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

December 4, 2019 updated by: Janssen Research & Development, LLC

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

4401

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Bahia Blanca, Argentina
      • Buenos Aires, Argentina
      • Ciudad Autonoma Buenos Aires, Argentina
      • Cordoba, Argentina
      • Corrientes, Argentina
      • Córdoba, Argentina
      • Godoy Cruz, Argentina
      • Junin, Argentina
      • La Plata, Argentina
      • La Plata Lpl Lpl, Argentina
      • Mar del Plata, Argentina
      • Mendoza, Argentina
      • Moron, Argentina
      • Munro, Argentina
      • Parana, Argentina
      • Quilmes, Argentina
      • Ramos Mejia, Argentina
      • Rosario, Argentina
      • Salta, Argentina
      • San Luis, Argentina
      • San Martin, Argentina
      • San Migeul De Tucuman, Argentina
      • San Miguel de Tucuman, Argentina
      • San Nicolas, Argentina
      • Santa Fe, Argentina
      • Sarandi, Argentina
      • Tapiales, Argentina
      • Temperley, Argentina
      • Villa Maria, Argentina
      • Zarate, Buenos Aires, Argentina
  • Australia
      • 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
  • Brazil
      • Aparecida de Goiânia, Brazil
      • Belo Horizonte, Brazil
      • Belém, Brazil
      • Botucatu, Brazil
      • Brasilia, 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
      • Passo Fundo, Brazil
      • Porto Alegre, Brazil
      • Rio de Janeiro, Brazil
      • Santo Andre, Brazil
      • Santo André, Brazil
      • Sao Jose Do Rio Preto, Brazil
      • Sao Paulo, Brazil
      • São José dos Campos, Brazil
      • São Paulo, Brazil
      • Tatuí, Brazil
  • Bulgaria
      • Blagoevgrad, Bulgaria
      • Byala, Bulgaria
      • Gulyantsi, Bulgaria
      • Pazardzhik, Bulgaria
      • Pleven, Bulgaria
      • Plovdiv, Bulgaria
      • Sofia, Bulgaria
      • Varna, Bulgaria
  • Canada
      • Quebec, Canada
      • Québec, Canada
      • Toronto, Canada
      • Vancouver, Canada
    • Alberta
      • Edmonton, Alberta, Canada
    • British Columbia
      • New Westminster, British Columbia, Canada
      • Vancouver, British Columbia, Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • Ontario
      • Brampton, Ontario, Canada
      • London, Ontario, Canada
      • NewMarket, Ontario, Canada
      • Oshawa, Ontario, Canada
      • Smiths Falls, Ontario, Canada
      • Thornhill, Ontario, Canada
      • Toronto, Ontario, Canada
      • Weston, Ontario, Canada
    • Quebec
      • Greenfield Park, Quebec, Canada
      • Montreal, Quebec, Canada
      • Québec, Quebec, Canada
  • Chile
      • Concepcion, Chile
      • Santiago, Chile
      • Temuco, Chile
  • China
      • Beijing, China
      • Changchun, China
      • Changde, China
      • Changsha, China
      • Chengdu, China
      • Chenzhou, China
      • Dalian, China
      • Foshan, China
      • Guangzhou, China
      • Huai'an, China
      • Nanchang, China
      • Nanjing, China
      • Shanghai, China
      • Shenyang, China
      • Wuhan, China
      • Wulumuqi, China
      • Xian, China
  • Colombia
      • Barranquilla, Colombia
      • Bogota, Colombia
      • Bucaramanga, Colombia
      • Cali, Colombia
      • Floridablanca, Colombia
      • Manizales, Colombia
      • Medellin, Colombia
      • Pasto, Colombia
      • Pereira, Colombia
  • Czechia
      • Ceske Budejovice, Czechia
      • Cesky Krumlov, Czechia
      • Chocen, Czechia
      • Havlickuv Brod, Czechia
      • Hradec Kralove-Vekose, Czechia
      • Hradec Nad Svitavou, Czechia
      • Jindrichuv Hradec, Czechia
      • Olomouc, Czechia
      • Praha, Czechia
      • Praha 10, Czechia
      • Praha 2, Czechia
      • Praha 4, Czechia
      • Praha 5, Czechia
      • Slany, Czechia
      • Trutnov, Czechia
      • Uherske Hradiste, Czechia
      • Usti Nad Labem, Czechia
  • France
      • Besancon Cedex, France
      • Brest cedex, France
      • Colmar N/a, France
      • Corbeil Essonnes Cedex, France
      • Créteil Cedex, France
      • Grenoble, France
      • Lyon cedex 03, France
      • Marseille Cedex 05, France
      • Metz cedex 03, France
      • Nantes Cedex 01, France
      • Paris, France
      • Paris Cedex 15, France
      • Paris Cedex 18, France
      • Pierre-Bénit, France
      • Poitiers, France
      • St Priest-en-Jarez, France
      • Strasbourg, France
      • Toulouse Cedex 9, France
  • Germany
      • Bad Kreuznach - Bosenheim, Germany
      • Dietzenbach, Germany
      • Dresden, Germany
      • Essen, Germany
      • Hamburg, Germany
      • Hannover, Germany
      • Köln, Germany
      • Muenster, Germany
  • Guatemala
      • Guatemala, Guatemala
      • Guatemala City, Guatemala
  • Hungary
      • Baja, Hungary
      • Balatonfured, Hungary
      • Budapest, Hungary
      • Debrecen, Hungary
      • Eger, Hungary
      • Esztergom, Hungary
      • Godollo, Hungary
      • Gyula, Hungary
      • Hu-4012 Debrecen N/a, Hungary
      • Kaposvar, Hungary
      • Kecskemet N/a, Hungary
      • Komarom, Hungary
      • Nyiregyhaza, Hungary
      • Pecs, Hungary
      • Szeged N/a, Hungary
      • Szigetvar, Hungary
      • Veszprem, Hungary
      • Zalaegerszeg, Hungary
  • India
      • Calicut, India
      • Chennai, India
      • Delhi, India
      • Hyderabad, India
      • Kozhikode, India
      • Lucknow, India
      • Ludhiyana, India
      • Mangalore, India
      • Mumbai, India
      • Mysore, India
      • Secunderabad, India
      • Trivandrum, India
      • Vijayawada, India
      • Vishakhapatnam, India
  • Japan
      • Ageo-shi, Japan
      • Chiyoda-ku, Japan
      • Fukuoka, Japan
      • Hamamatsu-shi, Japan
      • Hamura-shi, Japan
      • Ina-shi, Japan
      • Izumisano, Japan
      • Kamakura-shi, Japan
      • Kanazawa, Japan
      • Kawanishi-shi, Japan
      • Koriyama-shi, Japan
      • Kuki-shi, Japan
      • Kyoto, Japan
      • Matsuyama-shi, Japan
      • Midori-shi, Japan
      • Minato-ku, Japan
      • Nagoya-shi, Japan
      • Osaka-shi, Japan
      • Ota-shi, Japan
      • Saiki-shi, Japan
      • Sashima-gun, Japan
      • Shinjuku-ku, Japan
      • Toyama-shi, Japan
      • Uwajima-shi, Japan
      • Yamanashi, Japan
      • Yokohama-City, Japan
      • Yokohama-shi, Japan
  • Korea, Republic of
      • Busan, Korea, Republic of
      • Daegu, Korea, Republic of
      • Incheon, Korea, Republic of
      • Seongnam, Korea, Republic of
      • Seoul, Korea, Republic of
  • Lithuania
      • Kaunas, Lithuania
      • Klaipeda, Lithuania
      • Siauliai, Lithuania
  • Malaysia
      • Batu Caves, Malaysia
      • Ipoh, Malaysia
      • Johor, Malaysia
      • Kuala Lumpur, Malaysia
      • Kuala Lumpur N/a, Malaysia
      • Kuantan, Malaysia
      • Melaka, Malaysia
      • Perai, Malaysia
      • Petaling Jaya, Malaysia
      • Seremban, Malaysia
      • Seri Manjung, Malaysia
      • Sungai Petani, Kedah, Malaysia
      • Tampin, Malaysia
      • Temerloh, Malaysia
  • Mexico
      • Aguascalientes, Mexico
      • Celaya, Mexico
      • Chihuahua, Mexico
      • Ciudad De Mexic, Mexico
      • Ciudad De Mexico, Mexico
      • Cuautitlan Izcalli, Mexico
      • Culiacan, Mexico
      • Culiacán, Mexico
      • Durango, Mexico
      • El Salto, Mexico
      • Guadalajara, Mexico
      • Leon, Mexico
      • Merida, Mexico
      • Mexico, Mexico
      • Mexico City, Mexico
      • Monterrey, Mexico
      • Morelia, Mexico
      • Orizaba, Mexico
      • Pachuca, Mexico
      • Pachuca de Soto, Mexico
      • Queretaro, Mexico
      • San Luis Potosi, Mexico
      • Tlalnepantla de Baz, Mexico
      • Veracruz, Mexico
      • Zapopan, Mexico
  • New Zealand
