UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061329 |
|---|---|
| Receipt number | R000070157 |
| Scientific Title | Subanalysis of RESTORE-nephropathy study (the research to explore the effects of a SGLT2 inhibitor, tofogliflozin, on renal protection estimated by first administration and readministration in patients with stage 2-3 diabetic nephropathy) |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2026/04/21 10:33:00 |
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Basic information
Public title
Investigation of factors associated with changes in urinary albumin when SGLT2 inhibitor, tofogliflozin, is initially administered or readministered to type 2 diabetic patients with stage 2-3 diabetic nephropathy
Acronym
Investigation of factors associated with changes in urinary albumin when SGLT2 inhibitor, tofogliflozin, is administered to type 2 diabetic patients with nephrpathy
Scientific Title
Subanalysis of RESTORE-nephropathy study (the research to explore the effects of a SGLT2 inhibitor, tofogliflozin, on renal protection estimated by first administration and readministration in patients with stage 2-3 diabetic nephropathy)
Scientific Title:Acronym
Subanalysis of RESTORE-nephropathy study
Region
| Japan |
Condition
Condition
Stage 2-3 diabetic nephropathy
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of initially administered and readministered sodium glucose cotransporter-2 (SGLT2) inhibitor, tofogliflozin, on urinary albumin in type 2 diabetic patients with stage 2-3 diabetic nephropathy. By using the dataset of RESTORE-nephropathy study, we investigate the relationship between the changes in urinary albumin and 2 fractions of urinary metanephrine (metanephrine and normetanephrine), which are the indicators of sympathetic nerve activity, caused by tofogliflozin administration.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between changes in 2 fractions of urinary metanephrine (metanephrine, normetanephrine) and nrinary albumin (creatinine conversion, UACR) from baseline (0 week) to 60th week.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals with type 2 diabetes mellitus and stage 2 or 3 diabetic nephropathy
Key exclusion criteria
Individuals with type 1 diabetes or secondary diabetes, individuals with a history of SGLT2 inhibitor use, individuals who started to use or changed the dose of angiotensin-converting enzyme inhibitors or angitotensin receptor blockers within 3 months before giving their informed consent.
Target sample size
47
Research contact person
Name of lead principal investigator
| 1st name | Masami |
| Middle name | |
| Last name | Tanaka |
Organization
Japan society for patient reported outcome/ Midtown clinic east
Division name
Not available
Zip code
101-0048
Address
2-15 Kanda Tsukasacho, chiyoda-ku, Tokyo
TEL
03-6626-5140
info@jpro.jp
Public contact
Name of contact person
| 1st name | Masami |
| Middle name | |
| Last name | Tanaka |
Organization
Japan society for patient reported outcome
Division name
Not available
Zip code
101-0048
Address
2-15 Kanda Tsukasacho, chiyoda-ku, Tokyo
TEL
03-6626-5140
Homepage URL
info@jpro.jp
Sponsor or person
Institute
Japan society for patient reported outcome
Institute
Department
Personal name
Funding Source
Organization
KOWA COMPANY, LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Physicians Association Institutional Review Board
Address
Kudan Kaikan Terrace 1F, Kudan-minami1-6-5 Chiyoda, Tokyo, 102-0074, Japan
Tel
03-3259-6111
irb@nichirinnai.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
071-2602-03
Org. issuing International ID_1
Japan Physicians Association Institutional Review Board
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 | 05 | Month | 01 | 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
| 2026 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The effects of initially administered and readministered sodium glucose cotransporter-2 (SGLT2) inhibitor, tofogliflozin, on urinary albumin in type 2 diabetic patients with stage 2-3 diabetic nephropathy are investigated. By using the dataset of RESTORE-nephropathy study, we investigate the relationship between the changes in urinary albumin and 2 fractions of urinary metanephrine (metanephrine and normetanephrine), which are the indicators of sympathetic nerve activity, caused by tofogliflozin administration.
Management information
Registered date
| 2026 | Year | 04 | Month | 21 | Day |
Last modified on
| 2026 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070157
