Diabetic NephropathyPhase 3NCT03436693

Efficacy and Safety of Canagliflozin (TA-7284) in Patients With Diabetic Nephropathy

A Phase 3 study testing Canagliflozin in people with Diabetic Nephropathy, run by Tanabe Pharma Corporation at 26 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the efficacy and safety of Canagliflozin (TA-7284) in Japanese patients with Diabetic Nephropathy, compared with placebo Read more about this study

Who is it for?: Ages 30 years and older
Conditions the study is for: Diabetic Nephropathy
What is being tested?: Canagliflozin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 308 participants
Where: 26 sitesJapan
Study dates: 15 Feb 2018to 21 Jan 2021
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Additional criteria check may apply for qualification:
Glycated hemoglobin(HbA1c) of ≥6.5% and ≤12.0%
eGFR of ≥30 mL/min/1.73m2 and <90 mL/min/1.73m2
The median UACR of the first morning void urine samples is ≥300 mg/g Cr and ≤5000 mg/g Cr
Patients who are taking on angiotensin-converting enzyme inhibitor (ACE-I) or angiotensin receptor blocker (ARB)
Patients who are under dietary management and taking therapeutic exercise for diabetes

Who cannot join

Additional criteria check may apply for qualification:
Type I diabetes, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes
A diagnosis of non-diabetic renal disease
Hereditary glucose-galactose malabsorption or primary renal glucosuria
Class IV heart failure symptoms according to New York Heart Association (NYHA) functional classification
Severe hepatic disorder or severe renal disorder
Blood potassium level >5.5 mmoL/L
Stable blood pressure (diastolic blood pressure (DBP) ≥100mmHg or systolic blood pressure (SBP) ≥180mmHg)

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

Japan26 sites

Research site
Aichi
Research site
Chiba
Research site
Fukuoka
Research site
Fukushima
Research site
Gunma
Research site
Hiroshima
Research site
Hokkaido
Research site
Hyōgo
Research site
Ibaraki
Research site
Kagawa
Research site
Kagoshima
Research site
Kanagawa
Research site
Kumamoto
Research site
Mie
Research site
Nagano
Research site
Nagasaki
Research site
Ōita
Research site
Okinawa
Research site
Osaka
Research site
Saitama
Research site
Shizuoka
Research site
Tochigi
Research site
Tokyo
Research site
Wakayama
Research site
Yamagata
Research site
Yamaguchi

Other trials in Japan

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Canagliflozin (TA-7284) in Patients With Diabetic Nephropathy

The purpose of this study is to evaluate the efficacy and safety of Canagliflozin (TA-7284) in Japanese patients with Diabetic Nephropathy, compared with placebo

Conditions: Diabetic Nephropathy
Being tested: Canagliflozin, Placebo
Keywords: Diabetic Nephropathy, Canagliflozin, Canaglu, Diabetes Mellitus, Type 2
Medical subject headings: Diabetic Nephropathies, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CanagliflozinDrug
Also called TA-7284, Canaglu
Canagliflozin 100mg orally once daily
PlaceboDrug
Placebo orally once daily

Study groups in NCT03436693
Study group	Role	What they receive
Canagliflozin 100mg	Experimental	Not described Receives: Drug: Canagliflozin
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With 30% Decline in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Week 104
Percentage of participants with 30% decline in eGFR was calculated by multiple imputation method for missing data.
Measured: Week 104

Secondary outcomes (4)

Percentage of Participants With 40% Decline in eGFR From Baseline at Week 104
Percentage of participants with 40% decline in eGFR was calculated by multiple imputation method for missing data.
Measured: Week 104
Change From Baseline in eGFR at Week 104
Measured: Baseline and Week 104
Composite Endpoint of End-stage Renal Disease (ESRD), Doubling of Serum Creatinine, Renal Death, and Cardiovascular (CV) Death
Measured: up to approximately 108 weeks
Change From Baseline in Percentage of Urine Albumin-to -Creatinine Ratio (UACR) at Week 104
Measured: Baseline and Week 104

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 201821 Jan 2021

First posted19 Feb 2018
Study start15 Feb 2018
Primary completion21 Jan 2021
Study completion21 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 308 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03436693
Sponsor's protocol ID: TA-7284-14
Status last verified: Dec 2025
First submitted: 1 Feb 2018
Last updated: 7 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Publications

Wada T, Mori-Anai K, Takahashi A, Matsui T, Inagaki M, Iida M, Maruyama K, Tsuda H. Effect of canagliflozin on the decline of estimated glomerular filtration rate in chronic kidney disease patients with type 2 diabetes mellitus: A multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase III study in Japan. J Diabetes Investig. 2022 Dec;13(12):1981-1989. doi: 10.1111/jdi.13888. Epub 2022 Aug 9.
PubMed 35861630
Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
PubMed 38770818

