UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060295 |
|---|---|
| Receipt number | R000068976 |
| Scientific Title | Switching from febuxostat to dotinurad in patients with chronic kidney disease and hyperuricemia: a single-center, non-randomized study |
| Date of disclosure of the study information | 2026/01/08 |
| Last modified on | 2026/01/08 12:21:42 |
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Basic information
Public title
Evaluation of the efficacy of switching from a xanthine oxidase inhibitor (febuxostat) to a selective urate reabsorption inhibitor (dotinurad) in patients with hyperuricemia and chronic kidney disease (CKD).
Acronym
Evaluation of the efficacy of switching from febuxostat to dotinurad in patients with hyperuricemia and CKD.
Scientific Title
Switching from febuxostat to dotinurad in patients with chronic kidney disease and hyperuricemia: a single-center, non-randomized study
Scientific Title:Acronym
Switching from febuxostat to dotinurad in patients with chronic kidney disease and hyperuricemia
Region
| Japan |
Condition
Condition
Hyperuricemia with chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Xanthine oxidase inhibitors are widely used for patients with hyperuricemia and chronic kidney disease (CKD); however, their renoprotective effects remain controversial. Meanwhile, there is currently a paucity of reports regarding the effects of uricosuric agents on renal function in this patient population. The purpose of this study is to investigate the impact on renal function of switching from a xanthine oxidase inhibitor to a uricosuric agent in patients with hyperuricemia and CKD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patients were switched from the xanthine oxidase inhibitor febuxostat to the selective urate reabsorption inhibitor dotinurad. We compared renal function parameters (serum creatinine, cystatin C, and eGFR), serum uric acid levels, urinary protein, and the fractional excretion of uric acid (FEUA) between baseline (pre-switch) and three months after the switch.
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients were switched from the xanthine oxidase inhibitor febuxostat to the selective urate reabsorption inhibitor dotinurad, with the dosage adjusted according to the following conversion protocol:
Febuxostat 10 mg/day to dotinurad 0.5 mg/day
Febuxostat 20 mg/day to dotinurad 1 mg/day
Febuxostat 40 mg/day to dotinurad 2 mg/day
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients aged 20 years or older with hyperuricemia and stage G2-G4 chronic kidney disease (CKD) who are not undergoing dialysis.
(2) Patients currently receiving the xanthine oxidase inhibitor febuxostat.
Key exclusion criteria
(1) Presence of active gouty arthritis.
(2) Any other conditions that the attending physician considers unsuitable for study participation
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Taisuke |
| Middle name | |
| Last name | Irifuku |
Organization
NHO Higashihiroshima Medical Center
Division name
Department of Nephrology
Zip code
739-0041
Address
513 Jike, Saijo-cho, Higashihiroshima city, Hiroshima, Japan
TEL
082-423-2176
t.irifuku@gmail.com
Public contact
Name of contact person
| 1st name | Taisuke |
| Middle name | |
| Last name | Irifuku |
Organization
NHO Higashihiroshima Medical Center
Division name
Department of Nephrology
Zip code
739-0041
Address
513 Jike, Saijo-cho, Higashihiroshima city, Hiroshima, Japan
TEL
082-423-2176
Homepage URL
t.irifuku@gmail.com
Sponsor or person
Institute
NHO Higashihiroshima Medical Center
Institute
Department
Personal name
Funding Source
Organization
not applicable
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
National Hospital Organization Higashihiroshima Medical Center Ethics Committee
Address
513 Jike, Saijo-cho, Higashihiroshima city, Hiroshima, Japan
Tel
082-423-2176
shinhara.maki.un@mail.hosp.go.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
60
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
| 2025 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 11 | 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
| 2026 | Year | 01 | Month | 08 | Day |
Last modified on
| 2026 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068976
