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Clinical Trial Details

Trial ID: L7174
Source ID: NCT01989754
Associated Drug: Placebo
Title: A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus
Acronym: CANVAS-R
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01989754/results
Conditions: Diabetes Mellitus, Type 2|Albuminuria
Interventions: DRUG: Placebo|DRUG: Canagliflozin, 100 mg|DRUG: Canagliflozin, 300 mg
Outcome Measures: Primary: Progression of Albuminuria, Progression defined as the development of micro-albuminuria (Urine Albumin Creatinine Ratio \[UACR\] 30 to 300 milligram per gram \[mg/g\]) or macroalbuminuria (Albumin/creatinine ratio \[ACR\] of greater than \[\>\] 300 mg/g) in a participant with baseline normoalbuminuria (ACR less than \[\<\] 30 mg/g) or the development of macro-albuminuria in a participant with baseline microalbuminuria with an ACR increase greater than or equal to (\>=) 30 percent from baseline. Participants with macroalbuminuria at baseline (ACR\>300 mg/g) were excluded from the analysis. Event rate was estimated based on the time to the first occurrence of the event., Up to 3 years | Secondary: Composite of Cardiovascular (CV) Death Events or Hospitalization for Heart Failure, Analyses were using adjudicated events, that is (i.e.) CV death events or hospitalization due to heart failure, and adjudication of these outcomes by the Endpoint Adjudication Committee (EAC) were done in a blinded fashion. Event rate was estimated based on the time to the first occurrence of the event., Approximately 3 years|Cardiovascular (CV) Death, Analyses were using adjudicated events, i.e. CV death events, and adjudication of these outcomes by the Endpoint Adjudication Committee (EAC) were done in a blinded fashion. Event rate was estimated based on the time to the first occurrence of the event., Approximately 3 years
Sponsor/Collaborators: Sponsor: Janssen Research & Development, LLC | Collaborators: The George Institute for Global Health, Australia
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 5813
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2014-01-16
Completion Date: 2017-02-23
Results First Posted: 2018-12-11
Last Update Posted: 2018-12-11
Locations: Little Rock, Arkansas, United States|Carmichael, California, United States|Concord, California, United States|Pismo Beach, California, United States|Roseville, California, United States|Thousand Oaks, California, United States|Denver, Colorado, United States|Hollywood, Florida, United States|Jacksonville, Florida, United States|Miami, Florida, United States|New Port Richey, Florida, United States|Opa-locka, Florida, United States|Orlando, Florida, United States|Palm Harbor, Florida, United States|Tampa, Florida, United States|Meridian, Idaho, United States|Chicago, Illinois, United States|Valparaiso, Indiana, United States|Topeka, Kansas, United States|Louisville, Kentucky, United States|Mandeville, Louisiana, United States|Metairie, Louisiana, United States|Elkridge, Maryland, United States|Flint, Michigan, United States|Picayune, Mississippi, United States|Kansas City, Missouri, United States|Saint Louis, Missouri, United States|Washington, Missouri, United States|Omaha, Nebraska, United States|Las Vegas, Nevada, United States|Cornelius, North Carolina, United States|Hickory, North Carolina, United States|Mooresville, North Carolina, United States|Canal Fulton, Ohio, United States|Franklin, Ohio, United States|Mason, Ohio, United States|Oklahoma City, Oklahoma, United