Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy
NCT ID: NCT02065791
Last Updated: 2019-12-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
4401 participants
INTERVENTIONAL
2014-02-17
2018-10-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Canagliflozin 100 mg
Each participant will receive 100 mg of canagliflozin once daily
Canagliflozin
One 100 mg over-encapsulated tablet orally once daily
Placebo
Each participant will receive matching placebo once daily
Placebo
One matching placebo capsule orally (by mouth) once daily
Interventions
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Canagliflozin
One 100 mg over-encapsulated tablet orally once daily
Placebo
One matching placebo capsule orally (by mouth) once daily
Eligibility Criteria
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Inclusion Criteria
* 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 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
30 Years
ALL
No
Sponsors
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The George Institute for Global Health, Australia
OTHER
Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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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 Martín, , 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
Botucatu, , Brazil
Brasília, , Brazil
Campina Grande do Sul, , Brazil
Campinas, , Brazil
Canoas, , Brazil
Caxias do Sul, , Brazil
Curitiba, , Brazil
Fortaleza, , Brazil
Joinville, , Brazil
Juiz de Fora, , Brazil
Maringá, , Brazil
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Porto Alegre, , Brazil
Rio de Janeiro, , Brazil
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São José do Rio Preto, , Brazil
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São Paulo, , Brazil
Tatuí, , Brazil
Blagoevgrad, , Bulgaria
Byala, , Bulgaria
Golenci, , Bulgaria
Pazardzhik, , Bulgaria
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Sofia, , Bulgaria
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Edmonton, Alberta, Canada
New Westminster, British Columbia, Canada
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Brampton, Ontario, Canada
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Québec, , Canada
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Concepción, , Chile
Santiago, , Chile
Temuco, , Chile
Beijing, , China
Changchun, , China
Changde, , China
Changsha, , China
Chengdu, , China
Chenzhou, , China
Dalian, , China
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Huai'an, , China
Nanchang, , China
Nanjing, , China
Shanghai, , China
Shenyang, , China
Ürümqi, , China
Wuhan, , China
Xi'an, , China
Barranquilla, , Colombia
Bogotá, , Colombia
Bucaramanga, , Colombia
Cali, , Colombia
Floridablanca, , Colombia
Manizales, , Colombia
Medellín, , Colombia
Pasto, , Colombia
Pereira, , Colombia
Choceň, , Czechia
České Budějovice, , Czechia
Český Krumlov, , Czechia
Havlíčkův Brod, , Czechia
Hradec Kralove-Vekose, , Czechia
Hradec nad Svitavou, , Czechia
Jindřichův Hradec, , Czechia
Olomouc, , Czechia
Prague, , Czechia
Slaný, , Czechia
Trutnov, , Czechia
Uherské Hradiště, , Czechia
Ústí nad Labem, , Czechia
Besançon, , France
Brest, , France
Colmar, , France
Corbeil-Essonnes, , France
Créteil, , France
Grenoble, , France
Lyon, , France
Marseille, , France
Metz, , France
Nantes, , France
Paris, , France
Pierre-Bénit, , France
Poitiers, , France
Saint-Priest-en-Jarez, , France
Strasbourg, , France
Toulouse, , France
Bad Kreuznach - Bosenheim, , Germany
Cologne, , Germany
Dietzenbach, , Germany
Dresden, , Germany
