cells, hemoglobin, hematocrit, platelets
Blood biochemistry tests: BUN, creatinine, UA, AST, ALT, LDH, albumin, electrolytes (Na, K, Cl), indoxyl sulfate, ALP, iPTH, Ca, Mg, IP, T-Cho, TG, HDL-C, LDL-C, CRP, FGF23, erythropoietin concentration, HCO3
Urine tests: urine qualitative (protein, sugar, urobilinogen, occult blood, ketones, pH, specific gravity), urine sediment, urinary Cr, urinary UA, be-ta2MG, NAG, NGAL
Abdominal CT scan:
Ultrasound tests: carotid artery IMT, cardiac echo, renal echo (RI, SWE)
Physiological tests: FMD, SPP, CAVI
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
For patients with serum uric acid levels>6.0mg/dl,dotinurad 0.5mg/day will be added,or the dotinurad dosage will be adjusted so that serum uric acid levels are 2-6mg/dl and serum uric acid fluctuations are within 0.5mg/dl with follow-up every 4(+/-2) weeks, and continued for up to 2 months. The choice of additional administration group or switch group will be made at the discretion of the attending physician based on the type of uric acid lowering drug,the patient's wishes,personality,compliance,etc.For uric acid levels <2.0mg/dl,dotinurad will be reduced or discontinued.
(i)New dotinurad administration group:For patients with hyperuricemia (>6.0mg/dl),dotinurad 0.5mg/day will be started after obtaining consent. Increase dotinurad to keep serum uric acid levels within 2-6mg at follow-up every 4(+/-2) weeks
Interventions/Control_2
(ii) Dotinurad addition group taking other uric acid-lowering drugs: Start dotinurad 0.5 mg/day as above after obtaining consent
*Switching of uric acid excretion-promoting drugs is recommended to prevent renal urinary tract stones.
Interventions/Control_3
(iii).Switch dotinurad group while taking other uric acid lowering drugs:After obtaining consent, the dotinurad dose is a maximum of 4mg/day,calculated as follows.Adjust serum uric acid levels to keep within 2-6mg/dl at follow-up every 4(+/-2) weeks
*Switching uric acid excretion promoting drugs is recommended to prevent kidney stones
Allopurinol 50mg 100mg;Dotinurad 0.5mg 1mg Febuxostat 10mg 20mg 40mg;Dotinurad 0.5mg 1mg 2mg Topiroxostat 20mg 40mg 60mg:Dotinurad 0.5mg 1mg 2mg Benzbromarone 50mg=Converted in Dotinurad 2mg, Probenecid 1000mg=Converted in dotinurad 2mg, Bucolom 600mg=Converted in dotinurad 2mg.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with hyperuricaemia (>6.0 mg/dl)
2) Patients without renal urinary tract stones on computed tomography (CT)
3) Patients aged 20 years or older (regardless of gender) at the time of consent
4) Patients who have been fully informed about their participation in this study and have given their free written consent to participate in the study after having been fully informed of the study
5) Patients who are attending an outpatient clinic at the time of consent
Key exclusion criteria
1) Patients with hypouricemia (<2.0 mg/dl)
2) Patients with a history of urinary tract stones or the presence of renal UTI stones evident on imaging
3) Patients who have taken Dotinurado. within 26 weeks prior to obtaining consent
4) Women who are pregnant or may become pregnant
5) Women who are breastfeeding
6) Patients who received other study drugs or investigational drugs within 3 months before starting study drug administration
7) Patients with a history of hypersensitivity to any component of the study drug
8) Other patients deemed unsuitable as study subjects by the principal investigator
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | kyoko |
| Middle name | |
| Last name | maesato |
Organization
shonan kamakura general hospital
Division name
Kidney disease and transplant center
Zip code
247-8533
Address
1370-1, Okamoto, Kamakura City, Kanagawa, 247-8533 JAPAN
TEL
0467-46-1717
kyoko.maesato@tokushukai.jp
Public contact
Name of contact person
| 1st name | kyoko |
| Middle name | |
| Last name | maesato |
Organization
shonan kamakura general hospital
Division name
kidney disease and transplant center
Zip code
247-8533
Address
1370-1, Okamoto, Kamakura City, Kanagawa 247-8533 JAPAN
TEL
0467-46-1717
Homepage URL
https://www.skgh.jp/
kyoko.maesato@tokushukai.jp
Sponsor or person
Institute
Tokushukai Medical Corporation Shonan Kamakura General Hospital (Clinical Research Center)
Institute
Department
Personal name
Funding Source
Organization
shonan kamakura general 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
Mirai Iryo Research Center Inc.
Address
1-3-1, Kudan-minami, Chiyoda-ku, Tokyo 102-0074, Japan
Tel
03-3263-4801
mirai-ec1@mirai-iryo.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
神奈川県
Institutions
Institutions
湘南鎌倉総合病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2029 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 12 | Day |
Last modified on
| 2025 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066663
