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CompletedNCT03436693Updated Jan 7, 2026Results posted

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

A Phase 3 interventional study of Canagliflozin and Placebo in Diabetic Nephropathy, sponsored by Tanabe Pharma Corporation. Completed at 26 sites in Japan. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2026-01-07.

Sponsored by Tanabe Pharma Corporation · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
308
Allocation
Randomized
Ages
30 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Diabetic Nephropathy

Keywords

  • Diabetic Nephropathy
  • Canagliflozin
  • Canaglu
  • Diabetes Mellitus, Type 2
03

Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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)
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
308 participants (actual)

Study arms

  • Experimental
    Canagliflozin 100mg

    Drug: Canagliflozin

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugCanagliflozin

    Canagliflozin 100mg orally once daily

    Also known as: TA-7284, Canaglu

  • DrugPlacebo

    Placebo orally once daily

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Week 104

Secondary outcomes

  1. 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.

    Time frame: Week 104

  2. Change From Baseline in eGFR at Week 104

    Time frame: Baseline and Week 104

  3. 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

  4. Change From Baseline in Percentage of Urine Albumin-to -Creatinine Ratio (UACR) at Week 104

    Time frame: Baseline and Week 104

06

Results

Posted Jul 15, 2024

Participant flow

Participant flow — Overall Study
MilestoneCanagliflozin 100mgPlacebo
Started154154
Completed124127
Not completed3027
Withdrew: Adverse event2210
Withdrew: Physician decision33
Withdrew: Withdrawal by subject413
Withdrew: Progressive disease11

Outcome measures

PrimaryPercentage 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.

Time frame:
Week 104
Reported as:
Number · Percentage of Participants
Percentage of Participants With 30% Decline in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Week 104
Percentage of ParticipantsCanagliflozin 100mgPlacebo
Percentage of Participants With 30% Decline in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Week 10418.2 (11.7 to 24.8)29.5 (21.9 to 37.2)
Statistical analysis
  • Canagliflozin 100mg vs Placebo · Difference(multiple imputation method): 11.3 · 95% CI 1.2 to 21.5
SecondaryPercentage 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.

Time frame:
Week 104
Reported as:
Number · percentage of Participants
Percentage of Participants With 40% Decline in eGFR From Baseline at Week 104
percentage of ParticipantsCanagliflozin 100mgPlacebo
Percentage of Participants With 40% Decline in eGFR From Baseline at Week 10410.1 (5.0 to 15.3)13.9 (8.0 to 19.9)
Statistical analysis
  • Canagliflozin 100mg vs Placebo · Difference(multiple imputation method): 3.8 · 95% CI -4.1 to 11.7
SecondaryChange From Baseline in eGFR at Week 104
Time frame:
Baseline and Week 104
Reported as:
Least squares mean · mL/min/1.73m^2
Change From Baseline in eGFR at Week 104
mL/min/1.73m^2Canagliflozin 100mgPlacebo
Change From Baseline in eGFR at Week 104-10.39 ± 0.83-11.49 ± 0.83
Statistical analysis
  • Canagliflozin 100mg vs Placebo · Mixed Models Analysis · p = 0.351 · Difference of lsmean: 1.09 · 95% CI -1.21 to 3.40
SecondaryComposite Endpoint of End-stage Renal Disease (ESRD), Doubling of Serum Creatinine, Renal Death, and Cardiovascular (CV) Death
Time frame:
up to approximately 108 weeks
Reported as:
Number · Event rate per 1000 patient-years
Composite Endpoint of End-stage Renal Disease (ESRD), Doubling of Serum Creatinine, Renal Death, and Cardiovascular (CV) Death
Event rate per 1000 patient-yearsCanagliflozin 100mgPlacebo
Composite Endpoint of End-stage Renal Disease (ESRD), Doubling of Serum Creatinine, Renal Death, and Cardiovascular (CV) Death24.2938.66
Statistical analysis
  • Canagliflozin 100mg vs Placebo · Regression, Cox · p = 0.293 · Hazard ratio (hr): 0.60 · 95% CI 0.23 to 1.55
SecondaryChange From Baseline in Percentage of Urine Albumin-to -Creatinine Ratio (UACR) at Week 104
Time frame:
Baseline and Week 104
Reported as:
Geometric least squares mean · percent change
Change From Baseline in Percentage of Urine Albumin-to -Creatinine Ratio (UACR) at Week 104
percent changeCanagliflozin 100mgPlacebo
Change From Baseline in Percentage of Urine Albumin-to -Creatinine Ratio (UACR) at Week 1040.612 (0.525 to 0.714)1.178 (1.010 to 1.373)
Statistical analysis
  • Canagliflozin 100mg vs Placebo · Mixed Models Analysis · p = <0.001 · Ratio of geometric lsmean: 0.52 · 95% CI 0.418 to 0.646