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetic Nephropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Canagliflozin (TA-7284) in Patients With Diabetic Nephropathy
ClinicalTrials.gov ID: NCT03436693
Acronym / sponsor ID: TA-7284-14
Conditions: Diabetic Nephropathy
Keywords: Diabetic Nephropathy, Canagliflozin, Canaglu, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 308 participants (actual)
Lead sponsor: Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
Study start: 15 Feb 2018 (actual)
Primary completion: 21 Jan 2021 (actual)
Study completion: 21 Jan 2021 (actual)
First posted: 19 Feb 2018 (actual)
Results: Posted 15 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the efficacy and safety of Canagliflozin (TA-7284) in Japanese patients with Diabetic Nephropathy, compared with placebo

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Canagliflozin 100mg	Experimental	Drug: Canagliflozin
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 30 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Glycated hemoglobin(HbA1c) of ≥6.5% and ≤12.0%
eGFR of ≥30 mL/min/1.73m2 and <90 mL/min/1.73m2
The median UACR of the first morning void urine samples is ≥300 mg/g Cr and ≤5000 mg/g Cr
Patients who are taking on angiotensin-converting enzyme inhibitor (ACE-I) or angiotensin receptor blocker (ARB)
Patients who are under dietary management and taking therapeutic exercise for diabetes

Key exclusion criteria (8 listed)

Type I diabetes, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes
A diagnosis of non-diabetic renal disease
Hereditary glucose-galactose malabsorption or primary renal glucosuria
Class IV heart failure symptoms according to New York Heart Association (NYHA) functional classification
Severe hepatic disorder or severe renal disorder

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CanagliflozinAlso: TA-7284, CanagluCanagliflozin 100mg orally once daily	Drug	Canagliflozin 100mg
PlaceboPlacebo orally once daily	Drug	Placebo

Primary outcome

Percentage of Participants With 30% Decline in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Week 104
Time frame: Week 104
Percentage of participants with 30% decline in eGFR was calculated by multiple imputation method for missing data.

4 secondary outcomes

Percentage of Participants With 40% Decline in eGFR From Baseline at Week 104
Time frame: Week 104
Change From Baseline in eGFR at Week 104
Time frame: Baseline and Week 104
Composite Endpoint of End-stage Renal Disease (ESRD), Doubling of Serum Creatinine, Renal Death, and Cardiovascular (CV) Death
Time frame: up to approximately 108 weeks
Change From Baseline in Percentage of Urine Albumin-to -Creatinine Ratio (UACR) at Week 104
Time frame: Baseline and Week 104

Results and safety

Results posted to the registry on 15 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Canagliflozin 100mg	154	124
Placebo	154	127

Primary outcome: Percentage of Participants With 30% Decline in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Week 104

Time frame: Week 104. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	Canagliflozin 100mg n = 154	Placebo n = 154
Value	18.2 (11.7 to 24.8)	29.5 (21.9 to 37.2)

Canagliflozin 100mg vs Placebo: Difference(Multiple imputation method): 11.3 (95% CI 1.2 to 21.5)

Population analysed: Full Analysis Set. All Patients were analyzed according to their randomized treatment assignment.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to approximately 108 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Canagliflozin 100mg	43 of 154 (27.9%)	106 of 154 (68.8%)	4 of 154
Placebo	33 of 154 (21.4%)	106 of 154 (68.8%)	2 of 154

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 35861630Wada T, Mori-Anai K, Takahashi A, Matsui T, Inagaki M, Iida M, Maruyama K, Tsuda H. Effect of canagliflozin on the decline of estimated glomerular filtration rate in chronic kidney disease patients with type 2 diabetes mellitus: A multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase III study in Japan. J Diabetes Investig. 2022 Dec;13(12):1981-1989. doi: 10.1111/jdi.13888. Epub 2022 Aug 9.
Derived from this study: PubMed 38770818Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.

Related trials for Diabetic Nephropathy

Not yet recruitingObservational study
Beta-2-Trace Protein in Diabetic Nephropathy
Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus
Active, not recruitingObservational study
Family Investigation of Nephropathy and Diabetes (F.I.N.D.)
Diabetic Nephropathy, Diabetes Mellitus
Active, not recruitingPhase 4
Pentoxifylline in Diabetic Kidney Disease
Diabetic Kidney Disease
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Not yet recruitingObservational study
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

General Manager study director

Tanabe Pharma Corporation

26 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Canagliflozin in people with Diabetic Nephropathy, run by Tanabe Pharma Corporation at 26 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With 30% Decline in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Week 104 (time frame: Week 104). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03436693, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.