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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036183
Receipt No. R000041225
Scientific Title Mechanism and efficacy of SGLT2 inhibitor in diabetes patients with renal anemia
Date of disclosure of the study information 2019/03/15
Last modified on 2019/03/14

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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
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
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

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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