CKDkb: a knowledge base and platform for drug development against non-alcoholic fatty liver disease

Clinical Trial Details

Trial ID:	L2674
Source ID:	NCT01032629
Associated Drug:	Placebo
Title:	CANVAS - CANagliflozin cardioVascular Assessment Study
Acronym:	CANVAS
Status:	COMPLETED
Study Results:	YES
Results:	https://ClinicalTrials.gov/show/NCT01032629/results
Conditions:	Diabetes Mellitus, Type 2\|Cardiovascular Diseases\|Risk Factors
Interventions:	DRUG: Placebo\|DRUG: Canagliflozin (JNJ-28431754) 100 mg\|DRUG: Canagliflozin (JNJ-28431754) 300 mg
Outcome Measures:	Primary: Major Adverse Cardiovascular Events (MACE) Composite of Cardiovascular (CV) Death, Non-Fatal Myocardial Infarction (MI), and Non-Fatal Stroke, MACE, defined as a composite of CV death, non-fatal MI, and nonfatal stroke. 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 MACE are presented., Up to approximately 8 years \| Secondary: Change From Baseline in Homeostasis Model Assessment 2 Steady-State Beta-Cell Function (HOMA2-%B) at the End-of-Treatment (EOT), The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-%B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). The normal reference population was set at 100 percent., Baseline and end of treatment (approximately 338 weeks)\|Percentage of Participants With Progression of Albuminuria at the End-of-Treatment, Progression defined as the development of micro-albuminuria (albumin/creatinine ratio (ACR) greater than or equal to \[\>=\] 30 milligram per gram (mg/g) and less than or equal to \<= 300 mg/g) or macroalbuminuria (ACR of \>300 mg/g) in a participant with baseline normoalbuminuria or the development of macro-albuminuria in a participant with baseline microalbuminuria. Percentage of participants with progression of albuminuria at the end-of-treatment were assessed., End of treatment (approximately 338 weeks)\|Change From Baseline in Proinsulin/Insulin (PI/I) Ratio at the End-of-Treatment, A raised proinsulin-to-insulin ratio due to impaired processing of proinsulin is an early marker of beta cell dysfunction. Beta-cell dysfunction was evaluated by calculating the PI/I ratio, which estimates the capacity of beta cells to convert proinsulin to insulin and may represent an acceptable method to indicate the degree of beta-cell secretion., Baseline and end of treatment (approximately 338 weeks)\|Change From Baseline in Urinary Albumin/Creatinine Ratio at End-of-Treatment, Urinary Albumin/Creatinine Ratio is a potential marker of chronic kidney disease, calculated as a ratio of Urinary Albumin and Urinary Creatinine., Baseline and End of treatment (approximately 338 weeks)\|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at End-of-Treatment, Change from baseline in Estimated Glomerular Filtration Rate (eGFR) was assessed at end of treatment. GFR is a measure of the rate at which blood is filtered by the kidney. Modification of Diet in Renal Disease (MDRD) is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and sex. eGFR milliliters/minute/1.73 meters square (mL/min/1.73 m\^2) = 175 \* (serum creatinine) \^ 1.154 \* (Age) \^-0.203 \(0.742 if female) \ (1.21 if Black)., Baseline and end of treatment (approximately 338 weeks)\|Change From Baseline in Glycated Hemoglobin (HbA1c) at End-of-Treatment, Change from baseline in glycated hemoglobin (HbA1c) percentage (%) was assessed at end of treatment. Glycated hemoglobin is a form of hemoglobin that is measured primarily to identify the average glucose concentration in the blood., Baseline and end of treatment (approximately 338 weeks)\|Change From Baseline in Fasting Plasma Glucose (FPG) Levels at End-of-Treatment, Change from baseline in the fasting plasma glucose levels at end-of-treatment was assessed., Baseline and end of treatment (approximately 338 weeks)\|Percent Change From Baseline in Body Weight at End-of-Treatment, Percent change from baseline in body weight was assessed at the end of treatment., Baseline and end of treatment (approximately 338 weeks)\|Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at End-of-Treatment, Change from baseline in systolic blood pressure and diastolic blood pressure was assessed., Baseline and end of treatment (approximately 338 weeks)\|Change From Baseline in Triglycerides Levels at End-of-Treatment, Change from baseline in triglycerides levels was assessed., Baseline and end of treatment (approximately 338 weeks)\|Change From Baseline in Cholesterol, High-Density Lipoprotein Cholesterol (HDL-C) and Low Density Lipoprotein Cholesterol (LDL-C) Levels at End-of-Treatment, Change from baseline in cholesterol, high-density lipoprotein cholesterol and low density lipoprotein cholesterol levels were assessed., Baseline and end of treatment (approximately 338 weeks)\|Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) to High-Density Lipoprotein-Cholesterol (HDL-C) Ratio at End-of-Treatment, Change from baseline in LDL-C to HDL-C ratio was assessed., Baseline and end of treatment (approximately 338 weeks)
Sponsor/Collaborators:	Sponsor: Janssen Research & Development, LLC \| Collaborators: The George Institute for Global Health, Australia
Gender:	ALL
Age:	ADULT, OLDER_ADULT
Phases:	PHASE3
Enrollment:	4330
Study Type:	INTERVENTIONAL
Study Designs:	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)\|Primary Purpose: TREATMENT
Start Date:	2009-12-09
Completion Date:	2017-02-22
Results First Posted:	2018-12-07
Last Update Posted:	2018-12-07
Locations:	Birmingham, Alabama, United States\|Mesa, Arizona, United States\|Tucson, Arizona, United States\|La Mesa, California, United States\|Los Gatos, California, United States\|Pismo Beach, California, United States\|Stockton, California, United States\|Walnut Creek, California, United States\|Doral, Florida, United States\|Fort Lauderdale, Florida, United States\|Jacksonville, Florida, United States\|Miami, Florida, United States\|Plantation, Florida, United States\|Atlanta, Georgia, United States\|Duluth, Georgia, United States\|Boise, Idaho, United States\|Eagle, Idaho, United States\|Meridian, Idaho, United States\|Peoria, Illinois, United States\|Topeka, Kansas, United States\|Crestview Hills, Kentucky, United States\|Lexington, Kentucky, United States\|Auburn, Maine, United States\|Scarborough, Maine, United States\|Oxon Hill, Maryland, United States\|Royal Oak, Michigan, United States\|Kansas City, Missouri, United States\|Saint Louis, Missouri, United States\|Omaha, Nebraska, United States\|Camden, New Jersey, United States\|Bronx, New York, United States\|Flushing, New York, United States\|Chapel Hill, North Carolina, United States\|Charlotte, North Carolina, United