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

Conditions

• Diabetes Mellitus, Type 2
• Diabetic Nephropathy

Eligibility Criteria

Sex

ALL

Age

30 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Canagliflozin — DRUG
  One 100 mg over-encapsulated tablet orally once daily
• Placebo — DRUG
  One matching placebo capsule orally (by mouth) once daily

Study Details

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).

Key Dates

Start date

Feb 17, 2014

Status verified

Dec 2019

Primary completion

Oct 30, 2018

Completion

Oct 30, 2018

Study Design

Enrollment

4,401 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Canagliflozin 100 mg
  Each participant will receive 100 mg of canagliflozin once daily
• Placebo Comparator: Placebo
  Each participant will receive matching placebo once daily

Primary Outcome Measure

Primary Composite Endpoint of Doubling of Serum Creatinine (DoSC), End-stage Kidney Disease (ESKD), and Renal or Cardiovascular (CV) Death [ Time Frame: Up to 4.6 years ]

Locations (152)

Find similar trials in Birmingham, AL

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