AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 3CREDENCENCT02065791

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

A Phase 3 study testing Canagliflozin in people with Diabetes Mellitus, Type 2 and Diabetic Nephropathy, run by Janssen Research & Development, LLC at 575 sites in 34 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 30 years and older
What is being tested?
Canagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4,401 participants
Where
575 sitesin 34 countries
Study dates
17 Feb 2014to 30 Oct 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

575 sites in 34 countries.

575 sites in 34 countries

United States152 sites

  • Study site

    Albany, New York

  • Study site

    Albuquerque, New Mexico

  • Study site

    Anderson, South Carolina

  • Study site

    Annapolis, Maryland

  • Study site

    Arlington, Texas

  • Study site

    Asheville, North Carolina

  • Study site

    Atlanta, Georgia

  • Study site

    Augusta, Georgia

  • Study site

    Bakersfield, California

  • Study site

    Baltimore, Maryland

  • Study site

    Beaver, Pennsylvania

  • Study site

    Beltsville, Maryland

  • Study site

    Bennington, Vermont

  • Study site

    Bethlehem, Pennsylvania

  • Study site

    Binghamton, New York

  • Study site

    Birmingham, Alabama

  • Study site

    Bluefield, Virginia

  • Study site

    Boston, Massachusetts

  • Study site

    Buffalo, New York

  • Study site

    Burlington, Vermont

  • Study site

    Calabash, North Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Chattanooga, Tennessee

  • Study site

    Chesterfield, Missouri

  • Study site

    Chicago, Illinois

  • Study site

    Chula Vista, California

  • Study site

    Cincinnati, Ohio

  • Study site

    Columbia, South Carolina

  • Study site

    Columbus, Georgia

  • Study site

    Columbus, Ohio

  • Study site

    Coral Springs, Florida

  • Study site

    Corpus Christi, Texas

  • Study site

    Corsicana, Texas

  • Study site

    Council Bluffs, Iowa

  • Study site

    Covina, California

  • Study site

    Crystal Lake, Illinois

  • Study site

    Dallas, Texas

  • Study site

    Denver, Colorado

  • Study site

    Doral, Florida

  • Study site

    Downey, California

  • Study site

    Durham, North Carolina

  • Study site

    Eatontown, New Jersey

  • Study site

    Edinburg, Texas

  • Study site

    Flint, Michigan

  • Study site

    Fort Wayne, Indiana

  • Study site

    Fort Worth, Texas

  • Study site

    Fountain Valley, California

  • Study site

    Fremont, Nebraska

  • Study site

    Golden, Colorado

  • Study site

    Great Neck, New York

  • Study site

    Greensboro, North Carolina

  • Study site

    Greenville, North Carolina

  • Study site

    Gurnee, Illinois

  • Study site

    Hawthorne, California

  • Study site

    Hialeah, Florida

  • Study site

    High Point, North Carolina

  • Study site

    Houston, Texas

  • Study site

    Huntington, West Virginia

  • Study site

    Hyattsville, Maryland

  • Study site

    Indianapolis, Indiana

  • Study site

    Inglewood, California

  • Study site

    Jackson, Mississippi

  • Study site

    Jacksonville, Florida

  • Study site

    Kansas City, Missouri

  • Study site

    Kenner, Louisiana

  • Study site

    Knoxville, Tennessee

  • Study site

    Laguna Hills, California

  • Study site

    Lake Success, New York

  • Study site

    Lakewood, California

  • Study site

    Lakewood, Colorado

  • Study site

    Lancaster, South Carolina

  • Study site

    Las Vegas, Nevada

  • Study site

    Lincoln, Nebraska

  • Study site

    Little Rock, Arkansas

  • Study site

    Long Beach, California

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Lynwood, California

  • Study site

    Maumee, Ohio

  • Study site

    Mechanicsville, Virginia

  • Study site

    Memphis, Tennessee

  • Study site

    Merrillville, Indiana

  • Study site

    Mesquite, Texas

  • Study site

    Miami, Florida

  • Study site

    Miami Springs, Florida

  • Study site

    Michigan City, Indiana

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Montgomery, Alabama

  • Study site

    Morehead City, North Carolina

  • Study site

    Morganton, North Carolina

  • Study site

    Mount Prospect, Illinois

  • Study site

    Muncie, Indiana

  • Study site

    Murrells Inlet, South Carolina

  • Study site

    New Hyde Park, New York

  • Study site

    New York, New York

  • Study site

    Norfolk, Virginia

  • Study site

    North Miami Beach, Florida

  • Study site

    Northridge, California

  • Study site

    Oakland, California

  • Study site

    Ocala, Florida

  • Study site

    Omaha, Nebraska

  • Study site

    Orange, California

  • Study site

    Orangeburg, South Carolina

  • Study site

    Paducah, Kentucky

  • Study site

    Pasadena, California

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Plymouth, Massachusetts

  • Study site

    Port Charlotte, Florida

  • Study site

    Raleigh, North Carolina

  • Study site

    Reno, Nebraska

  • Study site

    Ridgewood, New York

  • Study site

    Riverhead, New York

  • Study site

    Rockport, Maine

  • Study site

    Roseburg, Oregon

  • Study site

    Roseville, California

  • Study site

    Roswell, Georgia

  • Study site

    Sacramento, California

  • Study site

    Salinas, California

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    San Dimas, California

  • Study site

    Scarborough, Maine

  • Study site

    Schertz, Texas

  • Study site

    Sherwood, Arkansas

  • Study site

    Silver Spring, Maryland

  • Study site

    Smithtown, New York

  • Study site

    Snellville, Georgia

  • Study site

    Spokane, Washington

  • Study site

    Springfield, Massachusetts

  • Study site

    Springfield Gardens, New York

  • Study site

    St Louis, Missouri

  • Study site

    St. Petersburg, Florida

  • Study site

    Stanford, California

  • Study site

    Stockbridge, Georgia

  • Study site

    Suffolk, Virginia

  • Study site

    Sugar Land, Texas

  • Study site

    Sumter, South Carolina

  • Study site

    Tabor City, North Carolina

  • Study site

    Tempe, Arizona

  • Study site

    Temple, Texas

  • Study site

    Tucson, Arizona

  • Study site

    Tustin, California

  • Study site

    Waco, Texas

  • Study site

    Washington, Colorado

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Whiteville, North Carolina

  • Study site

    Whittier, California

  • Study site

    Winfield, Illinois

  • Study site

    Winter Park, Florida

  • Study site

    Worcester, Massachusetts

Other trials in United States

United Kingdom38 sites

  • Study site

    Aberdeen

  • Study site

    Antrim

  • Study site

    Barry

  • Study site

    Birmingham

  • Study site

    Blackburn

  • Study site

    Bolton

  • Study site

    Bournemouth

  • Study site

    Bradford

  • Study site

    Bristol

  • Study site

    Burbage

  • Study site

    Cardff

  • Study site

    Cardiff

  • Study site

    Carlshalton

  • Study site

    Carmarthen

  • Study site

    Chester

  • Study site

    Darlington

  • Study site

    Doncaster

  • Study site

    Durham

  • Study site

    Ely

  • Study site

    Hampstead

  • Study site

    Harlow

  • Study site

    Huntingdon

  • Study site

    Liskeard

  • Study site

    London

  • Study site

    Middlesbrough

  • Study site

    Plymouth

  • Study site

    Rhyl

  • Study site

    Royal Leamington Spa

  • Study site

    Rugby

  • Study site

    Salford

  • Study site

    Stoke-on-Trent

  • Study site

    Swansea

  • Study site

    Torpoint

  • Study site

    Watford

  • Study site

    Welwyn Garden City

  • Study site

    Westcliff-on-Sea

  • Study site

    Wokingham

  • Study site

    Wolverhampton

Other trials in United Kingdom

Argentina29 sites

  • Study site

    Bahía Blanca

  • Study site

    Buenos Aires

  • Study site

    Ciudad Autonoma Buenos Aires

  • Study site

    Córdoba

  • Study site

    Corrientes

  • Study site

    Godoy Cruz

  • Study site

    Junín

  • Study site

    La Plata

  • Study site

    La Plata Lpl Lpl

  • Study site

    Mar del Plata

  • Study site

    Mendoza

  • Study site

    Morón

  • Study site

    Munro

  • Study site

    Paraná

  • Study site

    Quilmes

  • Study site

    Ramos Mejía

  • Study site

    Rosario

  • Study site

    Salta

  • Study site

    San Luis

  • Study site

    San Martin

  • Study site

    San Migeul de Tucuman

  • Study site

    San Miguel de Tucumán

  • Study site

    San Nicolás

  • Study site

    Santa Fe

  • Study site

    Sarandí

  • Study site

    Tapiales

  • Study site

    Temperley

  • Study site

    Villa María

  • Study site

    Zarate, Buenos Aires

Other trials in Argentina

Japan26 sites

  • Study site

    Ageo-shi

  • Study site

    Chiyoda-ku

  • Study site

    Fukuoka

  • Study site

    Hamamatsu

  • Study site

    Hamura-shi

  • Study site

    Ina-shi

  • Study site

    Izumisano

  • Study site

    Kamakura-shi

  • Study site

    Kanazawa

  • Study site

    Kawanishi-shi

  • Study site

    Koriyama-shi

  • Study site

    Kuki-shi

  • Study site

    Kyoto

  • Study site

    Matsuyama

  • Study site

    Midori

  • Study site

    Minatoku

  • Study site

    Nagoya

  • Study site

    Osaka

  • Study site

    Ota-shi

  • Study site

    Saiki-shi

  • Study site

    Sashima-gun

  • Study site

    Shinjuku-ku

  • Study site

    Toyama

  • Study site

    Uwajima-shi

  • Study site

    Yamanashi

  • Study site

    Yokohama

Other trials in Japan

Brazil22 sites

  • Study site

    Aparecida de Goiânia

  • Study site

    Belém

  • Study site

    Belo Horizonte

  • Study site

    Botucatu

  • Study site

    Brasília

  • Study site

    Campina Grande do Sul

  • Study site

    Campinas

  • Study site

    Canoas

  • Study site

    Caxias do Sul

  • Study site

    Curitiba

  • Study site

    Fortaleza

  • Study site

    Joinville

  • Study site

    Juiz de Fora

  • Study site

    Maringá

  • Study site

    Passo Fundo

  • Study site

    Porto Alegre

  • Study site

    Rio de Janeiro

  • Study site

    Santo André

  • Study site

    São José do Rio Preto

  • Study site

    São José dos Campos

  • Study site

    São Paulo

  • Study site

    Tatuí

Other trials in Brazil

Mexico22 sites

  • Study site

    Aguascalientes

  • Study site

    Celaya

  • Study site

    Chihuahua City

  • Study site

    Ciudad de Mexic

  • Study site

    Cuautitlán Izcalli

  • Study site

    Culiacán

  • Study site

    Durango

  • Study site

    El Salto

  • Study site

    Guadalajara

  • Study site

    León

  • Study site

    Mérida

  • Study site

    México

  • Study site

    Mexico City

  • Study site

    Monterrey

  • Study site

    Morelia

  • Study site

    Orizaba

  • Study site

    Pachuca

  • Study site

    Querétaro

  • Study site

    San Luis Potosí City

  • Study site

    Tlalnepantla

  • Study site

    Veracruz

  • Study site

    Zapopan

Other trials in Mexico

Spain20 sites

  • Study site

    A Coruña

  • Study site

    Almería

  • Study site

    Barcelona

  • Study site

    Burela de Cabo

  • Study site

    Ciudad Real

  • Study site

    Getafe

  • Study site

    Girona

  • Study site

    Granada

  • Study site

    La Roca del Vallès

  • Study site

    Madrid

  • Study site

    Majadahonda

  • Study site

    Málaga

  • Study site

    Palma de Mallorca

  • Study site

    Pozuelo de Alarcón

  • Study site

    Sagunto

  • Study site

    Santander

  • Study site

    Seville

  • Study site

    Valencia

  • Study site

    Vic

  • Study site

    Viladecans

Other trials in Spain

Canada18 sites

  • Study site

    Brampton, Ontario

  • Study site

    Edmonton, Alberta

  • Study site

    Greenfield Park, Quebec

  • Study site

    London, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    New Westminster, British Columbia

  • Study site

    Newmarket, Ontario

  • Study site

    Oshawa, Ontario

  • Study site

    Québec, Quebec

  • Study site

    Québec

  • Study site

    Smiths Falls, Ontario

  • Study site

    Thornhill, Ontario

  • Study site

    Toronto, Ontario

  • Study site

    Toronto

  • Study site

    Vancouver, British Columbia

  • Study site

    Vancouver

  • Study site

    Weston, Ontario

  • Study site

    Winnipeg, Manitoba

Other trials in Canada

Hungary18 sites

  • Study site

    Baja

  • Study site

    Balatonfüred

  • Study site

    Budapest

  • Study site

    Debrecen

  • Study site

    Eger

  • Study site

    Esztergom

  • Study site

    Gödöllő

  • Study site

    Gyula

  • Study site

    Hu-4012 Debrecen N/a

  • Study site

    Kaposvár

  • Study site

    Kecskemét

  • Study site

    Komárom

  • Study site

    Nyíregyháza

  • Study site

    Pécs

  • Study site

    Szeged

  • Study site

    Szigetvár

  • Study site

    Veszprém

  • Study site

    Zalaegerszeg

Other trials in Hungary

China17 sites

  • Study site

    Beijing

  • Study site

    Changchun

  • Study site

    Changde

  • Study site

    Changsha

  • Study site

    Chengdu

  • Study site

    Chenzhou

  • Study site

    Dalian

  • Study site

    Foshan

  • Study site

    Guangzhou

  • Study site

    Huai'an

  • Study site

    Nanchang

  • Study site

    Nanjing

  • Study site

    Shanghai

  • Study site

    Shenyang

  • Study site

    Ürümqi

  • Study site

    Wuhan

  • Study site

    Xi'an

Other trials in China

Australia16 sites

  • Study site

    Cairns

  • Study site

    Concord

  • Study site

    Darlinghurst

  • Study site

    Elizabeth Vale

  • Study site

    Fremantle

  • Study site

    Gosford

  • Study site

    Heidelberg

  • Study site

    Keswick

  • Study site

    Meadowbrook

  • Study site

    Parkville

  • Study site

    Reservoir

  • Study site

    Richmond

  • Study site

    St Albans

  • Study site

    St Leonards

  • Study site

    Sydney

  • Study site

    Woolloongabba

Other trials in Australia

France16 sites

  • Study site

    Besançon

  • Study site

    Brest

  • Study site

    Colmar

  • Study site

    Corbeil-Essonnes

  • Study site

    Créteil

  • Study site

    Grenoble

  • Study site

    Lyon

  • Study site

    Marseille

  • Study site

    Metz

  • Study site

    Nantes

  • Study site

    Paris

  • Study site

    Pierre-Bénit

  • Study site

    Poitiers

  • Study site

    Saint-Priest-en-Jarez

  • Study site

    Strasbourg

  • Study site

    Toulouse

Other trials in France

Russia16 sites

  • Study site

    Arkhangelsk

  • Study site

    Barnaul

  • Study site

    Ivanovo

  • Study site

    Kemerovo

  • Study site

    Moscow

  • Study site

    Novosibirsk

  • Study site

    Petrozavodsk

  • Study site

    Rostov-on-Don

  • Study site

    Ryazan

  • Study site

    Saint Petersburg

  • Study site

    Saratov

  • Study site

    Sestroretsk, Saint-Petersburg

  • Study site

    Tomsk

  • Study site

    Ufa

  • Study site

    Volgograd

  • Study site

    Yaroslavl

Other trials in Russia

Poland15 sites

  • Study site

    Bydgoszcz

  • Study site

    Chorzów

  • Study site

    Katowice

  • Study site

    Krakow

  • Study site

    Lodz

  • Study site

    Lublin

  • Study site

    Parczew

  • Study site

    Poznan

  • Study site

    Radom

  • Study site

    Rzeszów

  • Study site

    Torun

  • Study site

    Warswa

  • Study site

    Wroclaw

  • Study site

    Zgierz

  • Study site

    Żnin

Other trials in Poland

India14 sites

  • Study site

    Calicut

  • Study site

    Chennai

  • Study site

    Delhi

  • Study site

    Hyderabad

  • Study site

    Kozhikode

  • Study site

    Lucknow

  • Study site

    Ludhiyāna

  • Study site

    Mangalore

  • Study site

    Mumbai

  • Study site

    Mysore

  • Study site

    Secunderabad

  • Study site

    Trivandrum

  • Study site

    Vijayawada

  • Study site

    Visakhapatnam

Other trials in India

Czechia13 sites

  • Study site

    České Budějovice

  • Study site

    Český Krumlov

  • Study site

    Choceň

  • Study site

    Havlíčkův Brod

  • Study site

    Hradec Kralove-Vekose

  • Study site

    Hradec nad Svitavou

  • Study site

    Jindřichův Hradec

  • Study site

    Olomouc

  • Study site

    Prague

  • Study site

    Slaný

  • Study site

    Trutnov

  • Study site

    Uherské Hradiště

  • Study site

    Ústí nad Labem

