---
title: Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy
nct_id: NCT02065791
overall_status: COMPLETED
phase: PHASE3
sponsor: Janssen Research & Development, LLC
study_type: INTERVENTIONAL
primary_condition: Diabetes Mellitus, Type 2
countries: United States, Argentina, Australia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, France, Germany, Guatemala, Hungary, India, Japan, Lithuania, Malaysia, Mexico, New Zealand, Philippines, Poland, Puerto Rico, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Taiwan, Ukraine, United Arab Emirates, United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02065791.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02065791"
ct_last_update_post_date: 2019-12-05
last_seen_at: "2026-05-12T06:52:03.127Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy

**Official Title:** A Randomized, Double-blind, Event-driven, Placebo-controlled, Multicenter Study of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Subjects With Type 2 Diabetes Mellitus and Diabetic Nephropathy

**NCT ID:** [NCT02065791](https://clinicaltrials.gov/study/NCT02065791)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 4401
- **Lead Sponsor:** Janssen Research & Development, LLC
- **Collaborators:** The George Institute for Global Health, Australia
- **Conditions:** Diabetes Mellitus, Type 2, Diabetic Nephropathy
- **Start Date:** 2014-02-17
- **Completion Date:** 2018-10-30
- **CT.gov Last Update:** 2019-12-05

## Brief 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).

## Detailed Description

This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect), parallel-group, multicenter study of the effects of canagliflozin on renal and cardiovascular outcomes in participants with type 2 diabetes mellitus (T2DM) and diabetic nephropathy, who are receiving standard of care including a maximum tolerated daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB).

The study will consist of a pretreatment phase (several weeks), and a double-blind treatment phase (up to approximately 66 months). During the pretreatment phase all participants will also receive diet/exercise counseling for lipid and blood pressure management as well as counseling on renal and cardiovascular (CV) risk factor medication. A post-treatment follow-up contact or visit will take place approximately 30 days after the last dose of study drug or the completion of the study. The total duration of the study is estimated to be about 5 to 5.5 years. Approximately 4,200 participants will be randomized in a 1:1 ratio to canagliflozin or matching placebo. Participants randomized to canagliflozin will receive a dose of 100 mg once daily. The overall safety and tolerability of canagliflozin will be evaluated by collecting information on adverse events, laboratory tests, vital signs (pulse, blood pressure), physical examination, and body weight.

## Eligibility

- **Minimum age:** 30 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Canagliflozin 100 mg** (EXPERIMENTAL) — Each participant will receive 100 mg of canagliflozin once daily
- **Placebo** (PLACEBO_COMPARATOR) — Each participant will receive matching placebo once daily

## Interventions

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

## Primary Outcomes

- **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)_ — Primary composite endpoint is the composite of DoSC, ESKD, and renal or CV death. DoSC: from baseline average determination (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). ESKD: as initiation of maintenance dialysis for at least 30 days, or renal transplantation, or an estimated glomerular filtration rate (eGFR) value of less than (\<)15 milliliters per minute per 1.73 square meter (mL/min/1.73 m\^2) (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). Renal death: death in participants who had reached ESKD, died without initiating renal replacement therapy, and no other cause of death was determined via adjudication. Adjudication of these events by Endpoint Adjudication Committee (EAC) was performed in blinded fashion. Event rate estimated based on time to first occurrence of primary composite endpoint are presented.

## Secondary Outcomes

- **Composite Endpoint of CV Death and Hospitalized Heart Failure (HHF)** _(time frame: Up to 4.6 years)_
- **Major Adverse Cardiac Event (MACE)** _(time frame: Up to 4.6 years)_
- **Hospitalized Heart Failure (HHF)** _(time frame: Up to 4.6 years)_
- **Renal Composite Endpoint** _(time frame: Up to 4.6 years)_
- **Cardiovascular (CV) Death** _(time frame: Up to 4.6 years)_
- **All-cause Mortality** _(time frame: Up to 4.6 years)_
- **CV Composite Endpoint** _(time frame: Up to 4.6 years)_

