UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of SGLT2 inhibitor
Acronym	Efficacy of SGLT2 inhibitor
Scientific Title	Mechanism and efficacy of SGLT2 inhibitor in diabetes patients with renal anemia
Scientific Title:Acronym	SGLT2 inhibitor and renal anemia
Region	Japan

Condition
Condition	Diabetic nephropathy
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the mechanism of hemopoiesis by SGLT2 inhibitor
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hemoglobin concentration, erythropoietin concentration
Key secondary outcomes	albuminuria, eGFR, urinary biomarkers

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Canagliflozin 100mg daily, 12 weeks
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Type 2 diabetes (HbA1c<10.0%) 2. eGFR > 45 mL/min/1.73m2 3. Albuminuria > 30mg/gCr 4. Hb < 13.5g/dL 5. Age > 19 years old
Key exclusion criteria	1. Intotelance for SGLT2 inhibitors 2. Past history of SGLT2 inhibitor before to 4 weeks at enrollment 3. Past history of administration of ESA before 12 weeks at enrollment 4. Ftn <50 ng/mL and TSAT <20% 5. HbA1c > 10.0% 6. Type 1 diabetes 7. eGFR<45mL/min/1.73m2 8. Pregnancy 9. alchol misuse 10. Severe ketosis, infection, and coma
Target sample size	10

Research contact person
Last name of lead principal investigator	1st name Masanori Middle name Last name Abe
Organization	Nihon University Itabashi Hospital
Division name	Nephrology, Hypertension and Endocrinology
Zip code	173-8610
Address	30-1, Oyaguchi Kami-cho, Itabashi-ku, Tokyo, Japan
TEL	03-3972-8111
Email	abe.masanori@nihon-u.ac.jp

Public contact
1st name of contact person	1st name Masanori Middle name Last name Abe
Organization	Nihon University Itabashi Hospital
Division name	Nephrology, Hypertension and Endocrinology
Zip code	173-8610
Address	30-1, Oyaguchi Kami-cho, Itabsahi-ku, Tokyo, Japan
TEL	03-3972-8111
Homepage URL
Email	abe.masanori@nihon-u.ac.jp

Sponsor
Institute	Nihon University Itabashi Hospital
Institute
Department

Funding Source
Organization	Tanabe Mitsubishi Pharm Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Nihon University Itabashi Hospital
Address	30-1, Oyaguchi Kami-cho, Itabashi-ku, Tokyo, Japan
Tel	03-3972-8111
Email	abe.masanori@nihon-u.ac.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	2019 Year 03 Month 15 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	9
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	Completed
Date of protocol fixation	2018 Year 08 Month 07 Day
Date of IRB	2018 Year 03 Month 26 Day
Anticipated trial start date	2018 Year 10 Month 01 Day
Last follow-up date	2019 Year 03 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 03 Month 13 Day
Last modified on	2019 Year 03 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041225