UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055030 |
|---|---|
| Receipt number | R000062868 |
| Scientific Title | New Observational study on tofogliflozin as the MOst suitable approach to REcurrent urinary tract STONEs in patients with type 2 diabetes mellitus (NO MORE STONE trial) |
| Date of disclosure of the study information | 2024/07/20 |
| Last modified on | 2024/08/01 10:51:08 |
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Basic information
Public title
New Observational study on tofogliflozin as the MOst suitable approach to REcurrent urinary tract STONEs in patients with type 2 diabetes mellitus (NO MORE STONE trial)
Acronym
Observational study on tofogliflozin to recurrent urinary tract stones in patients with type 2 diabetes mellitus (NO MORE STONE trial)
Scientific Title
New Observational study on tofogliflozin as the MOst suitable approach to REcurrent urinary tract STONEs in patients with type 2 diabetes mellitus (NO MORE STONE trial)
Scientific Title:Acronym
New Observational study on tofogliflozin as the MOst suitable approach to REcurrent urinary tract STONEs in patients with type 2 diabetes mellitus (NO MORE STONE trial)
Region
| Japan |
Condition
Condition
Type 2 diabetic patients with a history of urinary tract stones
Classification by specialty
| Endocrinology and Metabolism | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of tofogliflozin, an SGLT2 inhibitor, on recurrent urinary tract stones in type 2 diabetic patients with a history of urinary tract stones
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cumulative 96-week urinary tract stone recurrence rate
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patient has been diagnosed with type 2 diabetes mellitus.
2.Patient is scheduled to receive a new administration of tofogliflozin because the patient has failed to meet the glycemic control goals specified in the Diabetes Treatment Guide 2022-2023 despite treatment with diet and exercise therapy or treatment with diabetes medications in addition to diet and exercise therapy for at least 12 weeks.
3.Patient is at least 18 years of age at the time of consent.
4.Patient has urinary tract stones [excluding lower urinary tract stones (bladder stones and urethral stones)] within 5 years.
5.No urinary tract stones (no stones) on CT within 12 weeks prior to obtaining consent.
6.Written consent to participate in the research has been obtained from the individual.
Key exclusion criteria
1. Patients with a history of hypersensitivity to any component of tofogliflozin
2. Patients with a history of taking SGLT2 inhibitors within 12 weeks prior to obtaining consent
3. Patients with severe ketosis, diabetic coma or pre-coma
4. Patients with severe infection, perioperative, or severe trauma
5. Patients with type 1 diabetes mellitus
6. Patients with extremely poor glycemic control (HbA1c > 10%)
7. Pregnant, lactating, possibly pregnant or planning to become pregnant
8. Patients with malignant tumors or with a history of malignant tumors (except for patients who are not currently receiving treatment for malignant tumors and have no evidence of recurrence, and patients who can be judged not to have recurred during the study period)
9. Patients with end-stage renal failure (eGFR less than 15 mL/min/1.73m2)
10. Patients with a history of urinary tract and genital tract infection within 1 year
11. Patients who have been determined to be unsuitable as a subject by a physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Go |
| Middle name | |
| Last name | Anan |
Organization
Yotsuya Medical Cube
Division name
Urology
Zip code
1020084
Address
7-7 Nibancho, Chiyoda-ku, Tokyo
TEL
03-3261-0401
g-anan@mcube.jp
Public contact
Name of contact person
| 1st name | Go |
| Middle name | |
| Last name | Anan |
Organization
Yotsuya Medical Cube
Division name
Urology
Zip code
1020084
Address
7-7 Nibancho, Chiyoda-ku, Tokyo
TEL
03-3261-0401
Homepage URL
g-anan@mcube.jp
Sponsor or person
Institute
Clinical Research Management Department, Yotsuya Medical Cube
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
Iida Clinic, Kitasaito Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Management Department, Yotsuya Medical Cube
Address
7-7 Nibancho, Chiyoda-ku, Tokyo
Tel
03-3261-0401
ymc_rinsyou@mcube.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
| 2024 | Year | 07 | Month | 20 | 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
| 2024 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients will be started on tofogliflozin, an SGLT2 inhibitor, and will be monitored for recurrence of urinary tract stones at 4, 24, 48, and 96 weeks for blood sampling, urine analysis, CT scan and X-rays every 48 weeks, and physical findings (sudden back pain and hematuria) at each visit as in the usual medical practice.
Management information
Registered date
| 2024 | Year | 07 | Month | 20 | Day |
Last modified on
| 2024 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062868
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