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

Phase 3

Completed

• Conditions: Diabetic Nephropathy
• Interventions: Drug: Canagliflozin; Drug: Placebo

• Registration Number: NCT03436693
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-01
• Study First Submitted QC: 2018-02-12
• Study Start: 2018-02-15
• Study First Posted: 2018-02-19
• Primary Completion: 2021-01-21
• Study Completion: 2021-01-21
• Results First Submitted: 2023-03-30
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-28
• Last Update Submitted: 2024-01-28
• Results First Posted: 2024-07-15
• Last Update Posted: 2024-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 308

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

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Canagliflozin 100mg	Canagliflozin	-
Placebo	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research site; 🇯🇵 Yamaguchi, Japan