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Name
UMIN ID

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000048568
Receipt No. R000055337
Scientific Title DAPA-BODY Trial
Date of disclosure of the study information 2022/08/04
Last modified on 2022/08/03

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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
Email 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
Email takamasu35@gmail.com

Sponsor
Institute JichiMedical University
Institute
Department

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
Email 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
URL(English) 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
Registered date File name

Research case data
Registered date File name


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