UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048568 |
|---|---|
| Receipt number | R000055337 |
| Scientific Title | DAPA-BODY Trial |
| Date of disclosure of the study information | 2022/08/04 |
| Last modified on | 2022/08/03 16:49:54 |
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Basic information
Public title
DAPA-BODY Trial
Acronym
DAPA-BODY Trial
Scientific Title
DAPA-BODY Trial
Scientific Title:Acronym
DAPA-BODY Trial
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the long-term effect of SGLT2 inhibitor dapagliflozin on body composition in chronic kidney disease patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
body composition (body fluid volume, fat mass, bone mineral content, and skeletal muscle mass) for 6 and 12 months after the administration of dapagliflozin
Key secondary outcomes
changes in hemodynamic parameters and eGFR for 6 and 12 months after the administration of dapagliflozin
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
SGLT2 inhibitor dapagliflozin 10 mg/day for 12 months
Interventions/Control_2
Treatment without SGLT2 inhibitor dapagliflozin for 12 months
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
CKD patients with or without diabetes
-15 < eGFR < 59 mL/min/1.73 m2 with or without proteinuria
-60 < eGFR mL/min/1.73 m2 with proteinuria
Key exclusion criteria
1. History of renal replacement
2. Current dialysis
3. Type 1 diabetic mellitus
4. Active malignancy
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
3311-1 Yakushiji, Shimotsuke, Tochigi
TEL
0285587346
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
0285587346
Homepage URL
takamasu35@gmail.com
Sponsor or person
Institute
JichiMedical University
Institute
Department
Personal name
Funding Source
Organization
The Kidney Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Shin-Oyama City Hospital, Nasu Minami Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shin-Oyama Hospital
Address
2251-1 Hitotonoya, Oyama, Tochigi
Tel
0285-36-0200
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
新小山市民病院、那須南病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 04 | 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
100
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 13 | 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
| 2022 | Year | 08 | Month | 03 | Day |
Last modified on
| 2022 | 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=R000055337
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
