UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039903 |
|---|---|
| Receipt number | R000045509 |
| Scientific Title | Retrospective study of Initial Acute Decline in eGFR after SGLT2-inhibitor Therapy in Patients with Type-2 Diabetes Mellitus and CKD Stage-3b |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2021/03/24 10:34:40 |
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Basic information
Public title
Retrospective study of Initial Acute Decline in eGFR by SGLT2-inhibitor
Acronym
Retrospective study of IAD-eGFR by SGLT2i
Scientific Title
Retrospective study of Initial Acute Decline in eGFR after SGLT2-inhibitor Therapy in Patients with Type-2 Diabetes Mellitus and CKD Stage-3b
Scientific Title:Acronym
Retrospective study of IAD-eGFR by SGLT2i in T2DM and CKD 3b
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We retrospectively investigated the IAD-eGFR caused by starting SGLT2i-therapy in T2DM patients with CKD Stage-3b in a real clinical setting.
Basic objectives2
Others
Basic objectives -Others
Effect of IAD-eGFR on eGFR at 6months after SGLT2i-therapy
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We retrospectively investigated how much and how frequently IAD-eGFR occurs in T2DM patients with CKD Stage-3b in the real clinical practice.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
T2DM
CKD 3b
SGLT2i therapy for more than 6 months
Key exclusion criteria
Type 1 DM
unstable condition
cancer
infection
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Seigo |
| Middle name | |
| Last name | Sugiyama |
Organization
Jinnouchi Hospital
Division name
Diabetes Care Center
Zip code
862-0976
Address
6-2-3, Kuhonji Chuo-ku, Kumamoto-City, Kumamoto Japan
TEL
096-363-0011
seigosugiyama@jinnouchi.or.jp
Public contact
Name of contact person
| 1st name | Seigo |
| Middle name | |
| Last name | Sugiyama |
Organization
Jinnouchi Hospital
Division name
Diabetes Care Center
Zip code
862-0976
Address
6-2-3, Kuhonji Chuo-ku, Kumamoto-City, Kumamoto Japan
TEL
096-363-0011
Homepage URL
seigosugiyama@jinnouchi.or.jp
Sponsor or person
Institute
Jinnouchi Hospital
Institute
Department
Personal name
Funding Source
Organization
Jinnouchi Hospital
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
IRB in Jinnouchi Hospital
Address
6-2-3, Kuhonji Chuo-ku, Kumamoto-City, Kumamoto Japan
Tel
096-636-0011
akira.y@jinnouchi.or.jp
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://doi.org/10.14740/jocmr4351
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.14740/jocmr4351
Number of participants that the trial has enrolled
87
Results
The mean minimum eGFR early after SGLT2i administration was 34.9 mL/min/1.73 m2, which was significantly lower than before treatment (mean, -7.7%). Seventy patients (80.5%) had IAD-eGFR, and 36 patients (41.4%) had a large IAD-eGFR (more than10%).
Results date posted
| 2021 | Year | 03 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We retrospectively recruited T2DM patients with CKD (stage-3b) and who were newly treated with add-on SGLT2i.
Participant flow
We investigated the effects of SGLT2i therapy on eGFR early after starting treatment (1 to 3 months) and after 6 months of treatment.
Adverse events
No adverse events
Outcome measures
the effects of SGLT2i therapy on eGFR early after starting treatment (1 to 3 months) and after 6 months of treatment.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Results will be presented at JDS 2020.
Management information
Registered date
| 2020 | Year | 03 | Month | 23 | Day |
Last modified on
| 2021 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045509
