UMIN-CTR Clinical Trial

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
Email	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
Email	seigosugiyama@jinnouchi.or.jp

Sponsor
Institute	Jinnouchi Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045509