Efficacy and Safety of Canagliflozin (TA-7284) in Patients With Diabetic Nephropathy (NCT03436693) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Canagliflozin (TA-7284) in Patients With Diabetic Nephropathy
Japan308 participantsStarted 2018-02-15
Plain-language 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
Who can participate
Age range30 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
What they're measuring
1
Percentage of Participants With 30% Decline in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Week 104