UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029905 |
|---|---|
| Receipt number | R000033599 |
| Scientific Title | Effect of canagliflozin in type 2 diabetic patients with microalbuminuria in Japanese population |
| Date of disclosure of the study information | 2017/11/21 |
| Last modified on | 2020/05/14 13:43:32 |
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Basic information
Public title
Effect of canagliflozin in type 2 diabetic patients with microalbuminuria in Japanese population
Acronym
CANPIONE study
Scientific Title
Effect of canagliflozin in type 2 diabetic patients with microalbuminuria in Japanese population
Scientific Title:Acronym
CANPIONE study
Region
| Japan |
Condition
Condition
Type 2 diabetes with microalbuminuria
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to assess the renoprotective effect of canagliflozin compared with treatment with drugs other than SGLT2 inhibitor on early stage of diabetic nephropathy in patients with type 2 diabetes mellitus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Change in urinary albumin to creatinine ratio (ACR) from baseline to week 52 in the intervention period
2. Change in eGFR slope
Key secondary outcomes
1. Change in eGFR from baseline to the end of the washout period
2. Progression to macroalbuminuria
3. Regression to normoalbuminuria
4. Change in eGFR from week 52 to the end of washout period
5. Change in urinary ACR from baseline to each visit in the intervention period
6. Comparison of change in urinary ACR by canagliflozin between participants taking ACE inhibitor and/or ARB and participants taking neither ACE inhibitor nor ARB
7. Changes in HbA1c, body mass index, and blood pressure
8. Occurrence of cardiovascular event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Canagliflozin treatment group:
Participants assigned to canagliflozin treatment will take a canagliflozin 100 mg tablet once daily for 52 weeks
Interventions/Control_2
Control group:
Participants assigned to the control group will receive treatment with drugs other than SGLT2 inhibitor for 52 weeks
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Man or woman with a diagnosis of type 2 diabetes
2. Age >= 20 to < 75 years at time of informed consent
3. Glycated hemoglobin (HbA1c) >= 7.0 % and < 11.0% at visit 1
4. Geometric mean of 2 first morning voided urinary albumin-to-creatinine ratio >= 50 to < 300 mg/gCr at visit 2 and visit 3
5. Estimated glomerular filtration rate (eGFR) >= 45 mL/min per 1.73m2 at visit 1
6. All subjects are required to have signed an informed consent document indicating that they understood the purpose of and procedures required for the study and are willing to participate in the study
Key exclusion criteria
1. Use of SGLT2 inhibitor <= 12 weeks prior to informed consent
2. Known allergies or hypersensitivity to canagliflozin or other SGLT2 inhibitors
3. History of severe diabetic ketosis (including ketoacidosis), diabetic coma or pre-coma
4. Severe infection, pre- or post-surgery (ie, requiring general anesthesia) or severe trauma at time of informed consent or visit 3
5. Urinary tract infection or genital infection at time of informed consent or visit 3
6. Underlying renal disease other than diabetic nephropathy at time of informed consent or visit 3
7. New York Heart Association Class IV cardiac disease at time of informed consent or visit 3
8. Severe hypertension (systolic blood pressure >= 180 mmHg and/or diastolic blood pressure >= 110 mmHg) at time of informed consent or visit 3
9. History of arteriosclerosis obliterans and/or foot ulcer and/or limb amputation
10. Pregnant, possibly pregnant, breast-feeding or planning to become pregnant during the study
11. Medical history of cancer and/or treatment for cancer within the last 5 years at time of informed consent or visit 3
12. Severe liver disease at time of informed consent or visit 3
13. Treatment with systemic steroids at time of informed consent or visit 3
14. Treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) at time of informed consent or visit 3
15. Reduction in eGFR >= 30% from visit 1 to visit 3
16. Any condition that, in the opinion of the investigator, would compromise the subject's well-being or ability to perform the study requirements
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Shikata |
Organization
Okayama University Hospital
Division name
Center for Innovative Clinical Medicine
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
086-235-6508
shikata@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Miyamoto |
Organization
Okayama University Hospital
Division name
Center for Innovative Clinical Medicine
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
086-235-6510
Homepage URL
s1miyamoto@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
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
岡山大学病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 21 | 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
| 2017 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study was registered to Japan Registry of Clinical Trials (jRCT) and released on March 12, 2019 in accordance with the Clinical Trial Act. For latest information about the study, please refer to the the information in jRCT (jRCTs061180047).
Management information
Registered date
| 2017 | Year | 11 | Month | 10 | Day |
Last modified on
| 2020 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033599
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