      • Auckland, New Zealand
      • Christchurch, New Zealand
      • Dunedin, New Zealand
      • Palmerston North, New Zealand
      • Rotorua, New Zealand
      • Takapuna Auckland, New Zealand
      • Tauranga, New Zealand
      • Wellington, New Zealand
  • Philippines
      • Cagayan De Oro City, Philippines
      • Cebu, Philippines
      • Cebuu City, Philippines
      • Davao City, Philippines
      • Iloilo City, Philippines
      • Lipa City, Philippines
      • Marikina City, Philippines
      • Pasay City, Philippines
      • Pasig, Philippines
      • Quezon City, Philippines
      • San Fernando, Philippines
      • Tagbilaran City, Philippines
      • Taytay, Philippines
  • Poland
      • Bydgoszcz, Poland
      • Chorzow, Poland
      • Katowice, Poland
      • Krakow, Poland
      • Lodz, Poland
      • Lublin, Poland
      • Parczew, Poland
      • Poznan, Poland
      • Radom, Poland
      • Rzeszow, Poland
      • Torun, Poland
      • Warswa, Poland
      • Wroclaw, Poland
      • Zgierz, Poland
      • Znin, Poland
  • Puerto Rico
      • Caguas, Puerto Rico
      • Ponce, Puerto Rico
      • San Juan, Puerto Rico
  • Romania
      • Brasov, Romania
      • Bucuresti, Romania
      • Cluj Napoca, Romania
      • Deva, Romania
      • Iasi, Romania
      • Oradea, Romania
      • Ploiesti, Romania
      • Targu Mures, Romania
      • Timisoara, Romania
  • Russian Federation
      • Arkhangelsk, Russian Federation
      • Barnaul, Russian Federation
      • Ivanovo, Russian Federation
      • Kemerovo, Russian Federation
      • Moscow, Russian Federation
      • Novosibirsk, Russian Federation
      • Petrozavodsk, Russian Federation
      • Rostov-on-Don, Russian Federation
      • Ryazan, Russian Federation
      • Saint Petersburg, Russian Federation
      • Saint-Petersburg, Russian Federation
      • Saratov, Russian Federation
      • Sestroretsk, Saint-Petersburg, Russian Federation
      • St. Petersburg, Russian Federation
      • Tomsk, Russian Federation
      • Ufa, Russian Federation
      • Volgograd, Russian Federation
      • Yaroslavl, Russian Federation
  • Serbia
      • Belgrade, Serbia
      • Nis, Serbia
      • Zajecar, Serbia
  • Slovakia
      • Bardejov, Slovakia
      • Bratislava, Slovakia
      • Kosice, Slovakia
      • Lubochna, Slovakia
      • Nitra, Slovakia
      • Prievidza, Slovakia
      • Puchov, Slovakia
      • Rimavska Sobota, Slovakia
      • Sturovo, Slovakia
      • Svidnik, Slovakia
      • Zilina, Slovakia
  • South Africa
      • Cape Town, South Africa
      • Durban, South Africa
      • Isipingo Rail, South Africa
      • Johannesburg, South Africa
      • Krugersdorp, South Africa
      • Port Elizabeth, South Africa
      • Pretoria, South Africa
      • Pretoria Gauteng, South Africa
      • Soweto, South Africa
  • Spain
      • A Coruna, Spain
      • Almeria, Spain
      • Barcelona, Spain
      • Burela, Spain
      • 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
      • Sevilla, Spain
      • Valencia, Spain
      • Vic, Spain
      • Viladecans, Spain
  • Taiwan
      • Kaohsiung, Taiwan
      • New Taipei City, Taiwan
      • Taichung, Taiwan
      • Taipei, Taiwan
  • Ukraine
      • Chernivtsi, Ukraine
      • Dnipropetrovsk, Ukraine
      • Ivano-Frankivsk, Ukraine
      • Kharkiv, Ukraine
      • Kiev, Ukraine
      • Kyiv, Ukraine
      • Ternopil, Ukraine
      • Vinnitsya, Ukraine
      • Vinnytsia, Ukraine
      • Zaporizhzhia, Ukraine
  • United Arab Emirates
      • Ajman, United Arab Emirates
      • Dubai, United Arab Emirates
      • Sharjah, United Arab Emirates
  • United Kingdom
      • 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
      • Leamington Spa, United Kingdom
      • Liskeard, United Kingdom
      • London, United Kingdom
      • Middlesbrough, United Kingdom
