UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029863 |
|---|---|
| Receipt number | R000034108 |
| Scientific Title | SGLT2 and fluid control study |
| Date of disclosure of the study information | 2017/11/10 |
| Last modified on | 2022/11/15 19:26:38 |
* 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
SGLT2 and fluid control study
Acronym
SGF Study
Scientific Title
SGLT2 and fluid control study
Scientific Title:Acronym
SGF Study
Region
| Japan |
Condition
Condition
Chronic kidney disease including diabetic kidney disease
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to evaluate fluid volume, renal and cardiac function after the administration of SGLT2 inhibitors, loop diuretics and vasopressin V2 receptor antagonist
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fluid volume (intracellular water and extracellular water) after 1 week, 6 months and 1 year
Key secondary outcomes
Renal function and cardiac function after 6 months and 1 year
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Chronic kidney disease patients indluding diabetic kidney disease with fluid retention
Key exclusion criteria
Patients without peripheral edema, active
malignancy, hemodialysis, peritoneal dialysis, patients taking some SGLT2 inhibitor and failure to cooperate with the study or provide consent to participate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | TAKAHIRO |
| Middle name | |
| Last name | MASUDA |
Organization
Jichi Medical University
Division name
Division of Nephrology, Department of Internal Medicine
Zip code
3290498
Address
Shimotsuke
TEL
0286122480
takamasu35@gmail.com
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Masuda |
Organization
Jichi Medical University
Division name
Division of Nephrology, Department of Internal Medicine
Zip code
3290498
Address
3311-1 Yakushiji, Shimotsuke, Tochigi
TEL
0285-58-7346
Homepage URL
takamasu35@gmail.com
Sponsor or person
Institute
Division of Nephrology, Department of Internal Medicine, Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Division of Nephrology, Department of Internal Medicine, Jichi Medical University
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
Jichi Medical University
Address
3311-1 Yakushiji
Tel
0285442111
takamasu35@gmail.com
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
自治医科大学附属病院、那須南病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 10 | 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
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients entry finished.
Management information
Registered date
| 2017 | Year | 11 | Month | 07 | Day |
Last modified on
| 2022 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034108
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
