Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy
Launched by JANSSEN RESEARCH & DEVELOPMENT, LLC · Feb 17, 2014
Trial Information
Current as of June 10, 2025
Completed
Keywords
ClinConnect Summary
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 (AC...
Gender
ALL
Eligibility 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
About Janssen Research & Development, Llc
Janssen Research & Development, LLC, a subsidiary of Johnson & Johnson, is a leading pharmaceutical company dedicated to advancing innovative therapies in multiple therapeutic areas, including oncology, immunology, neuroscience, infectious diseases, and cardiovascular health. With a strong commitment to scientific excellence and patient-centered research, Janssen leverages cutting-edge technology and collaborative partnerships to drive the development of transformative treatments. The company is focused on addressing unmet medical needs through rigorous clinical trials and a robust pipeline, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
Jacksonville, Florida, United States
Atlanta, Georgia, United States
Indianapolis, Indiana, United States
Kansas City, Missouri, United States
Saint Louis, Missouri, United States
Pittsburgh, Pennsylvania, United States
San Antonio, Texas, United States
Philadelphia, Pennsylvania, United States
Quebec, , Canada
Montreal, Quebec, Canada
Pretoria, , South Africa
Girona, , Spain
Kiev, , Ukraine
San Antonio, Texas, United States
Tucson, Arizona, United States
Denver, Colorado, United States
Miami, Florida, United States
Chicago, Illinois, United States
Boston, Massachusetts, United States
Albuquerque, New Mexico, United States
Charlotte, North Carolina, United States
Philadelphia, Pennsylvania, United States
Knoxville, Tennessee, United States
Houston, Texas, United States
Milwaukee, Wisconsin, United States
Vancouver, British Columbia, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Strasbourg, , France
Krakow, , Poland
Lublin, , Poland
Barcelona, , Spain
Madrid, , Spain
Valencia, , Spain
Bristol, , United Kingdom
London, , United Kingdom
Baltimore, Maryland, United States
New York, New York, United States
Arlington, Texas, United States
Dallas, Texas, United States
Mendoza, , Argentina
Hamburg, , Germany
Budapest, , Hungary
Wroclaw, , Poland
Ponce, , Puerto Rico
Moscow, , Russian Federation
Durban, , South Africa
Palma De Mallorca, , Spain
Taipei, , Taiwan
Buffalo, New York, United States
Birmingham, Alabama, United States
Orange, California, United States
San Diego, California, United States
Washington, District Of Columbia, United States
Augusta, Georgia, United States
Springfield, Massachusetts, United States
Great Neck, New York, United States
New Hyde Park, New York, United States
Greensboro, North Carolina, United States
Memphis, Tennessee, United States
Debrecen, , Hungary
Pecs, , Hungary
Poznan, , Poland
Winter Park, Florida, United States
Las Vegas, Nevada, United States
Little Rock, Arkansas, United States
Chula Vista, California, United States
Long Beach, California, United States
Lincoln, Nebraska, United States
Buffalo, New York, United States
Salt Lake City, Utah, United States
Stanford, California, United States
Worcester, Massachusetts, United States
Cincinnati, Ohio, United States
Hawthorne, California, United States
Waco, Texas, United States
Fountain Valley, California, United States
Louisville, Kentucky, United States
Scarborough, Maine, United States
Omaha, Nebraska, United States
Columbia, South Carolina, United States
Cali, , Colombia
Muncie, Indiana, United States
Fort Worth, Texas, United States
Sacramento, California, United States
Silver Spring, Maryland, United States
Edmonton, Alberta, Canada
Winnipeg, Manitoba, Canada
Auckland, , New Zealand
Wellington, , New Zealand
Buenos Aires, , Argentina
Rio De Janeiro, , Brazil
Essen, , Germany
Mexico City, , Mexico
San Juan, , Puerto Rico
Albany, New York, United States
Chattanooga, Tennessee, United States
Edmonton, Alberta, Canada
Northridge, California, United States
Bydgoszcz, , Poland
Arkhangelsk, , Russian Federation
Novosibirsk, , Russian Federation
Ryazan, , Russian Federation
St. Petersburg, , Russian Federation
Coral Springs, Florida, United States
Bakersfield, California, United States
Greenville, North Carolina, United States
Spokane, Washington, United States
Plymouth, Devon, United Kingdom
Durham, North Carolina, United States
Norfolk, Virginia, United States
Covina, California, United States
Saint Petersburg, Florida, United States
Raleigh, North Carolina, United States
Corrientes, , Argentina
Rosario, , Argentina
San Martin, , Argentina
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Besancon Cedex, , France
Colmar N/A, , France
Paris, , France
Dresden, , Germany
Katowice, , Poland
Bucuresti, , Romania
Cluj Napoca, , Romania
Iasi, , Romania
Targu Mures, , Romania
Santander, , Spain
Antrim, , United Kingdom
Durham, , United Kingdom
Plymouth, , United Kingdom
Paducah, Kentucky, United States
Jackson, Mississippi, United States
Merida, , Mexico
Zalaegerszeg, , Hungary
Olomouc, , Czechia
Praha, , Czechia
Kaohsiung, , Taiwan
Fort Worth, Texas, United States
Fort Wayne, Indiana, United States
Palmerston North, , New Zealand
Hannover, , Germany
Seoul, , Korea, Republic Of
Pasadena, California, United States
Birmingham, , United Kingdom
Kenner, Louisiana, United States
Paris, , France
Christchurch, , New Zealand
Bennington, Vermont, United States
Oakland, California, United States
Darlinghurst, , Australia
Soweto, , South Africa
Pecs, , Hungary
Augusta, Georgia, United States
Campinas, , Brazil
Curitiba, , Brazil
Sao Paulo, , Brazil
Santa Fe, , Argentina
Sydney, , Australia
Santiago, , Chile
Bogota, , Colombia
Medellin, , Colombia
Johannesburg, , South Africa
Burlington, Vermont, United States
New Westminster, British Columbia, Canada
Greenfield Park, Quebec, Canada
Temuco, , Chile
Newmarket, Ontario, Canada
Varna, , Bulgaria
Zalaegerszeg, , Hungary
Kaunas, , Lithuania
Lodz, , Poland
Timisoara, , Romania
Barnaul, , Russian Federation
Ivanovo, , Russian Federation
Petrozavodsk, , Russian Federation
Tomsk, , Russian Federation
Volgograd, , Russian Federation
Yaroslavl, , Russian Federation
Nis, , Serbia
Cape Town, , South Africa
Port Elizabeth, , South Africa
Pretoria Gauteng, , South Africa
Sevilla, , Spain
Chernivtsi, , Ukraine
Roseville, California, United States
Golden, Colorado, United States
Asheville, North Carolina, United States
Grenoble, , France
Bradford, , United Kingdom
Sumter, South Carolina, United States
Guatemala City, , Guatemala
Port Charlotte, Florida, United States
Saint Petersburg, , Russian Federation
Bratislava, , Slovakia
Taichung, , Taiwan
St. Petersburg, , Russian Federation
Ocala, Florida, United States
Porto Alegre, , Brazil
La Plata, , Argentina
Thornhill, Ontario, Canada
Auckland, , New Zealand
London, Ontario, Canada
Ryazan, , Russian Federation
Beijing, , China
Köln, , Germany
Ciudad De Mexico, , Mexico
Cordoba, , Argentina
Guatemala, , Guatemala
Kuala Lumpur, , Malaysia
Guadalajara, , Mexico
Columbus, Georgia, United States
Hialeah, Florida, United States
Monterrey, , Mexico
Kharkiv, , Ukraine
Kyiv, , Ukraine
Flint, Michigan, United States
St Leonards, , Australia
Belo Horizonte, , Brazil
Santo Andre, , Brazil
Guangzhou, , China
Shanghai, , China
Saint Petersburg, , Russian Federation
Girona, , Spain
Chennai, , India
Mumbai, , India
San Luis Potosi, , Mexico
Concord, New South Wales, Australia
Grenoble, , France
Salta, , Argentina
Kyoto, , Japan
Hyderabad, , India
Kosice, , Slovakia
Rimavska Sobota, , Slovakia
Sherwood, Arkansas, United States
Gurnee, Illinois, United States
Sugar Land, Texas, United States
Fremantle, , Australia
Heidelberg, , Australia
Fukuoka, , Japan
Tauranga, , New Zealand
Getafe, , Spain
Corpus Christi, Texas, United States
Chesterfield, Missouri, United States
Beaver, Pennsylvania, United States
Ceske Budejovice, , Czechia
Praha 5, , Czechia
Bahia Blanca, , Argentina
Mar Del Plata, , Argentina
Pleven, , Bulgaria
Uherske Hradiste, , Czechia
Ivano Frankivsk, , Ukraine
Kaposvar, , Hungary
Nyiregyhaza, , Hungary
Radom, , Poland
Torun, , Poland
Lucknow, , India
Cardiff, , United Kingdom
Montgomery, Alabama, United States
Praha 2, , Czechia
Klaipeda, , Lithuania
Siauliai, , Lithuania
Mexico, , Mexico
Belgrade, , Serbia
Usti Nad Labem, , Czechia
Zgierz, , Poland
Nitra, , Slovakia
Granada, , Spain
Inglewood, California, United States
Poitiers, , France
Trivandrum, , India
Aguascalientes, , Mexico
Chihuahua, , Mexico
Zapopan, , Mexico
Praha 4, , Czechia
Cairns, , Australia
Parkville, , Australia
Zilina, , Slovakia
Stoke On Trent, , United Kingdom
High Point, North Carolina, United States
Tustin, California, United States
Anderson, South Carolina, United States
Suffolk, Virginia, United States
Dresden, Sachsen, Germany
Busan, , Korea, Republic Of
Daegu, , Korea, Republic Of
Incheon, , Korea, Republic Of
Dietzenbach, , Germany
Dnipropetrovsk, , Ukraine
Lyon Cedex 03, , France
Toulouse Cedex 9, , France
Nantes Cedex 01, , France
Ciudad Real, , Spain
Cardiff, , United Kingdom
Salford, , United Kingdom
Christchurch, , New Zealand
Praha 10, , Czechia
Gyula, , Hungary
Szeged N/A, , Hungary
Swansea, , United Kingdom
Durango, , Mexico
Columbus, Georgia, United States
Roswell, Georgia, United States
Quilmes, , Argentina
Middlesbrough, , United Kingdom
Nanjing, , China
Shenyang, , China
Petaling Jaya, , Malaysia
Salinas, California, United States
Ipoh, , Malaysia
Veracruz, , Mexico
Vic, , Spain
Oshawa, Ontario, Canada
Binghamton, New York, United States
Corsicana, Texas, United States
Jackson, Tennessee, United States
Temple, Texas, United States
Snellville, Georgia, United States
Gyula, , Hungary
Saratov, , Russian Federation
Bethlehem, Pennsylvania, United States
San Miguel De Tucuman, , Argentina
Muenster, , Germany
Aguascalientes, , Mexico
Brasov, , Romania
Secunderabad, , India
Cebu, , Philippines
Rotorua, , New Zealand
Lake Success, New York, United States
Hyattsville, Maryland, United States
Changsha, , China
Northridge, California, United States
Winfield, Illinois, United States
Annapolis, Maryland, United States
Morehead City, North Carolina, United States
Laguna Hills, California, United States
Whittier, California, United States
Komarom, , Hungary
Dunedin, , New Zealand
Porto Alegre, Rio Grande Do Sul, Brazil
Botucatu, , Brazil
Brasilia, , Brazil
Brest Cedex, , France
Tempe, Arizona, United States
Stockbridge, Georgia, United States
Rzeszow, , Poland
Bydgoszcz, , Poland
Barranquilla, , Colombia
Guadalajara, Jalisco, Mexico
Johannesburg, Gauteng, South Africa
Joinville, , Brazil
Havlickuv Brod, , Czechia
Blackburn, , United Kingdom
Veszprem, , Hungary
Rostov On Don, , Russian Federation
Concord, , Australia
Delhi, , India
Mangalore, , India
Leon, , Mexico
Morelia, , Mexico
Davao City, , Philippines
Iloilo City, , Philippines
Quezon City, , Philippines
Ufa, , Russian Federation
Vinnytsia, , Ukraine
North Miami Beach, Florida, United States
Xian, , China
Málaga, , Spain
Paris Cedex 15, , France
Campinas, Sao Paulo, Brazil
Bucaramanga, , Colombia
Floridablanca, , Colombia
Takapuna Auckland, , New Zealand
Aberdeen, , United Kingdom
