UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018711 |
|---|---|
| Receipt number | R000021628 |
| Scientific Title | The protective effect of canagliflozin on renal function in obese patients with T2DM |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2017/12/28 14:30:26 |
* 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
The protective effect of canagliflozin on renal function in obese patients with T2DM
Acronym
The protective effect of canagliflozin on renal function in obese patients with T2DM
Scientific Title
The protective effect of canagliflozin on renal function in obese patients with T2DM
Scientific Title:Acronym
The protective effect of canagliflozin on renal function in obese patients with T2DM
Region
| Japan |
Condition
Condition
Obese T2DM with nephropathy
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the protective effect of canagliflozin on renal function in obese patients with T2DM.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Change of eGFR slope
Key secondary outcomes
Blood evaluation: HbA1c, eGFR, serum Cr, cystatin C, Uriva acid, T-chol, HDL-chol, TG
Urine evaluation: ACR, 24hCCr, Urine volume, Na, K, Cl, L-FABP, B2-Mg, NAG, glucose and protein
Blood pressure at office
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Addition of canagliflozin (100mg once daily) to standard therapy for one year.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Obtained written informed consent
2) Patients who eligible to following criteria; ACR > 30mg/gCr, eGFR > 45ml/min/1.73m2, BMI > 25 Kg/m2 or waist circumference > 85cm (men) 90cm (women), HbA1c 6.5-9.0% (NGSP)
3) Patients who wasnot prescribed SGLT2 inhibitors for more than 3 months at entry.
4) Patients who can visit the hospital throughout the study.
Key exclusion criteria
1) HbA1C >9.0%
2) Allergy to canagliflozin
3) Severe ketoacidosis or diabetic coma
4) severe infection, operation, and trauma
5)T1DM
6) Moderate to severe renal disfuction (eGFR <45ml/min/1.73m2)
7) Heart failure (NYHA IV)
8) possibility of hypoglycemia by canagliflozine such as hypopituitarism, adrenal insuficiency, excessive exercise, malnutition, excess alcohol intake.
9) Dehydration
10) severe liver disfunction (AST and ALT > 5 x normal range of the hospital)
11) Age more than 70 years
12) Age less than 20 years
13) Pregnant or breastfeeding mother
14) patients who was regarded as uneligible by the doctor
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuichi Tsuruoka |
Organization
Nippon Medical School
Division name
Division of Nephrology
Zip code
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131(ext6496)
tsuruoka@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuichi Tsuruoka |
Organization
Nippon Medical School
Division name
Division of Nephrology
Zip code
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131(ext6496)
Homepage URL
tsuruoka@nms.ac.jp
Sponsor or person
Institute
Division of Nephrology, Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
日本医科大学付属病院（東京都）、東京慈恵会医科大学附属病院 （東京都）、東京医科大学病院（東京都）、自治医科大学附属病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 01 | 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 | 08 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 18 | Day |
Last modified on
| 2017 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021628
