Trial Outcomes & Findings for Efficacy and Safety of Canagliflozin (TA-7284) in Patients With Diabetic Nephropathy (NCT NCT03436693)
NCT ID: NCT03436693
Last Updated: 2026-01-07
Results Overview
Percentage of participants with 30% decline in eGFR was calculated by multiple imputation method for missing data.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
308 participants
Primary outcome timeframe
Week 104
Results posted on
2026-01-07
Participant Flow
Participant milestones
| Measure |
Canagliflozin 100mg
Canagliflozin 100mg orally once daily for 104 Weeks
|
Placebo
Placebo orally once daily for 104 Weeks
|
|---|---|---|
|
Overall Study
STARTED
|
154
|
154
|
|
Overall Study
COMPLETED
|
124
|
127
|
|
Overall Study
NOT COMPLETED
|
30
|
27
|
Reasons for withdrawal
| Measure |
Canagliflozin 100mg
Canagliflozin 100mg orally once daily for 104 Weeks
|
Placebo
Placebo orally once daily for 104 Weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
22
|
10
|
|
Overall Study
Physician Decision
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
13
|
|
Overall Study
Progressive Disease
|
1
|
1
|
Baseline Characteristics
Efficacy and Safety of Canagliflozin (TA-7284) in Patients With Diabetic Nephropathy
Baseline characteristics by cohort
| Measure |
Canagliflozin 100mg
n=154 Participants
Canagliflozin 100mg orally once daily for 104 Weeks
|
Placebo
n=154 Participants
Placebo orally once daily for 104 Weeks
|
Total
n=308 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 10.5 • n=37 Participants
|
62.4 years
STANDARD_DEVIATION 11.1 • n=56 Participants
|
62.5 years
STANDARD_DEVIATION 10.7 • n=95 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=37 Participants
|
25 Participants
n=56 Participants
|
64 Participants
n=95 Participants
|
|
Sex: Female, Male
Male
|
115 Participants
n=37 Participants
|
129 Participants
n=56 Participants
|
244 Participants
n=95 Participants
|
|
Race/Ethnicity, Customized
Asian(Japanese)
|
154 Participants
n=37 Participants
|
154 Participants
n=56 Participants
|
308 Participants
n=95 Participants
|
PRIMARY outcome
Timeframe: Week 104Population: Full Analysis Set. All Patients were analyzed according to their randomized treatment assignment.
Percentage of participants with 30% decline in eGFR was calculated by multiple imputation method for missing data.
Outcome measures
| Measure |
Canagliflozin 100mg
n=154 Participants
Canagliflozin 100mg orally once daily for 104 Weeks
|
Placebo
n=154 Participants
Placebo orally once daily for 104 Weeks
|
|---|---|---|
|
Percentage of Participants With 30% Decline in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Week 104
|
18.2 Percentage of Participants
Interval 11.7 to 24.8
|
29.5 Percentage of Participants
Interval 21.9 to 37.2
|
SECONDARY outcome
Timeframe: Week 104Population: Full Analysis Set. All Patients were analyzed according to their randomized treatment assignment.
Percentage of participants with 40% decline in eGFR was calculated by multiple imputation method for missing data.
Outcome measures
| Measure |
Canagliflozin 100mg
n=154 Participants
Canagliflozin 100mg orally once daily for 104 Weeks
|
Placebo
n=154 Participants
Placebo orally once daily for 104 Weeks
|
|---|---|---|
|
Percentage of Participants With 40% Decline in eGFR From Baseline at Week 104
|
10.1 percentage of Participants
Interval 5.0 to 15.3
|
13.9 percentage of Participants
Interval 8.0 to 19.9
|
SECONDARY outcome
Timeframe: Baseline and Week 104Population: For Canagliflozin 100mg, Outcome measure for 30 patients was not assessed at a certain timepoint due to dropout. For Placebo, Outcome measure for 27 patients was not assessed at a certain timepoint due to dropout.
Outcome measures
| Measure |
Canagliflozin 100mg
n=124 Participants
Canagliflozin 100mg orally once daily for 104 Weeks
|
Placebo
n=127 Participants
Placebo orally once daily for 104 Weeks
|
|---|---|---|
|
Change From Baseline in eGFR at Week 104
|
-10.39 mL/min/1.73m^2
Standard Error 0.83
|
-11.49 mL/min/1.73m^2
Standard Error 0.83
|
SECONDARY outcome
Timeframe: up to approximately 108 weeksPopulation: Full Analysis Set. All Patients were analyzed according to their randomized treatment assignment.
Outcome measures
| Measure |
Canagliflozin 100mg
n=154 Participants
Canagliflozin 100mg orally once daily for 104 Weeks
|
Placebo
n=154 Participants
Placebo orally once daily for 104 Weeks
|
|---|---|---|
|
Composite Endpoint of End-stage Renal Disease (ESRD), Doubling of Serum Creatinine, Renal Death, and Cardiovascular (CV) Death
|
24.29 Event rate per 1000 patient-years
|
38.66 Event rate per 1000 patient-years
|
SECONDARY outcome
Timeframe: Baseline and Week 104Population: Canagliflozin 100mg: Outcome measure for 30 patients was not assessed at a certain timepoint due to dropout. Placebo: Outcome measure for 27 patients was not assessed at a certain timepoint due to dropout.