Darlington, , United Kingdom
Krugersdorp, , South Africa
Huntington, West Virginia, United States
Pretoria, Gauteng, South Africa
Wuhan, , China
Brest Cedex, , France
Wroclaw, , Poland
Orangeburg, South Carolina, United States
Córdoba, , Argentina
Eger, , Hungary
Chengdu, Sichuan, China
Merrillville, Indiana, United States
Beltsville, Maryland, United States
Maumee, Ohio, United States
Gosford, , Australia
Reservoir, , Australia
Campina Grande Do Sul, , Brazil
Fortaleza, , Brazil
São Paulo, , Brazil
Brampton, Ontario, Canada
Changchun, , China
Chengdu, , China
Dalian, , China
Mysore, , India
Queretaro, , Mexico
Cebuu City, , Philippines
Oradea, , Romania
Kemerovo, , Russian Federation
A Coruna, , Spain
Almeria, , Spain
Ternopil, , Ukraine
Vinnitsya, , Ukraine
Bournemouth, , United Kingdom
Morganton, North Carolina, United States
Woolloongabba, , Australia
Baja, , Hungary
Downey, California, United States
Smithtown, New York, United States
Jindrichuv Hradec, , Czechia
Trutnov, , Czechia
Sao Paulo, , Brazil
Québec, Quebec, Canada
St Leonards, New South Wales, Australia
São Paulo, Sao Paulo, Brazil
Daegu, , Korea, Republic Of
Palmerston North, , New Zealand
Poznan, , Poland
Taipei, , Taiwan
Lynwood, California, United States
San Dimas, California, United States
Plymouth, Massachusetts, United States
Springfield Gardens, New York, United States
Caguas, , Puerto Rico
Whittier, California, United States
Baja, , Hungary
Nagoya Shi, Aichi, Japan
Yokohama Shi, Kanagawa, Japan
Pereira, , Colombia
Manizales, , Colombia
Sao Jose Do Rio Preto, , Brazil
Changsha, Hunan, China
Elizabeth Vale, , Australia
Kuala Lumpur N/A, , Malaysia
Balatonfured, , Hungary
Moron, , Argentina
Esztergom, , Hungary
Calicut, , India
Eatontown, New Jersey, United States
San Luis, , Argentina
Juiz De Fora, , Brazil
Concepcion, , Chile
Kozhikode, , India
Wolverhampton, , United Kingdom
Fremont, Nebraska, United States
Bardejov, , Slovakia
Bolton, , United Kingdom
Kuantan, , Malaysia
Melaka, , Malaysia
Seremban, , Malaysia
Tempe, Arizona, United States
Rockport, Maine, United States
Culiacan, , Mexico
Seoul, , Korea, Republic Of
Taichung, , Taiwan
Hampstead, , United Kingdom
Murrells Inlet, South Carolina, United States
Kansas City, Missouri, United States
Ploiesti, , Romania
Calabash, North Carolina, United States
Tabor City, North Carolina, United States
Monterrey, Nuevo Leon, Mexico
San Dimas, California, United States
Fort Wayne, Indiana, United States
Zaporizhzhia, , Ukraine
Bluefield, Virginia, United States
Las Vegas, Nevada, United States
Richmond, , Australia
Mesquite, Texas, United States
Shinjuku Ku, , Japan
Kanazawa, , Japan
Izumisano, , Japan
Chorzow, , Poland
Mechanicsville, Virginia, United States
Miami Springs, Florida, United States
Blagoevgrad, , Bulgaria
Lakewood, California, United States
Council Bluffs, Iowa, United States
Godoy Cruz, , Argentina
Caxias Do Sul, , Brazil
Passo Fundo, , Brazil
Nanchang, , China
Cesky Krumlov, , Czechia
Slany, , Czechia
Yokohama Shi, , Japan
Huntingdon, , United Kingdom
Welwyn Garden City, , United Kingdom
Junin, , Argentina
Vijayawada, , India
Yokohama City, , Japan
Marikina City, , Philippines
Sestroretsk, Saint Petersburg, , Russian Federation
Doral, Florida, United States
Busan, , Korea, Republic Of
Lancaster, South Carolina, United States
Minato Ku, , Japan
Smiths Falls, Ontario, Canada
Barcelona, Cataluña, Spain
Johor, , Malaysia
Barnaul, , Russian Federation
Rockport, Maine, United States
Edinburg, Texas, United States
Ramos Mejia, , Argentina
Villa Maria, , Argentina
Batu Caves, , Malaysia
Pachuca, , Mexico
Svidnik, , Slovakia
Doncaster, , United Kingdom
Lubochna, , Slovakia
Majadahonda, , Spain
Wellington, , New Zealand
Yamanashi, , Japan
