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

• Status: Completed
• Trial end date: 2018-10-30
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Collaborator: The George Institute for Global Health, Australia
• Treatments: Canagliflozin

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 (<=) 12.0%, with an estimated glomerular filtration rate (eGFR) of >= 30 milliliter (mL)/minute (min)/1.73meter (m)^2 and less than (<) 90 mL/min/1.73 m^2

• Participants need to be on a stable maximum tolerated labeled daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) for at least 4 weeks prior to randomization

• Must have a urine albumin to creatinine ratio (UACR) of greater than (>) 300 milligram (mg)/gram (g) and <= 5000 mg/g

Exclusion Criteria:

• History of diabetic ketoacidosis or type 1 diabetes mellitus

• History of hereditary glucose-galactose malabsorption or primary renal glucosuria

• Renal disease that required treatment with immunosuppressive therapy

• Known significant liver disease

• Current or history of New York Heart Association (NYHA) Class IV heart failure

• Blood potassium level >5.5 millimole (mmol)/liter (L) during Screening