Outcome measures
| Measure |
Canagliflozin 100mg
n=124 Participants
Canagliflozin 100mg orally once daily for 104 Weeks
|
Placebo
n=127 Participants
Placebo orally once daily for 104 Weeks
|
|---|---|---|
|
Change From Baseline in Percentage of Urine Albumin-to -Creatinine Ratio (UACR) at Week 104
|
0.612 percent change
Interval 0.525 to 0.714
|
1.178 percent change
Interval 1.01 to 1.373
|
Adverse Events
Canagliflozin 100mg
Serious events: 43 serious events
Other events: 106 other events
Deaths: 4 deaths
Placebo
Serious events: 33 serious events
Other events: 106 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Canagliflozin 100mg
n=154 participants at risk
Canagliflozin 100mg orally once daily for 104 Weeks
|
Placebo
n=154 participants at risk
Placebo orally once daily for 104 Weeks
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.65%
1/154 • up to approximately 108 weeks
|
0.00%
0/154 • up to approximately 108 weeks
|
|
Cardiac disorders
Angina pectoris
|
0.65%
1/154 • up to approximately 108 weeks
|
0.00%
0/154 • up to approximately 108 weeks
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Cardiac disorders
Cardiac failure acute
|
0.65%
1/154 • up to approximately 108 weeks
|
1.3%
2/154 • up to approximately 108 weeks
|
|
Cardiac disorders
Myocardial infarction
|
3.9%
6/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Eye disorders
Cataract
|
5.8%
9/154 • up to approximately 108 weeks
|
1.3%
2/154 • up to approximately 108 weeks
|
|
Eye disorders
Cataract cortical
|
0.65%
1/154 • up to approximately 108 weeks
|
0.00%
0/154 • up to approximately 108 weeks
|
|
Eye disorders
Diabetic retinopathy
|
1.9%
3/154 • up to approximately 108 weeks
|
0.00%
0/154 • up to approximately 108 weeks
|
|
Eye disorders
Glaucoma
|
1.9%
3/154 • up to approximately 108 weeks
|
0.00%
0/154 • up to approximately 108 weeks
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Eye disorders
Vitreous haemorrhage
|
0.65%
1/154 • up to approximately 108 weeks
|
0.00%
0/154 • up to approximately 108 weeks
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Gastrointestinal disorders
Gastric varices haemorrhage
|
0.65%
1/154 • up to approximately 108 weeks
|
0.00%
0/154 • up to approximately 108 weeks
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/154 • up to approximately 108 weeks
|
1.3%
2/154 • up to approximately 108 weeks
|
|
Gastrointestinal disorders
Large intestine polyp
|
1.3%
2/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Gastrointestinal disorders
Pancreatic fistula
|
0.00%
0/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Gastrointestinal disorders
Pancreatitis
|
0.65%
1/154 • up to approximately 108 weeks
|
0.00%
0/154 • up to approximately 108 weeks
|
|
General disorders
Death
|
0.65%
1/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
General disorders
Gait disturbance
|
0.65%
1/154 • up to approximately 108 weeks
|
0.00%
0/154 • up to approximately 108 weeks
|
|
Hepatobiliary disorders
Cholangitis sclerosing
|
0.65%
1/154 • up to approximately 108 weeks
|
0.00%
0/154 • up to approximately 108 weeks
|
|
Infections and infestations
Cellulitis
|
0.65%
1/154 • up to approximately 108 weeks
|
0.00%
0/154 • up to approximately 108 weeks
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Infections and infestations
Influenza
|
0.65%
1/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Infections and infestations
Pneumonia
|
0.65%
1/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Infections and infestations
Pyelonephritis
|
0.65%
1/154 • up to approximately 108 weeks
|
0.00%
0/154 • up to approximately 108 weeks
|
|
Infections and infestations
Pyelonephritis acute
|
0.65%
1/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Infections and infestations
Septic shock
|
0.00%
0/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Injury, poisoning and procedural complications
Failure to anastomose
|
0.00%
0/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.65%
1/154 • up to approximately 108 weeks
|
0.00%
0/154 • up to approximately 108 weeks
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.65%
1/154 • up to approximately 108 weeks
|
0.00%
0/154 • up to approximately 108 weeks
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Injury, poisoning and procedural complications
Spinal cord injury
|
0.00%
0/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.3%
2/154 • up to approximately 108 weeks
|
0.00%
0/154 • up to approximately 108 weeks
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.65%
1/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.65%
1/154 • up to approximately 108 weeks
|
0.00%
0/154 • up to approximately 108 weeks
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.65%
1/154 • up to approximately 108 weeks
|
0.00%
0/154 • up to approximately 108 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
1.3%
2/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/154 • up to approximately 108 weeks
|
1.3%
2/154 • up to approximately 108 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrooesophageal cancer
|
0.00%