Other trials in Czechia

Malaysia13 sites

  • Study site

    Batu Caves

  • Study site

    Ipoh

  • Study site

    Johor Bahru

  • Study site

    Kuala Lumpur

  • Study site

    Kuantan

  • Study site

    Malacca

  • Study site

    Perai

  • Study site

    Petaling Jaya

  • Study site

    Seremban

  • Study site

    Seri Manjung

  • Study site

    Sungai Petani, Kedah

  • Study site

    Tampin

  • Study site

    Temerluh

Other trials in Malaysia

Philippines13 sites

  • Study site

    Cagayan de Oro

  • Study site

    Cebu

  • Study site

    Cebuu City

  • Study site

    Davao City

  • Study site

    Iloilo City

  • Study site

    Lipa City

  • Study site

    Marikina City

  • Study site

    Pasay

  • Study site

    Pasig

  • Study site

    Quezon City

  • Study site

    San Fernando City

  • Study site

    Tagbilaran City

  • Study site

    Taytay

Other trials in Philippines

Slovakia11 sites

  • Study site

    Bardejov

  • Study site

    Bratislava

  • Study site

    Košice

  • Study site

    Ľubochňa

  • Study site

    Nitra

  • Study site

    Prievidza

  • Study site

    Púchov

  • Study site

    Rimavská Sobota

  • Study site

    Štúrovo

  • Study site

    Svidník

  • Study site

    Žilina

Other trials in Slovakia

Ukraine10 sites

  • Study site

    Chernivtsi

  • Study site

    Dnipropetrovsk

  • Study site

    Ivano-Frankivsk

  • Study site

    Kharkiv

  • Study site

    Kiev

  • Study site

    Kyiv

  • Study site

    Ternopil

  • Study site

    Vinnitsya

  • Study site

    Vinnytsia

  • Study site

    Zaporizhzhya

Other trials in Ukraine

Colombia9 sites

  • Study site

    Barranquilla

  • Study site

    Bogotá

  • Study site

    Bucaramanga

  • Study site

    Cali

  • Study site

    Floridablanca

  • Study site

    Manizales

  • Study site

    Medellín

  • Study site

    Pasto

  • Study site

    Pereira

Other trials in Colombia

Romania9 sites

  • Study site

    Brasov

  • Study site

    Bucharest

  • Study site

    Cluj-Napoca

  • Study site

    Deva

  • Study site

    Iași

  • Study site

    Oradea

  • Study site

    Ploieşti

  • Study site

    Târgu Mureş

  • Study site

    Timișoara

Other trials in Romania

South Africa9 sites

  • Study site

    Cape Town

  • Study site

    Durban

  • Study site

    Isipingo Rail

  • Study site

    Johannesburg

  • Study site

    Krugersdorp

  • Study site

    Port Elizabeth

  • Study site

    Pretoria

  • Study site

    Pretoria Gauteng

  • Study site

    Soweto

Other trials in South Africa

Bulgaria8 sites

  • Study site

    Blagoevgrad

  • Study site

    Byala

  • Study site

    Golenci

  • Study site

    Pazardzhik

  • Study site

    Pleven

  • Study site

    Plovdiv

  • Study site

    Sofia

  • Study site

    Varna

Other trials in Bulgaria

Germany8 sites

  • Study site

    Bad Kreuznach - Bosenheim

  • Study site

    Cologne

  • Study site

    Dietzenbach

  • Study site

    Dresden

  • Study site

    Essen

  • Study site

    Hamburg

  • Study site

    Hanover

  • Study site

    Münster

Other trials in Germany

New Zealand8 sites

  • Study site

    Auckland

  • Study site

    Christchurch

  • Study site

    Dunedin

  • Study site

    Palmerston North

  • Study site

    Rotorua

  • Study site

    Takapuna Auckland

  • Study site

    Tauranga

  • Study site

    Wellington

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    Busan

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    Daegu

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    Incheon

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    Seongnam

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    Seoul

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    Kaohsiung City

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    New Taipei City

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    Taichung

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    Taipei

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    Concepción

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    Temuco

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    Šiauliai

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    San Juan

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    Zaječar

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    Sharjah city

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    Guatemala City

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About this study

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

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).

Read the 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.

Being tested
Canagliflozin, Placebo
Keywords
Diabetes Mellitus, Type 2, Diabetic Nephropathies, Canagliflozin, JNJ-28431754, End-Stage Kidney Disease, Chronic Kidney Disease, Macroalbuminuria
Medical subject headings
Diabetes Mellitus, Type 2, Diabetic Nephropathies, Kidney Failure, Chronic, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CanagliflozinDrug

    One 100 mg over-encapsulated tablet orally once daily

  • PlaceboDrug

    One matching placebo capsule orally (by mouth) once daily

Study groups in NCT02065791
Study groupRoleWhat they receive
Canagliflozin 100 mgExperimentalEach participant will receive 100 mg of canagliflozin once daily
Receives: Drug: Canagliflozin
PlaceboPlacebo comparatorEach participant will receive matching placebo once daily
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Composite Endpoint of Doubling of Serum Creatinine (DoSC), End-stage Kidney Disease (ESKD), and Renal or Cardiovascular (CV) Death

    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.

    Measured: Up to 4.6 years

Secondary outcomes (7)

  1. Composite Endpoint of CV Death and Hospitalized Heart Failure (HHF)

    The composite endpoint included CV death and HHF. CV death included death due to myocardial infarction (MI), stroke, heart failure, sudden death, death during a CV procedure or as a result of procedure-related complications, or death due to other CV causes. For analytic purposes, undetermined causes of death were considered CV deaths. In determining whether a death event was CV in nature, the EAC took into consideration both the proximate and underlying causes. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of the composite endpoint of CV death and HHF are presented.

    Measured: Up to 4.6 years

  2. Major Adverse Cardiac Event (MACE)

    The composite endpoint included CV death, non-fatal MI, and non-fatal stroke (that is, 3-point MACE). Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of MACE are presented.

    Measured: Up to 4.6 years

  3. Hospitalized Heart Failure (HHF)

    Adjudication of these events by the Endpoint Adjudication Committee (EAC) was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of hospitalized heart failure are presented.

    Measured: Up to 4.6 years

  4. Renal Composite Endpoint

    The renal composite endpoint included composite of DoSC, ESKD and Renal death. DoSC: from the baseline average determination (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). ESKD: initiation of maintenance dialysis for at least 30 days, or renal transplantation, or an eGFR value of <15 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 have reached ESKD, died without initiating renal replacement therapy, and no other cause of death was determined via adjudication. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of the renal composite endpoint are presented.

    Measured: Up to 4.6 years

  5. Cardiovascular (CV) Death

    CV death included death due to MI, stroke, heart failure, sudden death, death during a CV procedure or as a result of procedure-related complications, or death due to other CV causes. For analytic purposes, undetermined causes of death were considered CV deaths. In determining whether a death event was a CV in nature, the EAC took into consideration both the proximate and underlying causes. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of CV death are presented.

    Measured: Up to 4.6 years

  6. All-cause Mortality

    Adjudication of these events by Endpoint Adjudication Committee (EAC) was performed in a blinded fashion. Event rate estimated based on time to first occurrence of all-cause mortality are presented.

    Measured: Up to 4.6 years

  7. CV Composite Endpoint

    The CV composite endpoint included the CV death, non-fatal MI, non-fatal stroke, hospitalized heart failure, and hospitalized unstable angina. CV death included death due to MI, stroke, heart failure, sudden death, death during a CV procedure or as a result of procedure-related complications, or death due to other CV causes. For analytic purposes, undetermined causes of death were considered CV deaths. In determining whether a death event was a CV in nature, the EAC took into consideration both the proximate and underlying causes. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of the CV composite endpoint are presented.

    Measured: Up to 4.6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2014 (estimated)
  2. Study start17 Feb 2014
  3. Primary completion30 Oct 2018
  4. Study completion30 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
4,401 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02065791
Sponsor's protocol ID
CR103517
Other IDs
2013-004494-28, 28431754DNE3001
Acronym
CREDENCE
Status last verified
Dec 2019
First submitted
17 Feb 2014
Last updated
5 Dec 2019
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Li J, Gonzalez Villalobos RA, Rutkoski TJ, Farrington KP, Chipashvili V, Zheng G, Chen T, Yekkala K, Locatelli M, Zoja C, Benigni A, Lutnick B, Ho G, Reilly D, Zheng X, Zheng S, Bialecki R, Hansen MK, Wu H, Humphreys BD, Magnone MC, Myshkin E, Breyer MD. Vascular Endothelial Growth Factor Receptor 1-Blocking Antibody Improves Endothelial Structure, Kidney Function, and GFR in Diabetic Mice. J Am Soc Nephrol. 2026 Sep 1. doi: 10.1681/ASN.0000001176. Online ahead of print.

    PubMed 42475421

  • Moedt E, Koshino A, Jongs N, Ju W, Nair V, Kretzler M, Hansen MK, Arnott CG, Wheeler DC, Rossing P, Coca SG, Hammarstedt A, Greasley PJ, Bjornstad P, Bakker SJL, Heerspink HJL. Association of Urinary EGF with Kidney Outcomes and Effects of Sodium-Glucose Cotransporter 2 Inhibition. J Am Soc Nephrol. 2026 Apr 2. doi: 10.1681/ASN.0000001086. Online ahead of print.

    PubMed 41926219

  • Chiriaco M, Trico D, Giannoni A, Sacchetta L, Nesti L, Baldi S, Scozzaro T, Castiglione V, Natali A, Ferrannini E. Impact of canagliflozin on the cardiorenal effects of dietary sodium intake in type 2 diabetes: a post hoc analysis of the CREDENCE trial. Diabetologia. 2026 Jul;69(7):1806-1817. doi: 10.1007/s00125-026-06705-6. Epub 2026 Mar 12.

    PubMed 41817689

  • Heerspink HJL, Collier WH, Chaudhari J, Miao S, Tighiouart H, Appel GB, Caravaca-Fontan F, Floege J, Hannedouche T, Imai E, Jafar TH, Lewis JB, Li PKT, Locatelli F, Maes BD, Neuen BL, Perkovic V, Perrone RD, Remuzzi G, Schena FP, Wanner C, Greene T, Inker LA. A meta-analysis of albuminuria as a surrogate endpoint for kidney failure. Nat Med. 2026 Jan;32(1):281-287. doi: 10.1038/s41591-025-04057-z. Epub 2025 Nov 6.

    PubMed 41198855

  • Mottl A, Scott C, Green JB, Heerspink HJL, Mann JFE, McGill JB, Nangaku M, Rosenstock J, Rossing P, Li L, Li N, Vaduganathan M, Agarwal R; CONFIDENCE Trial Investigators. Baseline Kidney Function, Albuminuria, and Urine Albumin-Creatinine Ratio Reduction with Finerenone, Empagliflozin, or Both: Post Hoc Analyses of CONFIDENCE Trial. J Am Soc Nephrol. 2026 Apr 1;37(4):764-776. doi: 10.1681/ASN.0000000928. Epub 2025 Nov 6.

    PubMed 41196655

  • Bayes-Genis A, Cai A, Liu Y, Pandey A, Pop-Busui R, Hansen M, Januzzi JL. Impact of canagliflozin on heart stress and outcomes: Pooled insights from CREDENCE and CANVAS. Eur J Heart Fail. 2025 Dec;27(12):2887-2896. doi: 10.1002/ejhf.3786. Epub 2025 Jul 21.

    PubMed 40689549

  • Oshima M, Buizen L, Jongs N, Levin A, Chertow GM, Wheeler DC, Heerspink HJL, Arnott C, Jardine MJ, Mahaffey KW, Pollock C, Herrington WG, Perkovic V, Neuen BL. Sodium-Glucose Cotransporter 2 Inhibition and Hospitalizations in Patients with CKD: A Meta-Analysis of Kidney Outcome Trials. Clin J Am Soc Nephrol. 2025 Jul 14;20(9):1206-1214. doi: 10.2215/CJN.0000000771.

    PubMed 40658498

  • Jongs N, Gasparyan SB, Frison L, Schloemer P, Brinker M, Little DJ, Heerspink HJL. Use of eGFR Slope Thresholds as End Point Components in a Kidney Disease Progression Hierarchical Composite End Point. J Am Soc Nephrol. 2025 Dec 1;36(12):2421-2430. doi: 10.1681/ASN.0000000766. Epub 2025 Jun 17.

    PubMed 40526444

  • Januzzi JLJ, Sattar N, Vaduganathan M, Magaret CA, Rhyne RF, Liu Y, Masson S, Butler J, Hansen MK. A validated multivariable machine learning model to predict cardio-kidney risk in diabetic kidney disease. Cardiovasc Diabetol. 2025 May 15;24(1):213. doi: 10.1186/s12933-025-02779-5.

    PubMed 40375260

  • Doi Y, Hamano T, Yamaguchi O, Isaka Y. Canagliflozin may increase thromboembolic events in males with erythrocytosis but not in females. Blood Adv. 2025 Jul 8;9(13):3202-3212. doi: 10.1182/bloodadvances.2025016320.

    PubMed 40239057

  • Nguyen TN, Yu J, Perkovic V, Jardine M, Mahaffey KW, Chow CK, Arnott C, Lindley RI. The Efficacy and Safety of Canagliflozin by Frailty Status in Participants of the CANVAS and CREDENCE Trials. J Am Geriatr Soc. 2025 Jun;73(6):1787-1796. doi: 10.1111/jgs.19444. Epub 2025 Mar 19.

    PubMed 40105285

  • Chatur S, Vaduganathan M, Fletcher RA, Perkovic V, Heerspink H, Arnott C, Pollock C, Mahaffey KW, Neal B, Jardine M, Solomon SD, Neuen BL. Canagliflozin reduces oral loop diuretic intensification in patients with type 2 diabetes: A participant-level pooled analysis of the CANVAS and CREDENCE trials. Eur J Heart Fail. 2025 Jun;27(6):994-1002. doi: 10.1002/ejhf.3586. Epub 2025 Jan 23.

    PubMed 39844714

  • Ferrannini E, Baldi S, Scozzaro MT, Ferrannini G, Hansen MK. Fasting substrates predict chronic kidney disease progression in CREDENCE trial patients with type 2 diabetes. JCI Insight. 2024 Dec 20;9(24):e180637. doi: 10.1172/jci.insight.180637.

    PubMed 39704168

  • Vaduganathan M, Cannon CP, Jardine MJ, Heerspink HJL, Arnott C, Neuen BL, Sarraju A, Gogate J, Seufert J, Neal B, Perkovic V, Mahaffey KW, Kosiborod MN. Effects of canagliflozin on total heart failure events across the kidney function spectrum: Participant-level pooled analysis from the CANVAS Program and CREDENCE trial. Eur J Heart Fail. 2024 Sep;26(9):1967-1975. doi: 10.1002/ejhf.3292. Epub 2024 Jun 26.

    PubMed 38932575

  • Tangri N, Ferguson TW, Bamforth RJ, Leon SJ, Arnott C, Mahaffey KW, Kotwal S, Heerspink HJL, Perkovic V, Fletcher RA, Neuen BL. Machine learning for prediction of chronic kidney disease progression: Validation of the Klinrisk model in the CANVAS Program and CREDENCE trial. Diabetes Obes Metab. 2024 Aug;26(8):3371-3380. doi: 10.1111/dom.15678. Epub 2024 May 28.

    PubMed 38807510

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Canagliflozin in people with Diabetes Mellitus, Type 2 and Diabetic Nephropathy, run by Janssen Research & Development, LLC at 575 sites in 34 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 575 sites in United States, United Kingdom, Argentina, Japan, Brazil and 29 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02065791, which also lists 47 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2019.

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