## Locations (575)

- Birmingham, Alabama, United States
- Montgomery, Alabama, United States
- Tempe, Arizona, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Sherwood, Arkansas, United States
- Bakersfield, California, United States
- Chula Vista, California, United States
- Covina, California, United States
- Downey, California, United States
- Fountain Valley, California, United States
- Hawthorne, California, United States
- Inglewood, California, United States
- Laguna Hills, California, United States
- Lakewood, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Lynwood, California, United States
- Northridge, California, United States
- Oakland, California, United States
- Orange, California, United States
- Pasadena, California, United States
- Roseville, California, United States
- Sacramento, California, United States
- Salinas, California, United States
- San Diego, California, United States
- San Dimas, California, United States
- Stanford, California, United States
- Tustin, California, United States
- Whittier, California, United States
- Denver, Colorado, United States
- Golden, Colorado, United States
- Lakewood, Colorado, United States
- Washington, Colorado, United States
- Washington D.C., District of Columbia, United States
- Coral Springs, Florida, United States
- Doral, Florida, United States
- Hialeah, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Miami Springs, Florida, United States
- North Miami Beach, Florida, United States
- Ocala, Florida, United States
- Port Charlotte, Florida, United States
- St. Petersburg, Florida, United States
- Winter Park, Florida, United States
- Atlanta, Georgia, United States
- Augusta, Georgia, United States
- Columbus, Georgia, United States
- Roswell, Georgia, United States
- Snellville, Georgia, United States
- Stockbridge, Georgia, United States
- Chicago, Illinois, United States
- Crystal Lake, Illinois, United States
- Gurnee, Illinois, United States
- Mount Prospect, Illinois, United States
- Winfield, Illinois, United States
- Fort Wayne, Indiana, United States
- Indianapolis, Indiana, United States
- Merrillville, Indiana, United States
- Michigan City, Indiana, United States
- Muncie, Indiana, United States
- Council Bluffs, Iowa, United States
- Louisville, Kentucky, United States
- Paducah, Kentucky, United States
- Kenner, Louisiana, United States
- Rockport, Maine, United States
- Scarborough, Maine, United States
- Annapolis, Maryland, United States
- Baltimore, Maryland, United States
- Beltsville, Maryland, United States
- Hyattsville, Maryland, United States
- Silver Spring, Maryland, United States
- Boston, Massachusetts, United States
- Plymouth, Massachusetts, United States
- Springfield, Massachusetts, United States
- Worcester, Massachusetts, United States
- Flint, Michigan, United States
- Jackson, Mississippi, United States
- Chesterfield, Missouri, United States
- Kansas City, Missouri, United States
- St Louis, Missouri, United States
- Fremont, Nebraska, United States
- Lincoln, Nebraska, United States
- Omaha, Nebraska, United States
- Reno, Nebraska, United States
- Las Vegas, Nevada, United States
- Eatontown, New Jersey, United States
- Albuquerque, New Mexico, United States
- Albany, New York, United States
- Binghamton, New York, United States
- Buffalo, New York, United States
- Great Neck, New York, United States
- Lake Success, New York, United States
- New Hyde Park, New York, United States
- New York, New York, United States
- Ridgewood, New York, United States
- Riverhead, New York, United States
- Smithtown, New York, United States
- Springfield Gardens, New York, United States
- Asheville, North Carolina, United States
- Calabash, North Carolina, United States
- Charlotte, North Carolina, United States
- Durham, North Carolina, United States
- Greensboro, North Carolina, United States
- Greenville, North Carolina, United States
- High Point, North Carolina, United States
- Morehead City, North Carolina, United States
- Morganton, North Carolina, United States
- Raleigh, North Carolina, United States
- Tabor City, North Carolina, United States
- Whiteville, North Carolina, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Maumee, Ohio, United States
- Roseburg, Oregon, United States
- Beaver, Pennsylvania, United States
- Bethlehem, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Anderson, South Carolina, United States
- Columbia, South Carolina, United States
- Lancaster, South Carolina, United States
- Murrells Inlet, South Carolina, United States
- Orangeburg, South Carolina, United States
- Sumter, South Carolina, United States
- Chattanooga, Tennessee, United States
- Knoxville, Tennessee, United States
- Memphis, Tennessee, United States
- Arlington, Texas, United States
- Corpus Christi, Texas, United States
- Corsicana, Texas, United States
- Dallas, Texas, United States
- Edinburg, Texas, United States
- Fort Worth, Texas, United States
- Houston, Texas, United States
- Mesquite, Texas, United States
- San Antonio, Texas, United States
- Schertz, Texas, United States
- Sugar Land, Texas, United States
- Temple, Texas, United States
- Waco, Texas, United States
- Salt Lake City, Utah, United States
- Bennington, Vermont, United States
- Burlington, Vermont, United States
- Bluefield, Virginia, United States
- Mechanicsville, Virginia, United States
- Norfolk, Virginia, United States
- Suffolk, Virginia, United States
- Spokane, Washington, United States
- Huntington, West Virginia, United States
- Milwaukee, Wisconsin, United States
- Bahía Blanca, Argentina
- Buenos Aires, Argentina
- Ciudad Autonoma Buenos Aires, Argentina
- Corrientes, Argentina
- Córdoba, Argentina
- Godoy Cruz, Argentina
- Junín, Argentina
- La Plata, Argentina
- La Plata Lpl Lpl, Argentina
- Mar del Plata, Argentina
- Mendoza, Argentina
- Morón, Argentina
- Munro, Argentina
- Paraná, Argentina
- Quilmes, Argentina
- Ramos Mejía, Argentina
- Rosario, Argentina
- Salta, Argentina
- San Luis, Argentina
- San Martin, Argentina
- San Migeul de Tucuman, Argentina
- San Miguel de Tucumán, Argentina
- San Nicolás, Argentina
- Santa Fe, Argentina
- Sarandí, Argentina
- Tapiales, Argentina
- Temperley, Argentina
- Villa María, Argentina
- Zarate, Buenos Aires, Argentina
- Cairns, Australia
- Concord, Australia
- Darlinghurst, Australia
- Elizabeth Vale, Australia
- Fremantle, Australia
- Gosford, Australia
- Heidelberg, Australia
- Keswick, Australia
- Meadowbrook, Australia
- Parkville, Australia
- Reservoir, Australia
- Richmond, Australia
- St Albans, Australia
- St Leonards, Australia
- Sydney, Australia
- Woolloongabba, Australia
- Aparecida de Goiânia, Brazil
- Belém, Brazil
- Belo Horizonte, Brazil
- _and 375 more_

## Recent Field Changes (last 30 days)

- `locations.|wolverhampton||united kingdom` — added _(2026-05-12)_
- `locations.|wokingham||united kingdom` — added _(2026-05-12)_
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- `locations.|moscow||russia` — added _(2026-05-12)_
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- `locations.|sestroretsk, saint-petersburg||russia` — added _(2026-05-12)_
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- `locations.|volgograd||russia` — added _(2026-05-12)_
- `locations.|yaroslavl||russia` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02065791.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02065791*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*