0/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.65%
1/154 • up to approximately 108 weeks
|
0.00%
0/154 • up to approximately 108 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.65%
1/154 • up to approximately 108 weeks
|
0.00%
0/154 • up to approximately 108 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.65%
1/154 • up to approximately 108 weeks
|
0.00%
0/154 • up to approximately 108 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.00%
0/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.65%
1/154 • up to approximately 108 weeks
|
0.00%
0/154 • up to approximately 108 weeks
|
|
Nervous system disorders
Brain stem infarction
|
0.00%
0/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Nervous system disorders
Facial paralysis
|
0.65%
1/154 • up to approximately 108 weeks
|
0.00%
0/154 • up to approximately 108 weeks
|
|
Nervous system disorders
Myelopathy
|
0.65%
1/154 • up to approximately 108 weeks
|
0.00%
0/154 • up to approximately 108 weeks
|
|
Nervous system disorders
Seizure
|
0.65%
1/154 • up to approximately 108 weeks
|
0.00%
0/154 • up to approximately 108 weeks
|
|
Nervous system disorders
Thalamus haemorrhage
|
0.65%
1/154 • up to approximately 108 weeks
|
0.00%
0/154 • up to approximately 108 weeks
|
|
Psychiatric disorders
Completed suicide
|
0.65%
1/154 • up to approximately 108 weeks
|
0.00%
0/154 • up to approximately 108 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
0.65%
1/154 • up to approximately 108 weeks
|
0.00%
0/154 • up to approximately 108 weeks
|
|
Renal and urinary disorders
Bladder mass
|
0.00%
0/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/154 • up to approximately 108 weeks
|
1.3%
2/154 • up to approximately 108 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/154 • up to approximately 108 weeks
|
1.3%
2/154 • up to approximately 108 weeks
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/154 • up to approximately 108 weeks
|
0.65%
1/154 • up to approximately 108 weeks
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.65%
1/154 • up to approximately 108 weeks
|
0.00%
0/154 • up to approximately 108 weeks
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.65%
1/154 • up to approximately 108 weeks
|
0.00%
0/154 • up to approximately 108 weeks
|
Other adverse events
| Measure |
Canagliflozin 100mg
n=154 participants at risk
Canagliflozin 100mg orally once daily for 104 Weeks
|
Placebo
n=154 participants at risk
Placebo orally once daily for 104 Weeks
|
|---|---|---|
|
Eye disorders
Diabetic retinopathy
|
5.8%
9/154 • up to approximately 108 weeks
|
6.5%
10/154 • up to approximately 108 weeks
|
|
Gastrointestinal disorders
Constipation
|
9.7%
15/154 • up to approximately 108 weeks
|
6.5%
10/154 • up to approximately 108 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
4.5%
7/154 • up to approximately 108 weeks
|
6.5%
10/154 • up to approximately 108 weeks
|
|
General disorders
Oedema peripheral
|
0.65%
1/154 • up to approximately 108 weeks
|
5.8%
9/154 • up to approximately 108 weeks
|
|
Infections and infestations
Bronchitis
|
5.2%
8/154 • up to approximately 108 weeks
|
6.5%
10/154 • up to approximately 108 weeks
|
|
Infections and infestations
Influenza
|
5.8%
9/154 • up to approximately 108 weeks
|
6.5%
10/154 • up to approximately 108 weeks
|
|
Infections and infestations
Nasopharyngitis
|
35.1%
54/154 • up to approximately 108 weeks
|
37.0%
57/154 • up to approximately 108 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
6.5%
10/154 • up to approximately 108 weeks
|
5.8%
9/154 • up to approximately 108 weeks
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
1.9%
3/154 • up to approximately 108 weeks
|
5.2%
8/154 • up to approximately 108 weeks
|
|
Investigations
Blood glucose decreased
|
17.5%
27/154 • up to approximately 108 weeks
|
14.9%
23/154 • up to approximately 108 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.9%
3/154 • up to approximately 108 weeks
|
5.8%
9/154 • up to approximately 108 weeks
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
5.2%
8/154 • up to approximately 108 weeks
|
1.3%
2/154 • up to approximately 108 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
21.4%
33/154 • up to approximately 108 weeks
|
20.8%
32/154 • up to approximately 108 weeks
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
3.2%
5/154 • up to approximately 108 weeks
|
9.1%
14/154 • up to approximately 108 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.7%
15/154 • up to approximately 108 weeks
|
11.0%
17/154 • up to approximately 108 weeks
|
|
Renal and urinary disorders
Diabetic nephropathy
|
3.2%
5/154 • up to approximately 108 weeks
|
5.2%
8/154 • up to approximately 108 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.2%
8/154 • up to approximately 108 weeks
|
3.9%
6/154 • up to approximately 108 weeks
|
|
Vascular disorders
Hypertension
|
5.8%
9/154 • up to approximately 108 weeks
|
5.2%
8/154 • up to approximately 108 weeks
|
Additional Information
Clinical Trials, Information Desk
Tanabe Pharma Corporation
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER