Clinical trial NCT03436693: Efficacy and Safety of Canagliflozin (TA-7284) in Patients With Diabetic Nephropathy
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Canagliflozin (TA-7284) in Patients With Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Nephropathy
Keywords: Diabetic Nephropathy
Canagliflozin
Canaglu
Diabetes Mellitus, Type 2
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2018-02-19
Enrollment: 308
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of Participants With 30% Decline in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Week 104
timeFrame: Week 104
Secondary outcomes:
measure: Percentage of Participants With 40% Decline in eGFR From Baseline at Week 104
timeFrame: Week 104
measure: Change From Baseline in eGFR at Week 104
timeFrame: Baseline and Week 104
measure: Composite Endpoint of End-stage Renal Disease (ESRD), Doubling of Serum Creatinine, Renal Death, and Cardiovascular (CV) Death
timeFrame: up to approximately 108 weeks
measure: Change From Baseline in Percentage of Urine Albumin-to -Creatinine Ratio (UACR) at Week 104
timeFrame: Baseline and Week 104
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Research site
city: Chiba
country: Japan
facility: Research site
city: Fukuoka
country: Japan
facility: Research site
city: Fukushima
country: Japan
facility: Research site
city: Gunma
country: Japan
facility: Research site
city: Hiroshima
country: Japan
facility: Research site
city: Hokkaido
country: Japan
facility: Research site
city: Hyogo
country: Japan
facility: Research site
city: Ibaraki
country: Japan
facility: Research site
city: Kagawa
country: Japan
facility: Research site
city: Kagoshima
country: Japan
facility: Research site
city: Kanagawa
country: Japan
facility: Research site
city: Kumamoto
country: Japan
facility: Research site
city: Mie
country: Japan
facility: Research site
city: Nagano
country: Japan
facility: Research site
city: Nagasaki
country: Japan
facility: Research site
city: Oita
country: Japan
facility: Research site
city: Okinawa
country: Japan
facility: Research site
city: Osaka
country: Japan
facility: Research site
city: Saitama
country: Japan
facility: Research site
city: Shizuoka
country: Japan
facility: Research site
city: Tochigi
country: Japan
facility: Research site
city: Tokyo
country: Japan
facility: Research site
city: Wakayama
country: Japan
facility: Research site
city: Yamagata
country: Japan
facility: Research site
city: Yamaguchi
country: Japan
facility: Research site
Study officials:
affiliation: Mitsubishi Tanabe Pharma Corporation
name: General Manager
role: STUDY_DIRECTOR
References:
citation: 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.