States\|Cincinnati, Ohio, United States\|Cleveland, Ohio, United States\|Columbus, Ohio, United States\|Gallipolis, Ohio, United States\|Mentor, Ohio, United States\|Toledo, Ohio, United States\|Beaver, Pennsylvania, United States\|Norristown, Pennsylvania, United States\|Sayre, Pennsylvania, United States\|Greenville, South Carolina, United States\|Kingsport, Tennessee, United States\|Dallas, Texas, United States\|Houston, Texas, United States\|Odessa, Texas, United States\|San Antonio, Texas, United States\|Temple, Texas, United States\|Draper, Utah, United States\|Salt Lake City, Utah, United States\|Sandy, Utah, United States\|West Jordan, Utah, United States\|Danville, Virginia, United States\|Richmond, Virginia, United States\|Spokane, Washington, United States\|Tacoma, Washington, United States\|Buenos Aires, Argentina\|Capital Federal, Argentina\|Ciudad Autonma Buenos Aires, Argentina\|Ciudad Autonoma De Buenos Aires, Argentina\|Cordoba, Argentina\|Corrientes, Argentina\|Godoy Cruz, Argentina\|Mar Del Plata, Argentina\|Rosario, Argentina\|Santa Fe, Argentina\|Auchenflower, Australia\|Box Hill, Australia\|Caboolture, Australia\|Caringbah, Australia\|Clayton, Australia\|Daw Park, Australia\|East Ringwood, Australia\|Elizabeth Vale, Australia\|Hornsby, Nsw 2077, Australia\|Kippa Ring, Australia\|Launceston, Australia\|Liverpool, Australia\|Melbourne, Australia\|Milton, Australia\|Parkville, Australia\|Reservoir, Australia\|Sherwood, Australia\|Southport, Australia\|St Leonards, Australia\|West Heidelberg, Australia\|Wollongong, Australia\|Woolloongabba, Australia\|Arlon, Belgium\|Bonheiden, Belgium\|Brussel, Belgium\|Edegem, Belgium\|Genk, Belgium\|Leuven, Belgium\|Calgary, Alberta, Canada\|Coquitlam, British Columbia, Canada\|Winnipeg, Manitoba, Canada\|St. John'S, Newfoundland and Labrador, Canada\|Brampton, Ontario, Canada\|London, Ontario, Canada\|Mississauga, Ontario, Canada\|Nemarket, Ontario, Canada\|Sarnia, Ontario, Canada\|Sudbury, Ontario, Canada\|Toronto, Ontario, Canada\|Laval, Quebec, Canada\|Lévis, Quebec, Canada\|Montreal, Quebec, Canada\|Val-Belair, Quebec, Canada\|Saskatoon, Saskatchewan, Canada\|Bogota, Colombia\|Floridablanca, Colombia\|Kralupy Nad Vltavou, Czechia\|Moravsky Krumlov, Czechia\|Olomouc 9, Czechia\|Ostrava, Czechia\|Pisek, Czechia\|Prague 5, Czechia\|Praha 11, Czechia\|Praha 8, Czechia\|Praha, Czechia\|Znojmo N/A, Czechia\|Pärnu, Estonia\|Tallinn, Estonia\|Tartu, Estonia\|Viljandi, Estonia\|Amiens, France\|Nimes Cedex 9, France\|Pessac, France\|Berlin, Germany\|Dortmund, Germany\|Dresden, Germany\|Hamburg, Germany\|Künzing, Germany\|Mainz, Germany\|Münster, Germany\|Pirna, Germany\|Saarlouis, Germany\|Speyer, Germany\|Villingen-Schwenningen, Germany\|Budapest, Hungary\|Kecskemet, Hungary\|Mosonmagyaróvár, Hungary\|Zalaegerszeg, Hungary\|Ahemadabad, India\|Ahmedabad, India\|Ambawadi, India\|Bangalore, Karnataka, India\|Bangalore, India\|Belgaum, India\|Calicut, India\|Chennai, India\|Cochin, India\|Coimbatore, India\|Ernakulam, India\|Ghaziabad, India\|Hyderabad, India\|Indore, India\|Jaipur, India\|Karnal, India\|Kerala, India\|Kochi, India\|Kolkata, India\|Lucknow, India\|Mangalore, India\|Mumbai, India\|Mysore, India\|Nagpur, India\|New Delhi, India\|Patna, India\|Pune, India\|Rajkot, India\|Trivandrum, Kerala, India\|Vadodhara, India\|Vijayawada, India\|Visakhapatnam, India\|Beer