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

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2, Diabetic Nephropathy

In brief

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 facts

Study ID

NCT02065791

Run by

Janssen Research & Development, LLC

People needed

4401

Starts

2014-02-17

Expected to finish

2018-10-30

Last updated by the study team

2019-12-05

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Montgomery, Alabama, United States
• Study site — Tempe, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Sherwood, Arkansas, United States
• Study site — Bakersfield, California, United States
• Study site — Chula Vista, California, United States
• Study site — Covina, California, United States
• Study site — Downey, California, United States
• Study site — Fountain Valley, California, United States
• Study site — Hawthorne, California, United States
• Study site — Inglewood, California, United States
• Study site — Laguna Hills, California, United States
• Study site — Lakewood, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Lynwood, California, United States
• Study site — Northridge, California, United States
• Study site — Oakland, California, United States
• Study site — Orange, California, United States
• Study site — Pasadena, California, United States
• Study site — Roseville, California, United States
• Study site — Sacramento, California, United States
• Study site — Salinas, California, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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