drugset / Trial / NCT02065791

Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy

NCT02065791 ↗

RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

Start
2014-02-17
Primary completion
2018-10-30
Completion
2018-10-30

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs Canagliflozin 100 mg; p < 0.0001; Hazard Ratio (HR) 0.70 (95% CI 0.59 to 0.82) NCT02065791 ↗

registry NUMBER Placebo: 61.24 Event rate per 1000 participant-years NUMBER Canagliflozin 100 mg: 43.21 Event rate per 1000 participant-years NCT02065791 ↗

release “The renal results from CREDENCE found INVOKANA®demonstrated a 30 percent reduction in the risk of the primary composite endpoint” jnj.com ↗

release “the CREDENCE trial stop early because it met the prespecified criteria for efficacy” jnj.com ↗

release “Phase 3 CREDENCE study, which was stopped early because it met the prespecified criteria for efficacy.” jnj.com ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject CANAGLIFLOZIN ANHYDROUS Small molecule 100 mg Oral