Phase 3
Completed N=4,401
Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy
Source: ClinicalTrials.gov NCT02065791 ↗Enrolled (actual)
4,401
Serious AEs
35.1%
Results posted
Nov 2019
Primary outcomePrimary: Primary Composite Endpoint of Doubling of Serum Creatinine (DoSC), End-stage Kidney Disease (ESKD), and Renal or Cardiovascular (CV) Death — 61.24; 43.21 Event rate per 1000 participant-years — p=< 0.0001
◆ Published Evidence
Emerging
5citations · ~5 / year
Impact of canagliflozin on heart stress and outcomes: Pooled insights from CREDENCE and CANVAS.
Summary
The goal of this study is to assess whether canagliflozin has a renal and vascular protective effect in reducing the progression of renal impairment relative to placebo in participants with type 2 diabetes mellitus (T2DM), Stage 2 or 3 chronic kidney disease (CKD) and macroalbuminuria, who are receiving standard of care including a maximum tolerated labeled daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB).
Linked Publications (5)
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Impact of canagliflozin on heart stress and outcomes: Pooled insights from CREDENCE and CANVAS.
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Baseline Kidney Function, Albuminuria, and Urine Albumin-Creatinine Ratio Reduction with Finerenone, Empagliflozin, or Both: Post Hoc Analyses of CONFIDENCE Trial.
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Association of Urinary EGF with Kidney Outcomes and Effects of Sodium-Glucose Cotransporter 2 Inhibition.
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Sodium-Glucose Cotransporter 2 Inhibition and Hospitalizations in Patients with CKD: A Meta-Analysis of Kidney Outcome Trials.
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Impact of canagliflozin on the cardiorenal effects of dietary sodium intake in type 2 diabetes: a post hoc analysis of the CREDENCE trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Composite Endpoint of Doubling of Serum Creatinine (DoSC), End-stage Kidney Disease (ESKD), and Renal or Cardiovascular (CV) Death |
61.24; 43.21 | < 0.0001 sig |
| SECONDARY Composite Endpoint of CV Death and Hospitalized Heart Failure (HHF) |
45.44; 31.47 | =0.0001 sig |
| SECONDARY Major Adverse Cardiac Event (MACE) |
48.67; 38.71 | =0.0121 sig |
| SECONDARY Hospitalized Heart Failure (HHF) |
25.33; 15.65 | =0.0003 sig |
| SECONDARY Renal Composite Endpoint |
40.36; 26.99 | <0.0001 sig |
| SECONDARY Cardiovascular (CV) Death |
24.38; 19.01 | =0.0502 |
| SECONDARY All-cause Mortality |
35.00; 29.04 | = 0.0727 |
| SECONDARY CV Composite Endpoint |
66.95; 49.35 | 0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes mellitus with a hemoglobin A1c (HbA1c) greater than or equal to (>=) 6.5 percent (%) and less than or equal to ( = 30 milliliter (mL)/minute (min)/1.73meter (m)^2 and less than ( ) 300 milligram (mg)/gram (g) and 5.5 millimole (mmol)/liter (L) during Screening
Data sourced from ClinicalTrials.gov (NCT02065791) 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.