Phase 3 N=308 Randomized Quadruple-blind Treatment

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

Diabetic Nephropathy

Bottom Line

View on ClinicalTrials.gov: NCT03436693 ↗

Enrolled (actual)

308

Serious AEs

24.7%

Results posted

Jul 2024

Primary outcome: Primary: Percentage of Participants With 30% Decline in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Week 104 — 18.2; 29.5 Percentage of Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Canagliflozin (Drug); Placebo (Drug)
Age: Adult, Older Adult · 30+ yrs
Sex: All
Sponsor: Tanabe Pharma Corporation
Primary completion: Jan 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With 30% Decline in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Week 104	18.2; 29.5	—
SECONDARY Percentage of Participants With 40% Decline in eGFR From Baseline at Week 104	10.1; 13.9	—
SECONDARY Change From Baseline in eGFR at Week 104	-10.39; -11.49	0.351
SECONDARY Composite Endpoint of End-stage Renal Disease (ESRD), Doubling of Serum Creatinine, Renal Death, and Cardiovascular (CV) Death	24.29; 38.66	0.293
SECONDARY Change From Baseline in Percentage of Urine Albumin-to -Creatinine Ratio (UACR) at Week 104	0.612; 1.178	<0.001 sig

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 5.5 mmoL/L
Stable blood pressure (diastolic blood pressure (DBP) ≥100mmHg or systolic blood pressure (SBP) ≥180mmHg)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03436693). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.