![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
![]() |
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 |
Basic information | ||
Public title | DAPA-BODY Trial | |
Acronym | DAPA-BODY Trial | |
Scientific Title | DAPA-BODY Trial | |
Scientific Title:Acronym | DAPA-BODY Trial | |
Region |
|
Condition | ||
Condition | chronic kidney disease | |
Classification by specialty |
|
|
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 |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 |
|
||||||
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 | |
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 |
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 |
|
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 |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
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 |