Schertz, Texas, United States
Prievidza, , Slovakia
Marseille Cedex 05, , France
Celaya, , Mexico
Viladecans, , Spain
Pasig, , Philippines
Westcliff On Sea, , United Kingdom
Meadowbrook, , Australia
Seongnam, , Korea, Republic Of
Ciudad Autonoma Buenos Aires, , Argentina
Praha 5, , Czechia
Dubai, , United Arab Emirates
Parana, , Argentina
Lynwood, California, United States
Paris Cedex 18, , France
Sagunto, , Spain
Leon, Guanajuato, Mexico
Chester, , United Kingdom
Pazardzhik, , Bulgaria
Parczew, , Poland
Byala, , Bulgaria
Crystal Lake, Illinois, United States
New Taipei City, , Taiwan
Lipa City, , Philippines
Taytay, , Philippines
Santo André, , Brazil
Godollo, , Hungary
Sturovo, , Slovakia
Koriyama Shi, , Japan
Usti Nad Labem, , Czechia
Rostov On Don, , Russian Federation
Burbage, , United Kingdom
Leamington Spa, , United Kingdom
Vishakhapatnam, , India
Pachuca De Soto, , Mexico
Carmarthen, , United Kingdom
Changchun, Jilin, China
Quezon City, , Philippines
New Taipei City, , Taiwan
San Nicolas, , Argentina
Belém, , Brazil
Canoas, , Brazil
Tatuí, , Brazil
Osaka Shi, , Japan
Chiyoda Ku, , Japan
Ridgewood, New York, United States
Nagoya Shi, , Japan
Kyoto, , Japan
Zarate, Buenos Aires, , Argentina
St Priest En Jarez, , France
Belo Horizonte, Minas Gerais, Brazil
Chihuahua, , Mexico
Szigetvar, , Hungary
Puchov, , Slovakia
Palma De Mallorca, Illes Balears, Spain
Santo André, Sao Paulo, Brazil
Merida, Yucatán, Mexico
Washington, Colorado, United States
Mount Prospect, Illinois, United States
Michigan City, Indiana, United States
Reno, Nebraska, United States
Riverhead, New York, United States
Whiteville, North Carolina, United States
Roseburg, Oregon, United States
La Plata Lpl Lpl, , Argentina
Munro, , Argentina
San Migeul De Tucuman, , Argentina
Sarandi, , Argentina
Tapiales, , Argentina
Temperley, , Argentina
Keswick, , Australia
St Albans, , Australia
Aparecida De Goiânia, , Brazil
Maringá, , Brazil
São José Dos Campos, , Brazil
Gulyantsi, , Bulgaria
Weston, Ontario, Canada
Changde, , China
Chenzhou, , China
Foshan, , China
Huai'an, , China
Wulumuqi, , China
Pasto, , Colombia
Chocen, , Czechia
Hradec Kralove Vekose, , Czechia
Hradec Nad Svitavou, , Czechia
Corbeil Essonnes Cedex, , France
Créteil Cedex, , France
Metz Cedex 03, , France
Pierre Bénit, , France
Bad Kreuznach Bosenheim, , Germany
Hu 4012 Debrecen N/A, , Hungary
Kecskemet N/A, , Hungary
Ludhiyana, , India
Ageo Shi, , Japan
Hamamatsu Shi, , Japan
Hamura Shi, , Japan
Ina Shi, , Japan
Kamakura Shi, , Japan
Kawanishi Shi, , Japan
Kuki Shi, , Japan
Matsuyama Shi, , Japan
Midori Shi, , Japan
Ota Shi, , Japan
Saiki Shi, , Japan
Sashima Gun, , Japan
Toyama Shi, , Japan
Uwajima Shi, , Japan
Perai, , Malaysia
Seri Manjung, , Malaysia
Sungai Petani, Kedah, , Malaysia
Tampin, , Malaysia
Temerloh, , Malaysia
Ciudad De Mexic, , Mexico
Cuautitlan Izcalli, , Mexico
Culiacán, , Mexico
El Salto, , Mexico
Orizaba, , Mexico
Tlalnepantla De Baz, , Mexico
Cagayan De Oro City, , Philippines
Pasay City, , Philippines
San Fernando, , Philippines
Tagbilaran City, , Philippines
Warswa, , Poland
Znin, , Poland
Deva, , Romania
Zajecar, , Serbia
Isipingo Rail, , South Africa
Burela, , Spain
La Roca Del Vallès, , Spain
Pozuelo De Alarcón, , Spain
Ajman, , United Arab Emirates
Sharjah, , United Arab Emirates
Barry, , United Kingdom
Cardff, , United Kingdom
Carlshalton, , United Kingdom
Ely, , United Kingdom
Harlow, , United Kingdom
Liskeard, , United Kingdom
Rhyl, , United Kingdom
Rugby, , United Kingdom
Torpoint, , United Kingdom
Watford, , United Kingdom
Wokingham, , United Kingdom
Patients applied
Trial Officials
Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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