UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046180
Receipt No. 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 2021/11/25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email hkondo@oita-u.ac.jp

Sponsor
Institute Oita University
Institute
Department

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
Email 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 Preinitiation
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
2023 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
2021 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052709

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.