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

Diabetic Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03436693
• Other study ID #: TA-7284-14
• Status: Completed
• Phase: Phase 3
• Start date: February 15, 2018
• Est. completion date: January 21, 2021

Study information

• Verified date: September 2021
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: January 21, 2021
• Est. primary completion date: January 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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) =180mmHg or systolic blood pressure (SBP) =100mmHg)

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases

Intervention

Drug:
• Canagliflozin
Canagliflozin 100mg orally once daily
• Placebo
Placebo orally once daily

Locations

Country	Name	City	State
Japan	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	Hyogo
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	Oita
Japan	Research site	Okinawa
Japan	Research site	Osaka
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

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of subjects with a decline in estimated glomerular filtration rate (eGFR) from baseline at Week 104		Baseline and Week 104
Secondary	Change from baseline in eGFR at each assessment time point		Baseline to Week 104
Secondary	Time to the first occurrence of an event in the composite endpoint: end-stage renal disease (ESRD), doubling of serum creatinine, renal death, or cardiovascular (CV) death		up to approximately 104 weeks
Secondary	Change from baseline in urine albumin-to-creatinine ratio (UACR) at each assessment time point		Baseline to Week 104