Sheba, Israel\|Holon, Israel\|Jerusalem, Israel\|Kfar Saba, Israel\|Luxembourg, Luxembourg\|Georgetown, Malaysia\|Johor Bahru, Malaysia\|Kota Bharu, Malaysia\|Kuala Lumpur N/A, Malaysia\|Petaling Jaya, Malaysia\|Pulau Pinang, Malaysia\|Subang Jaya, Malaysia\|Aguascalientes, Mexico\|Celaya, Mexico\|Ciudad De Mexico, Mexico\|Durango, Mexico\|Guadalajara, Mexico\|Monterrey, Mexico\|Almelo, Netherlands\|Almere, Netherlands\|Amsterdam, Netherlands\|Arnhem, Netherlands\|Delft, Netherlands\|Den Helder, Netherlands\|Dordrecht, Netherlands\|Eindhoven, Netherlands\|Groningen, Netherlands\|Hoorn Nh, Netherlands\|Rotterdam, Netherlands\|Tilburg, Netherlands\|Utrecht, Netherlands\|Velp Gld, Netherlands\|Zoetermeer, Netherlands\|Zwijndrecht, Netherlands\|Auckland, New Zealand\|Christchurch, New Zealand\|Dunedin, New Zealand\|Tauranga, New Zealand\|Wellington, New Zealand\|Alesund, Norway\|Asker, Norway\|Bekkestua, Norway\|Elverum, Norway\|Hamar, Norway\|Lierskogen, Norway\|Moss, Norway\|Oslo, Norway\|Skedsmokorset, Norway\|Bialystok, Poland\|Ciechocinek, Poland\|Gniewkowo, Poland\|Grudziadz, Poland\|Katowice, Poland\|Krakow, Poland\|Lublin, Poland\|Plock, Poland\|Poznan, Poland\|Rzeszow, Poland\|Slawkow, Poland\|Torun, Poland\|Warszawa, Poland\|Wroclaw, Poland\|Arkhangelsk, Russian Federation\|Chelyabinsk, Russian Federation\|Ekaterinburg, Russian Federation\|Kemerovo, Russian Federation\|Kirov, Russian Federation\|Kursk, Russian Federation\|Moscow N/A, Russian Federation\|Moscow, Russian Federation\|Nizhny Novgorod, Russian Federation\|Novosibirsk, Russian Federation\|Omsk, Russian Federation\|Penza, Russian Federation\|Rostov-On-Don, Russian Federation\|Russia, Russian Federation\|Ryazan, Russian Federation\|Saint Petersburg, Russian Federation\|Saint-Petersburg, Russian Federation\|Saratov, Russian Federation\|Smolensk, Russian Federation\|St Petersburg, Russian Federation\|Tomsk, Russian Federation\|Tula, Russian Federation\|Tyumen, Russian Federation\|Yaroslavl Nap, Russian Federation\|Yaroslavl, Russian Federation\|Alicante, Spain\|Almeria, Spain\|Barcelona, Spain\|Figueres, Spain\|Madrid, Spain\|Málaga, Spain\|Oviedo, Spain\|Reus, Spain\|Sabadell, Spain\|San Juan De Alicante, Spain\|Santiago De Compostela, Spain\|Sevilla N/A, Spain\|Valencia, Spain\|Viladecans, Spain\|Borås, Sweden\|Göteborg, Sweden\|Helsingborg, Sweden\|Lund, Sweden\|Malmö, Sweden\|Oskarshamn N/A, Sweden\|Piteå, Sweden\|Stockholm, Sweden\|Uddevalla, Sweden\|Dnepropetrovsk, Ukraine\|Donetsk, Ukraine\|Kharkov, Ukraine\|Kiev, Ukraine\|Kyiv, Ukraine\|Odessa, Ukraine\|Ternopol, Ukraine\|Uzhgorod, Ukraine\|Vinnitsa, Ukraine\|Zaporozhye, Ukraine\|Belfast, United Kingdom\|Blackburn, United Kingdom\|Bolton, United Kingdom\|Chorley, United Kingdom\|Derby, United Kingdom\|Glasgow, United Kingdom\|Hull, United Kingdom\|Leicester, United Kingdom\|Liverpool, United Kingdom\|Londonderry, United Kingdom\|London, United Kingdom\|Manchester, United Kingdom\|Randalstown, United Kingdom\|Salford, United Kingdom\|York, United Kingdom
URL:	https://clinicaltrials.gov/show/NCT01032629

Knowledge Graph
Associated Data

Drug ID	Drug Name	Type	DrugBank ID	Targets	Category	Latest Progress

Clinical Trial Details

Summary

Knowledge Graph

Associated Data

Associated NAFLD Drugs (0)