Essen, , Germany
Hamburg, , Germany
Hanover, , Germany
Münster, , Germany
Guatemala City, , Guatemala
Baja, , Hungary
Balatonfüred, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Eger, , Hungary
Esztergom, , Hungary
Gödöllő, , Hungary
Gyula, , Hungary
Hu-4012 Debrecen N/a, , Hungary
Kaposvár, , Hungary
Kecskemét, , Hungary
Komárom, , Hungary
Nyíregyháza, , Hungary
Pécs, , Hungary
Szeged, , Hungary
Szigetvár, , Hungary
Veszprém, , Hungary
Zalaegerszeg, , Hungary
Calicut, , India
Chennai, , India
Delhi, , India
Hyderabad, , India
Kozhikode, , India
Lucknow, , India
Ludhiyāna, , India
Mangalore, , India
Mumbai, , India
Mysore, , India
Secunderabad, , India
Trivandrum, , India
Vijayawada, , India
Visakhapatnam, , India
Ageo-shi, , Japan
Chiyoda-ku, , Japan
Fukuoka, , Japan
Hamamatsu, , Japan
Hamura-shi, , Japan
Ina-shi, , Japan
Izumisano, , Japan
Kamakura-shi, , Japan
Kanazawa, , Japan
Kawanishi-shi, , Japan
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Kyoto, , Japan
Matsuyama, , Japan
Midori, , Japan
Minatoku, , Japan
Nagoya, , Japan
Osaka, , Japan
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Saiki-shi, , Japan
Sashima-gun, , Japan
Shinjuku-ku, , Japan
Toyama, , Japan
Uwajima-shi, , Japan
Yamanashi, , Japan
Yokohama, , Japan
Kaunas, , Lithuania
Klaipėda, , Lithuania
Šiauliai, , Lithuania
Batu Caves, , Malaysia
Ipoh, , Malaysia
Johor Bahru, , Malaysia
Kuala Lumpur, , Malaysia
Kuantan, , Malaysia
Malacca, , Malaysia
Perai, , Malaysia
Petaling Jaya, , Malaysia
Seremban, , Malaysia
Seri Manjung, , Malaysia
Sungai Petani, Kedah, , Malaysia
Tampin, , Malaysia
Temerluh, , Malaysia
Aguascalientes, , Mexico
Celaya, , Mexico
Chihuahua City, , Mexico
Ciudad de Mexic, , Mexico
Cuautitlán Izcalli, , Mexico
Culiacán, , Mexico
Durango, , Mexico
El Salto, , Mexico
Guadalajara, , Mexico
León, , Mexico
Mexico City, , Mexico
Mérida, , Mexico
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Morelia, , Mexico
Orizaba, , Mexico
Pachuca, , Mexico
Querétaro, , Mexico
San Luis Potosí City, , Mexico
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Auckland, , New Zealand
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Dunedin, , New Zealand
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Takapuna Auckland, , New Zealand
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Wellington, , New Zealand
Cagayan de Oro, , Philippines
Cebu, , Philippines
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Marikina City, , Philippines
Pasay, , Philippines
Pasig, , Philippines
Quezon City, , Philippines
San Fernando City, , Philippines
Tagbilaran City, , Philippines
Taytay, , Philippines
Bydgoszcz, , Poland
Chorzów, , Poland
Katowice, , Poland
Krakow, , Poland
Lodz, , Poland
Lublin, , Poland
Parczew, , Poland
Poznan, , Poland
Radom, , Poland
Rzeszów, , Poland
Torun, , Poland
Warswa, , Poland
Wroclaw, , Poland
Zgierz, , Poland
Żnin, , Poland
Caguas, , Puerto Rico
Ponce, , Puerto Rico
San Juan, , Puerto Rico
Brasov, , Romania
Bucharest, , Romania
Cluj-Napoca, , Romania
Deva, , Romania
Iași, , Romania
Oradea, , Romania
Ploieşti, , Romania
Târgu Mureş, , Romania
Timișoara, , Romania
Arkhangelsk, , Russia
Barnaul, , Russia
Ivanovo, , Russia
Kemerovo, , Russia
Moscow, , Russia
Novosibirsk, , Russia
Petrozavodsk, , Russia
Rostov-on-Don, , Russia
Ryazan, , Russia
Saint Petersburg, , Russia
Saratov, , Russia
Sestroretsk, Saint-Petersburg, , Russia
Tomsk, , Russia
Ufa, , Russia
Volgograd, , Russia
Yaroslavl, , Russia
Belgrade, , Serbia
Niš, , Serbia
Zaječar, , Serbia
Bardejov, , Slovakia
Bratislava, , Slovakia
Košice, , Slovakia
Ľubochňa, , Slovakia
Nitra, , Slovakia
Prievidza, , Slovakia
Púchov, , Slovakia
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Busan, , South Korea
Daegu, , South Korea
Incheon, , South Korea
Seongnam, , South Korea
Seoul, , South Korea
A Coruña, , Spain
Almería, , Spain
Barcelona, , Spain
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Ciudad Real, , Spain
Getafe, , Spain
Girona, , Spain
Granada, , Spain
La Roca del Vallès, , Spain
Madrid, , Spain
Majadahonda, , Spain
Málaga, , Spain
Palma de Mallorca, , Spain
Pozuelo de Alarcón, , Spain
Sagunto, , Spain
Santander, , Spain
Seville, , Spain
Valencia, , Spain
Vic, , Spain
Viladecans, , Spain
Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Chernivtsi, , Ukraine
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Kharkiv, , Ukraine
Kiev, , Ukraine
Kyiv, , Ukraine
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Vinnitsya, , Ukraine
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Ajman, , United Arab Emirates
Dubai, , United Arab Emirates
Sharjah city, , United Arab Emirates
Aberdeen, , United Kingdom
Antrim, , United Kingdom
Barry, , United Kingdom
Birmingham, , United Kingdom
Blackburn, , United Kingdom
Bolton, , United Kingdom
Bournemouth, , United Kingdom
Bradford, , United Kingdom
Bristol, , United Kingdom
Burbage, , United Kingdom
Cardff, , United Kingdom
Cardiff, , United Kingdom
Carlshalton, , United Kingdom
Carmarthen, , United Kingdom
Chester, , United Kingdom
Darlington, , United Kingdom
Doncaster, , United Kingdom
Durham, , United Kingdom
Ely, , United Kingdom
Hampstead, , United Kingdom
Harlow, , United Kingdom
Huntingdon, , United Kingdom
Liskeard, , United Kingdom
London, , United Kingdom
Middlesbrough, , United Kingdom
Plymouth, , United Kingdom
Rhyl, , United Kingdom
Royal Leamington Spa, , United Kingdom
Rugby, , United Kingdom
Salford, , United Kingdom
Stoke-on-Trent, , United Kingdom
Swansea, , United Kingdom
Torpoint, , United Kingdom
Watford, , United Kingdom
Welwyn Garden City, , United Kingdom
Westcliff-on-Sea, , United Kingdom
Wokingham, , United Kingdom
Wolverhampton, , United Kingdom
Countries
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References
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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 Jul 21. doi: 10.1002/ejhf.3786. Online ahead of print.
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.
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 Jun 17. doi: 10.1681/ASN.0000000766. Online ahead of print. No abstract available.
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.
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.
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.
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.
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.
Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
Januzzi JL Jr, Liu Y, Sattar N, Yavin Y, Pollock CA, Butler J, Jardine M, Heerspink HJL, Masson S, Breyer M, Hansen MK. Vascular endothelial growth factors and risk of cardio-renal events: Results from the CREDENCE trial. Am Heart J. 2024 May;271:38-47. doi: 10.1016/j.ahj.2024.02.016. Epub 2024 Feb 22.
Sharma A, Razaghizad A, Joury A, Levin A, Bajaj HS, Mancini GBJ, Wong NC, Slee A, Ang FG, Rapattoni W, Neuen BL, Arnott C, Perkovic V, Mahaffey KW. Primary and Secondary Cardiovascular and Kidney Prevention With Canagliflozin: Insights From the CANVAS Program and CREDENCE Trial. J Am Heart Assoc. 2024 Feb 6;13(3):e031586. doi: 10.1161/JAHA.123.031586. Epub 2024 Jan 19.
Mohebi R, Liu Y, Hansen MK, Yavin Y, Sattar N, Pollock CA, Butler J, Jardine M, Masson S, Heerspink HJL, Januzzi JL Jr. Associations of Angiopoietin 2 and Vascular Endothelial Growth Factor-A Concentrations with Clinical End Points. Clin J Am Soc Nephrol. 2024 Apr 1;19(4):429-437. doi: 10.2215/CJN.0000000000000389. Epub 2023 Dec 14.
Fletcher RA, Jongs N, Chertow GM, McMurray JJV, Arnott C, Jardine MJ, Mahaffey KW, Perkovic V, Rockenschaub P, Rossing P, Correa-Rotter R, Toto RD, Vaduganathan M, Wheeler DC, Heerspink HJL, Neuen BL. Effect of SGLT2 Inhibitors on Discontinuation of Renin-angiotensin System Blockade: A Joint Analysis of the CREDENCE and DAPA-CKD Trials. J Am Soc Nephrol. 2023 Dec 1;34(12):1965-1975. doi: 10.1681/ASN.0000000000000248. Epub 2023 Oct 25.
Heerspink HJL, Jongs N, Schloemer P, Little DJ, Brinker M, Tasto C, Karpefors M, Wheeler DC, Bakris G, Perkovic V, Nkulikiyinka R, Rossert J, Gasparyan SB. Development and Validation of a New Hierarchical Composite End Point for Clinical Trials of Kidney Disease Progression. J Am Soc Nephrol. 2023 Dec 1;34(12):2025-2038. doi: 10.1681/ASN.0000000000000243. Epub 2023 Oct 24.
Yu J, Sweeting AN, Gianacas C, Houston L, Lee V, Fletcher RA, Perkovic V, Li Q, Neuen BL, Berwanger O, Heerspink HJL, de Zeeuw D, Arnott C. The effects of canagliflozin in type 2 diabetes in subgroups defined by population-specific body mass index: Insights from the CANVAS Program and CREDENCE trial. Diabetes Obes Metab. 2023 Dec;25(12):3724-3735. doi: 10.1111/dom.15267. Epub 2023 Sep 6.
Januzzi JL, Mohebi R, Liu Y, Sattar N, Heerspink HJL, Tefera E, Vaduganathan M, Butler J, Yavin Y, Li J, Pollock CA, Perkovic V, Neal B, Hansen MK. Cardiorenal Biomarkers, Canagliflozin, and Outcomes in Diabetic Kidney Disease: The CREDENCE Trial. Circulation. 2023 Aug 22;148(8):651-660. doi: 10.1161/CIRCULATIONAHA.123.065251. Epub 2023 Aug 21.
Mohebi R, Liu Y, Hansen MK, Yavin Y, Sattar N, Pollock CA, Butler J, Jardine M, Masson S, Heerspink HJL, Januzzi JL Jr. Insulin growth factor axis and cardio-renal risk in diabetic kidney disease: an analysis from the CREDENCE trial. Cardiovasc Diabetol. 2023 Jul 12;22(1):176. doi: 10.1186/s12933-023-01916-2.
Fletcher RA, Arnott C, Rockenschaub P, Schutte AE, Carpenter L, Vaduganathan M, Agarwal R, Bakris G, Chang TI, Heerspink HJL, Jardine MJ, Mahaffey KW, Neal B, Pollock C, Jun M, Rodgers A, Perkovic V, Neuen BL. Canagliflozin, Blood Pressure Variability, and Risk of Cardiovascular, Kidney, and Mortality Outcomes: Pooled Individual Participant Data From the CANVAS and CREDENCE Trials. J Am Heart Assoc. 2023 Jul 4;12(13):e028516. doi: 10.1161/JAHA.122.028516. Epub 2023 Jun 22.
Ferrannini G, Pollock C, Natali A, Yavin Y, Mahaffey KW, Ferrannini E. Extremes of both weight gain and weight loss are associated with increased incidence of heart failure and cardiovascular death: evidence from the CANVAS Program and CREDENCE. Cardiovasc Diabetol. 2023 Apr 29;22(1):100. doi: 10.1186/s12933-023-01832-5.
van der Hoek S, Jongs N, Oshima M, Neuen BL, Stevens J, Perkovic V, Levin A, Mahaffey KW, Pollock C, Greene T, Wheeler DC, Jardine MJ, Heerspink HJL. Glycemic Control and Effects of Canagliflozin in Reducing Albuminuria and eGFR: A Post Hoc Analysis of the CREDENCE Trial. Clin J Am Soc Nephrol. 2023 Jun 1;18(6):748-758. doi: 10.2215/CJN.0000000000000161. Epub 2023 Mar 31.
Yi TW, Smyth B, Di Tanna GL, Arnott C, Cardoza K, Kang A, Pollock C, Agarwal R, Bakris G, Charytan DM, de Zeeuw D, Heerspink HJL, Neal B, Wheeler DC, Cannon CP, Zhang H, Zinman B, Perkovic V, Levin A, Mahaffey KW, Jardine M; CREDENCE Trial Investigators. Kidney and Cardiovascular Effects of Canagliflozin According to Age and Sex: A Post Hoc Analysis of the CREDENCE Randomized Clinical Trial. Am J Kidney Dis. 2023 Jul;82(1):84-96.e1. doi: 10.1053/j.ajkd.2022.12.015. Epub 2023 Mar 7.
Sarraju A, Bakris G, Cannon CP, Cherney D, Damaraju CV, Figtree GA, Gogate J, Greene T, Heerspink HJL, Januzzi JL Jr, Neal B, Jardine MJ, Blais J, Kosiborod M, Levin A, Lingvay I, Weir MR, Perkovic V, Mahaffey KW. Cardiovascular Effects of Canagliflozin in Relation to Renal Function and Albuminuria. J Am Coll Cardiol. 2022 Nov 1;80(18):1721-1731. doi: 10.1016/j.jacc.2022.08.772.
Nunes JC, Yu J, Arnott C, Jardine MJ, Perkovic V, Mahaffey KW. Canagliflozin, mental health adverse events and diabetes: Exploratory analysis of the CREDENCE trial and CANVAS Program. Diabetes Obes Metab. 2022 Dec;24(12):2459-2464. doi: 10.1111/dom.14832. Epub 2022 Aug 19. No abstract available.
Li JW, Arnott C, Heerspink HJL, MBiostat QL, Cannon CP, Wheeler DC, Charytan DM, Barraclough J, Figtree GA, Agarwal R, Bakris G, de Zeeuw D, Greene T, Levin A, Pollock C, Zhang H, Zinman B, Mahaffey KW, Perkovic V, Neal B, Jardine MJ. Effect of Canagliflozin on Total Cardiovascular Burden in Patients With Diabetes and Chronic Kidney Disease: A Post Hoc Analysis From the CREDENCE Trial. J Am Heart Assoc. 2022 Aug 16;11(16):e025045. doi: 10.1161/JAHA.121.025045. Epub 2022 Aug 5.
Charytan DM, Yu J, Jardine MJ, Cannon CP, Agarwal R, Bakris G, Greene T, Levin A, Pollock C, Powe NR, Arnott C, Mahaffey KW; CREDENCE study investigators. Potential Effects of Elimination of the Black Race Coefficient in eGFR Calculations in the CREDENCE Trial. Clin J Am Soc Nephrol. 2022 Mar;17(3):361-373. doi: 10.2215/CJN.08980621. Epub 2022 Jan 21.
Heerspink HJL, Oshima M, Zhang H, Li J, Agarwal R, Capuano G, Charytan DM, Craig J, de Zeeuw D, Di Tanna GL, Levin A, Neal B, Perkovic V, Wheeler DC, Yavin Y, Jardine MJ. Canagliflozin and Kidney-Related Adverse Events in Type 2 Diabetes and CKD: Findings From the Randomized CREDENCE Trial. Am J Kidney Dis. 2022 Feb;79(2):244-256.e1. doi: 10.1053/j.ajkd.2021.05.005. Epub 2021 May 23.
Zhou Z, Jardine MJ, Li Q, Neuen BL, Cannon CP, de Zeeuw D, Edwards R, Levin A, Mahaffey KW, Perkovic V, Neal B, Lindley RI; CREDENCE Trial Investigators*. Effect of SGLT2 Inhibitors on Stroke and Atrial Fibrillation in Diabetic Kidney Disease: Results From the CREDENCE Trial and Meta-Analysis. Stroke. 2021 May;52(5):1545-1556. doi: 10.1161/STROKEAHA.120.031623. Epub 2021 Apr 20.
Yu J, Li J, Leaver PJ, Arnott C, Huffman MD, Udell JA, Perkovic V, Mahaffey KW, de Zeeuw D, Fulcher G, Matthews DR, Shaw W, Rosenthal N, Neal B, Figtree GA. Effects of canagliflozin on myocardial infarction: a post hoc analysis of the CANVAS programme and CREDENCE trial. Cardiovasc Res. 2022 Mar 16;118(4):1103-1114. doi: 10.1093/cvr/cvab128.
Jardine M, Zhou Z, Lambers Heerspink HJ, Hockham C, Li Q, Agarwal R, Bakris GL, Cannon CP, Charytan DM, Greene T, Levin A, Li JW, Neuen BL, Neal B, Oh R, Oshima M, Pollock C, Wheeler DC, de Zeeuw D, Zhang H, Zinman B, Mahaffey KW, Perkovic V. Kidney, Cardiovascular, and Safety Outcomes of Canagliflozin according to Baseline Albuminuria: A CREDENCE Secondary Analysis. Clin J Am Soc Nephrol. 2021 Mar 8;16(3):384-395. doi: 10.2215/CJN.15260920. Epub 2021 Feb 22.
Ye N, Jardine MJ, Oshima M, Hockham C, Heerspink HJL, Agarwal R, Bakris G, Schutte AE, Arnott C, Chang TI, Gorriz JL, Cannon CP, Charytan DM, de Zeeuw D, Levin A, Mahaffey KW, Neal B, Pollock C, Wheeler DC, Luca Di Tanna G, Cheng H, Perkovic V, Neuen BL. Blood Pressure Effects of Canagliflozin and Clinical Outcomes in Type 2 Diabetes and Chronic Kidney Disease: Insights From the CREDENCE Trial. Circulation. 2021 May 4;143(18):1735-1749. doi: 10.1161/CIRCULATIONAHA.120.048740. Epub 2021 Feb 8.
Sarraju A, Li J, Cannon CP, Chang TI, Agarwal R, Bakris G, Charytan DM, de Zeeuw D, Greene T, Heerspink HJL, Levin A, Neal B, Pollock C, Wheeler DC, Yavin Y, Zhang H, Zinman B, Perkovic V, Jardine M, Mahaffey KW. Effects of canagliflozin on cardiovascular, renal, and safety outcomes in participants with type 2 diabetes and chronic kidney disease according to history of heart failure: Results from the CREDENCE trial. Am Heart J. 2021 Mar;233:141-148. doi: 10.1016/j.ahj.2020.12.008. Epub 2020 Dec 22.
Durkin M, Blais J. Linear Projection of Estimated Glomerular Filtration Rate Decline with Canagliflozin and Implications for Dialysis Utilization and Cost in Diabetic Nephropathy. Diabetes Ther. 2021 Feb;12(2):499-508. doi: 10.1007/s13300-020-00953-4. Epub 2020 Dec 18.
Willis M, Nilsson A, Kellerborg K, Ball P, Roe R, Traina S, Beale R, Newell I. Cost-Effectiveness of Canagliflozin Added to Standard of Care for Treating Diabetic Kidney Disease (DKD) in Patients with Type 2 Diabetes Mellitus (T2DM) in England: Estimates Using the CREDEM-DKD Model. Diabetes Ther. 2021 Jan;12(1):313-328. doi: 10.1007/s13300-020-00968-x. Epub 2020 Dec 2.
Willis M, Asseburg C, Slee A, Nilsson A, Neslusan C. Development and Internal Validation of a Discrete Event Simulation Model of Diabetic Kidney Disease Using CREDENCE Trial Data. Diabetes Ther. 2020 Nov;11(11):2657-2676. doi: 10.1007/s13300-020-00923-w. Epub 2020 Sep 15.
Jardine MJ, Zhou Z, Mahaffey KW, Oshima M, Agarwal R, Bakris G, Bajaj HS, Bull S, Cannon CP, Charytan DM, de Zeeuw D, Di Tanna GL, Greene T, Heerspink HJL, Levin A, Neal B, Pollock C, Qiu R, Sun T, Wheeler DC, Zhang H, Zinman B, Rosenthal N, Perkovic V; CREDENCE Study Investigators. Renal, Cardiovascular, and Safety Outcomes of Canagliflozin by Baseline Kidney Function: A Secondary Analysis of the CREDENCE Randomized Trial. J Am Soc Nephrol. 2020 May;31(5):1128-1139. doi: 10.1681/ASN.2019111168.
Cannon CP, Perkovic V, Agarwal R, Baldassarre J, Bakris G, Charytan DM, de Zeeuw D, Edwards R, Greene T, Heerspink HJL, Jardine MJ, Levin A, Li JW, Neal B, Pollock C, Wheeler DC, Zhang H, Zinman B, Mahaffey KW. Evaluating the Effects of Canagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes Mellitus and Chronic Kidney Disease According to Baseline HbA1c, Including Those With HbA1c <7%: Results From the CREDENCE Trial. Circulation. 2020 Feb 4;141(5):407-410. doi: 10.1161/CIRCULATIONAHA.119.044359. Epub 2019 Nov 11. No abstract available.
Mahaffey KW, Jardine MJ, Bompoint S, Cannon CP, Neal B, Heerspink HJL, Charytan DM, Edwards R, Agarwal R, Bakris G, Bull S, Capuano G, de Zeeuw D, Greene T, Levin A, Pollock C, Sun T, Wheeler DC, Yavin Y, Zhang H, Zinman B, Rosenthal N, Brenner BM, Perkovic V. Canagliflozin and Cardiovascular and Renal Outcomes in Type 2 Diabetes Mellitus and Chronic Kidney Disease in Primary and Secondary Cardiovascular Prevention Groups. Circulation. 2019 Aug 27;140(9):739-750. doi: 10.1161/CIRCULATIONAHA.119.042007. Epub 2019 Jul 11.
Perkovic V, Jardine MJ, Neal B, Bompoint S, Heerspink HJL, Charytan DM, Edwards R, Agarwal R, Bakris G, Bull S, Cannon CP, Capuano G, Chu PL, de Zeeuw D, Greene T, Levin A, Pollock C, Wheeler DC, Yavin Y, Zhang H, Zinman B, Meininger G, Brenner BM, Mahaffey KW; CREDENCE Trial Investigators. Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy. N Engl J Med. 2019 Jun 13;380(24):2295-2306. doi: 10.1056/NEJMoa1811744. Epub 2019 Apr 14.
Jardine MJ, Mahaffey KW, Neal B, Agarwal R, Bakris GL, Brenner BM, Bull S, Cannon CP, Charytan DM, de Zeeuw D, Edwards R, Greene T, Heerspink HJL, Levin A, Pollock C, Wheeler DC, Xie J, Zhang H, Zinman B, Desai M, Perkovic V; CREDENCE study investigators. The Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) Study Rationale, Design, and Baseline Characteristics. Am J Nephrol. 2017 Dec 13;46(6):462-472. doi: 10.1159/000484633. Online ahead of print.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2013-004494-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
28431754DNE3001
Identifier Type: OTHER
Identifier Source: secondary_id
CR103517
Identifier Type: -
Identifier Source: org_study_id
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