UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049848 |
|---|---|
| Receipt number | R000056783 |
| Scientific Title | Influence of SGLT2 inhibitors on the efficiency of peritoneal dialysis |
| Date of disclosure of the study information | 2023/01/26 |
| Last modified on | 2024/08/03 07:58:41 |
* 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
Influence of SGLT2 inhibitors on the efficiency of peritoneal dialysis
Acronym
SGLT2 inhibitors in PD
Scientific Title
Influence of SGLT2 inhibitors on the efficiency of peritoneal dialysis
Scientific Title:Acronym
SGLT2 inhibitors in PD
Region
| Japan |
Condition
Condition
Chronic kidney disease under peritoneal dialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the possible influence of SGLT2 inhibitors on the efficiency of peritoneal dialysis.
Basic objectives2
Others
Basic objectives -Others
Sugar level in the peritoneal dialysate
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
peritoneal equilibration test on the day of administration
Key secondary outcomes
Blood sugar level on the day of administration
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of SGLT2 inhibitors
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
Chronic kidney disease patients under peritoneal dialysis
Key exclusion criteria
Peritonitis or intraperitoneal cancers
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Tanemoto |
Organization
International University of Health and Welfare
Division name
Nephrology
Zip code
413-0012
Address
13-1 Higashi-Kaigan-Cho, Atami
TEL
0557819171
mtanemoto-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Tanemoto |
Organization
International University of Health and Welfare
Division name
Nephrology
Zip code
413-0012
Address
13-1 Higashi-Kaigan-Cho, Atami
TEL
0557819171
Homepage URL
mtanemoto-tky@umin.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Self
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare Atami Hospital
Address
13-1 Higashi-Kaigan-Cho, Atami
Tel
0557819171
na-ayumi@iuhw.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
| 2023 | Year | 01 | 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
Completed
Date of protocol fixation
| 2023 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 01 | 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
| 2022 | Year | 12 | Month | 21 | Day |
Last modified on
| 2024 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056783