Adverse events

Collected over up to approximately 108 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Canagliflozin 100mg4/154 (2.6%)43/154 (27.9%)106/154 (68.8%)
Placebo2/154 (1.3%)33/154 (21.4%)106/154 (68.8%)
Most frequent serious events
Showing 10 of 73
Most frequent serious events
EventCanagliflozin 100mgPlacebo
CataractEye disorders9/1542/154
Myocardial infarctionCardiac disorders6/1541/154
Diabetic retinopathyEye disorders3/1540/154
GlaucomaEye disorders3/1540/154
Cardiac failure acuteCardiac disorders1/1542/154
Inguinal herniaGastrointestinal disorders0/1542/154
Large intestine polypGastrointestinal disorders2/1541/154
HypoglycaemiaMetabolism and nutrition disorders2/1540/154
Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)2/1541/154
Gastric cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/1542/154
Most frequent other events
Showing 10 of 18
Most frequent other events
EventCanagliflozin 100mgPlacebo
NasopharyngitisInfections and infestations54/15457/154
HypoglycaemiaMetabolism and nutrition disorders33/15432/154
Blood glucose decreasedInvestigations27/15423/154
Back painMusculoskeletal and connective tissue disorders15/15417/154
ConstipationGastrointestinal disorders15/15410/154
Type 2 diabetes mellitusMetabolism and nutrition disorders5/15414/154
Diabetic retinopathyEye disorders9/15410/154
DiarrhoeaGastrointestinal disorders7/15410/154
BronchitisInfections and infestations8/15410/154
InfluenzaInfections and infestations9/15410/154

Baseline characteristics

Age, Continuous
Age, Continuous(years)Canagliflozin 100mgPlaceboTotal
Mean62.5 ± 10.562.4 ± 11.162.5 ± 10.7
Sex: Female, Male
Sex: Female, Male(Participants)Canagliflozin 100mgPlaceboTotal
Female392564
Male115129244
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Canagliflozin 100mgPlaceboTotal
Asian(Japanese)154154308
07

Study locations

26 sites
  • Research site
    Aichi, Japan
  • Research site
    Chiba, Japan
  • Research site
    Fukuoka, Japan
  • Research site
    Fukushima, Japan
  • Research site
    Gunma, Japan
  • Research site
    Hiroshima, Japan
  • Research site
    Hokkaido, Japan
  • Research site
    Hyōgo, Japan
  • Research site
    Ibaraki, Japan
  • Research site
    Kagawa, Japan
  • Research site
    Kagoshima, Japan
  • Research site
    Kanagawa, Japan
  • Research site
    Kumamoto, Japan
  • Research site
    Mie, Japan
  • Research site
    Nagano, Japan
  • Research site
    Nagasaki, Japan
  • Research site
    Okinawa, Japan
  • Research site
    Osaka, Japan
  • Research site
    Ōita, Japan
  • Research site
    Saitama, Japan
  • Research site
    Shizuoka, Japan
  • Research site
    Tochigi, Japan
  • Research site
    Tokyo, Japan
  • Research site
    Wakayama, Japan
  • Research site
    Yamagata, Japan
  • Research site
    Yamaguchi, Japan
08

References and documents

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 ↗

Study documents

  • Study protocol · Apr 17, 2020
  • Statistical analysis plan · Feb 16, 2021

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03436693
Lead sponsor
Tanabe Pharma Corporation
Responsible party
Sponsor
First posted
Feb 19, 2018
Start date
Feb 15, 2018
Primary completion
Jan 21, 2021
Completion
Jan 21, 2021
Results posted
Jul 15, 2024
Last update
Jan 7, 2026

Study contacts

General Manager
study director · Tanabe Pharma Corporation

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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