Phase 3
Completed N=308
Efficacy and Safety of Canagliflozin (TA-7284) in Patients With Diabetic Nephropathy
Source: ClinicalTrials.gov NCT03436693 ↗Enrolled (actual)
308
Serious AEs
24.7%
Results posted
Jul 2024
Primary outcomePrimary: Percentage of Participants With 30% Decline in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Week 104 — 18.2; 29.5 Percentage of Participants
◆ Published Evidence
Established
28citations · ~7 / year
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.
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
Linked Publications (2)
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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.
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Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes.
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 |
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)
Data sourced from ClinicalTrials.gov (NCT03436693) and the linked publication. 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. Informational only — not medical advice.