UMIN-CTR Clinical Trial

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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