States|Beaver, Pennsylvania, United States|Levittown, Pennsylvania, United States|Norristown, Pennsylvania, United States|Pittsburgh, Pennsylvania, United States|Tipton, Pennsylvania, United States|Greer, South Carolina, United States|Jefferson City, Tennessee, United States|Austin, Texas, United States|Pearland, Texas, United States|Bountiful, Utah, United States|Draper, Utah, United States|Salt Lake City, Utah, United States|West Jordan, Utah, United States|South Burlington, Vermont, United States|Falls Church, Virginia, United States|Norfolk, Virginia, United States|Virginia Beach, Virginia, United States|Spokane, Washington, United States|Milwaukee, Wisconsin, United States|Wauwatosa, Wisconsin, United States|Buenos Aires, Argentina|Ciudad Autonoma De Buenos Aires, Argentina|Ciudad De Buenos Aires, Argentina|Cordoba, Argentina|Mar Del Plata, Argentina|Moron, Argentina|Rosario, Argentina|Zarate, Buenos Aires, Argentina|Box Hill, Australia|Cairns, Australia|Daw Park, Australia|Freemantle, Australia|Liverpool, Australia|Melbourne, Australia|Newcastle, Australia|Sherwood, Australia|Sydney, Australia|Tasmania, Australia|Woden, Australia|Woolloongabba, Australia|Bonheiden, Belgium|Brugge, Belgium|Edegem, Belgium|Gent, Belgium|La Louvière, Belgium|Leuven, Belgium|Liege, Belgium|Liÿge, Belgium|Merksem, Belgium|Ransart, Belgium|Roeselare, Belgium|Tessenderlo, Belgium|Belem, Brazil|Belo Horizonte, Brazil|Campinas, Brazil|Caxias Do Sul, Brazil|Curitiba, Brazil|Fortaleza, Brazil|Mogi Das Cruzes, Brazil|Passo Fundo, Brazil|Porto Alegre, Brazil|Rio De Janeiro, Brazil|Sao Paulo, Brazil|São José Do Rio Preto, Brazil|São Paulo, Brazil|Coquitlam, British Columbia, Canada|Winnipeg, Manitoba, Canada|Halifax, Nova Scotia, Canada|Guelph, Ontario, Canada|Mississauga, Ontario, Canada|Oshawa, Ontario, Canada|Sarnia, Ontario, Canada|Thornhill, Ontario, Canada|Toronto, Ontario, Canada|Laval, Quebec, Canada|Lévis, Quebec, Canada|Quebec City, Quebec, Canada|Saint Marc Des Carriéres, Quebec, Canada|Sherbrooke, Quebec, Canada|Westmont, Quebec, Canada|Saskatoon, Saskatchewan, Canada|Baotou, China|Beijing, China|Hangzhou, China|Jinan, China|Shenyang, China|Wuxi, China|Beroun, Czechia|Ostrava, Czechia|Plzen, Czechia|Praha 10, Czechia|Praha 1, Czechia|Praha 4, Czechia|Praha 8, Czechia|Znojmo, Czechia|Amiens, France|Bois Guillaume, France|Bordeaux, France|Dijon, France|Grenoble, France|La Rochelle Cedex 1, France|Le Creusot, France|Narbonne Cedex, France|Paris, France|Poitiers, France|Aschaffenburg, Germany|Aßlar, Germany|Bad Oeynhausen, Germany|Dortmund, Germany|Dresden, Germany|Freiburg, Germany|Hannover, Germany|Kassel, Germany|Mainz, Germany|Neuwied, Germany|Saarbrücken, Germany|Villingen-Schwenningen, Germany|Balatonfured, Hungary|Budapest, Hungary|Dunaújváros, Hungary|Eger, Hungary|Kecskemét, Hungary|Nagykanizsa, Hungary|Pecs, Hungary|Szekesfehervar, Hungary|Szikszó, Hungary|Szombathely, Hungary|Zalaegerszeg, Hungary|*Osenza*, Italy|Arenzano, Italy|Bologna, Italy|Catanzaro, Italy|Chieri (Torino), Italy|Firenze, Italy|Messina, Italy|Milano, Italy|Napoli, Italy|Ravenna, Italy|Roma N/A, Italy|Roma, Italy|Sesto San Giovanni (Milano), Italy|Verona, Italy|Ansan, Korea, Republic of|Bucheon, Korea, Republic of|Busan, Korea, Republic of|Changwon, Korea, Republic of|Cheongju, Korea, Republic of|Daegu, Korea, Republic of|Gyeonggi-Do, Korea, Republic of|Iksan, Korea, Republic of|Incheon, Korea, Republic of|Jeonju, Korea, Republic of|Seongnam-Si, Korea, Republic of|Seoul, Korea, Republic of|Suwon, Korea, Republic