UMIN-CTR Clinical Trial

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
Email	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
Email	s1miyamoto@okayama-u.ac.jp

Sponsor
Institute	Okayama University Hospital
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033599