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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000020710
Receipt No. R000023897
Scientific Title Effects of Canagliflozin on microbiota and glycometabolism, kidney function of patients with diabetic nephropathy
Date of disclosure of the study information 2016/01/23
Last modified on 2018/03/23

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Basic information
Public title Effects of Canagliflozin on microbiota and glycometabolism, kidney function of patients with diabetic nephropathy
Acronym Effects of Canagliflozin on patients with diabetic nephropathy
Scientific Title Effects of Canagliflozin on microbiota and glycometabolism, kidney function of patients with diabetic nephropathy
Scientific Title:Acronym Effects of Canagliflozin on patients with diabetic nephropathy
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study is to investigate the effect of Canagliflozin on the microbiome and how the alteration of the microbiome affects glycometabolism and renal function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes the microbiome of patients with diabetic nephropaty
Key secondary outcomes

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 per day taken orally for 1year
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1.patients with diabetic nephropathy which is worse than stage2
2.eGFR higher than 45ml/min/1.73m2
3.free of kidney disease other than diabetic nephropathy
4.HbA1c higher than 6.5 percent and lower than 10.0 percent
5.patients who are on 8weeks of dietary cure and exercise therapy before the study, or patients who are taking oral diabetic medicine other than Canagliflozin
6.patients who recieved enough explanation to understand about the study and signed on the agreement document by whose own will

Key exclusion criteria 1.patiens whose eGFR declined more than 25% during the observation period
2.patients with fasting blood glucose higher than 250mg/dl
3.patients who has been on dialysis or who went through renal transplantation
4.patients with type 1 diabetes or secondary diabetes
5.patients who has taken other investigational drugs within 3months of the beginning of this study
6.patients who fall under contraindication of Canagliflozin
7.patients whom the doctor decided unsuitable for the study
Target sample size 33

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shu Wakino
Organization Keio University, School of Medicine
Division name Division of Endocrinology, Metabolism and Nephrology Department of Internal Medicine
Zip code
Address Shinanomachi 35, shinjyuku-ku, Tokyo, Japan
TEL 0333531211
Email shuwakino@z8.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ayumi Matsui
Organization Keio University, School of Medicine
Division name Division of Endocrinology, Metabolism and Nephrology Department of Internal Medicine
Zip code
Address Shinanomachi 35, shinjyuku-ku, Tokyo, Japan
TEL 03-3353-1211
Homepage URL
Email ayumi.m0106@z7.keio.jp

Sponsor
Institute Keio University, School of Medicine
Institute
Department

Funding Source
Organization Mitsubishi Tanabe Pharma
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
Address
Tel
Email

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 慶應義塾大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 23 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
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 Terminated
Date of protocol fixation
2015 Year 12 Month 04 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 10 Day
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
2016 Year 01 Month 23 Day
Last modified on
2018 Year 03 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023897

Research Plan
Registered date File name
2016/07/25 プロトコール1.1.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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