of|Ulsan, Korea, Republic of|Wonju-Si, Korea, Republic of|Batu Caves, Malaysia|Georgetown, Malaysia|Ipoh, Malaysia|Kelantan, Malaysia|Kota Bharu, Malaysia|Kuala Lumpur, Malaysia|Kuching, Malaysia|Aguascalientes, Mexico|Celaya, Mexico|Cuernavaca, Mexico|Culiacan, Mexico|Guadalajara, Mexico|Mexico, Mexico|Pachuca De Soto, Mexico|Queretaro, Mexico|San Luis Potosi, Mexico|Tampico, Mexico|Almelo, Netherlands|Almere, Netherlands|Amersfoort, Netherlands|Amsterdam, Netherlands|Dordrecht, Netherlands|Eindhoven, Netherlands|Groningen, Netherlands|Hardenberg, Netherlands|Hoogeveen, Netherlands|Hoogezand, Netherlands|Kloosterhaar, Netherlands|Leiden, Netherlands|Meppel, Netherlands|Poortvliet, Netherlands|Rotterdam, Netherlands|Utrecht, Netherlands|Velp, Netherlands|Waalwijk, Netherlands|Wamel, Netherlands|Zoetermeer, Netherlands|Zwijndrecht, Netherlands|Auckland, New Zealand|Christchurch, New Zealand|Newtown, New Zealand|Palmerston North, New Zealand|Rotorua, New Zealand|Tauranga, New Zealand|Wellington, New Zealand|Bialystok, Poland|Bydgoszcz, Poland|Chrzanow, Poland|Gdansk, Poland|Grodzisk Mazowiecki, Poland|Katowice, Poland|Krakow, Poland|Lublin, Poland|Oswiecim, Poland|Torun, Poland|Tychy, Poland|Warszawa, Poland|Wroclaw, Poland|Ponce Pr, Puerto Rico|Trujillo Alto, Puerto Rico|Arkhangelsk, Russian Federation|Barnaul, Russian Federation|Chelyabinsk, Russian Federation|Kemerovo, Russian Federation|Nizhny Novgorod, Russian Federation|Penza, Russian Federation|Rostov-On-Don, Russian Federation|Saint Petersburg, Russian Federation|Saint-Petersburg, Russian Federation|Samara, Russian Federation|Saratov, Russian Federation|Smolensk, Russian Federation|St Petersburg, Russian Federation|St-Petersburg, Russian Federation|Syktyvkar, Russian Federation|Tyumen, Russian Federation|Vsevolzhsk, Russian Federation|Yaroslavl, Russian Federation|A Coruna, Spain|Alcalá De Henares, Spain|Alicante, Spain|Almeria, Spain|Alzira, Spain|Barcelona, Spain|Ciudad Real, Spain|Cordoba, Spain|Ferrol, Spain|Figueres, Spain|Galdakao, Spain|Madrid, Spain|Malaga, Spain|Móstoles, Spain|Palma De Mallorca, Spain|Sabadell, Spain|San Sebastian De Los Reyes, Spain|Sant Joan D'Alacant, Spain|Santa Cruz De Tenerife, Spain|Santiago De Compostela, Spain|Segovia, Spain|Sevilla N/A, Spain|Sevilla, Spain|Valencia, Spain|Viladecans, Spain|Borås, Sweden|Goteborg, Sweden|Helsingborg, Sweden|Karlstad, Sweden|Linköping, Sweden|Lund, Sweden|Malmo, Sweden|Stockholm, Sweden|Uddevalla, Sweden|Uppsala, Sweden|Vallingby, Sweden|Västra Frölunda, Sweden|Kaohsiung County, Taiwan|Taichung, Taiwan|Tainan, Taiwan|Taipei, Taiwan|Tiachung, Taiwan|Xindian, Taiwan|Cherkasy, Ukraine|Chernivtsy, Ukraine|Dnipropetrovsk, Ukraine|Ivan-Frankivsk, Ukraine|Ivano-Frankovsk, Ukraine|Kharkiv, Ukraine|Kharkov, Ukraine|Kiev, Ukraine|Kyiv, Ukraine|Lviv, Ukraine|Odesa, Ukraine|Odessa, Ukraine|Poltava, Ukraine|Sumy, Ukraine|Ternopil, Ukraine|Uzhgorod, Ukraine|Vinnitsa, Ukraine|Vinnytsya, Ukraine|Zaporizhzhia, Ukraine|Zaporizhzhya, Ukraine|Addlestone, United Kingdom|Belfast, United Kingdom|Birmingham, United Kingdom|Blackburn, United Kingdom|Bristol, United Kingdom|Bury St Edmunds, United Kingdom|Chesterfield, United Kingdom|Derby, United Kingdom|Doncaster, United Kingdom|Ipswich, United Kingdom|Leicester, United Kingdom|Liverpool, United Kingdom|Manchester, United Kingdom|Salford, United Kingdom|Taunton, United Kingdom|Torquay, United Kingdom|Truro, United Kingdom|Wellingborough, United Kingdom|Welwyn Garden City, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01989754