UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020710 |
|---|---|
| Receipt number | 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 11:50:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
ayumi.m0106@z7.keio.jp
Sponsor or person
Institute
Keio University, School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