      • Plymouth, United Kingdom
      • Rhyl, 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
  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Montgomery, Alabama, United States
    • Arizona
      • Tempe, Arizona, United States
      • Tucson, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
      • Sherwood, Arkansas, United States
    • California
      • 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
    • Colorado
      • Denver, Colorado, United States
      • Golden, Colorado, United States
      • Lakewood, Colorado, United States
      • Washington, Colorado, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • 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
      • Saint Petersburg, Florida, United States
      • Winter Park, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Augusta, Georgia, United States
      • Columbus, Georgia, United States
      • Roswell, Georgia, United States
      • Snellville, Georgia, United States
      • Stockbridge, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
      • Crystal Lake, Illinois, United States
      • Gurnee, Illinois, United States
      • Mount Prospect, Illinois, United States
      • Winfield, Illinois, United States
    • Indiana
      • Fort Wayne, Indiana, United States
      • Indianapolis, Indiana, United States
      • Merrillville, Indiana, United States
      • Michigan City, Indiana, United States
      • Muncie, Indiana, United States
    • Iowa
      • Council Bluffs, Iowa, United States
    • Kentucky
      • Louisville, Kentucky, United States
      • Paducah, Kentucky, United States
    • Louisiana
      • Kenner, Louisiana, United States
    • Maine
      • Rockport, Maine, United States
      • Scarborough, Maine, United States
    • Maryland
      • Annapolis, Maryland, United States
      • Baltimore, Maryland, United States
      • Beltsville, Maryland, United States
      • Hyattsville, Maryland, United States
      • Silver Spring, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
      • Plymouth, Massachusetts, United States
      • Springfield, Massachusetts, United States
      • Worcester, Massachusetts, United States
    • Michigan
      • Flint, Michigan, United States
    • Mississippi
      • Jackson, Mississippi, United States
    • Missouri
      • Chesterfield, Missouri, United States
      • Kansas City, Missouri, United States
      • Saint Louis, Missouri, United States
    • Nebraska
      • Fremont, Nebraska, United States
      • Lincoln, Nebraska, United States
      • Omaha, Nebraska, United States
      • Reno, Nebraska, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Jersey
      • Eatontown, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • 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
    • North Carolina
      • 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
    • Ohio
      • Cincinnati, Ohio, United States
      • Columbus, Ohio, United States
      • Maumee, Ohio, United States
    • Oregon
      • Roseburg, Oregon, United States
    • Pennsylvania
      • Beaver, Pennsylvania, United States
      • Bethlehem, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • South Carolina
      • 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
    • Tennessee
      • Chattanooga, Tennessee, United States
      • Knoxville, Tennessee, United States
      • Memphis, Tennessee, United States
    • Texas
      • 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
    • Utah
      • Salt Lake City, Utah, United States
    • Vermont
      • Bennington, Vermont, United States
      • Burlington, Vermont, United States
    • Virginia
      • Bluefield, Virginia, United States
      • Mechanicsville, Virginia, United States
      • Norfolk, Virginia, United States
      • Suffolk, Virginia, United States
    • Washington
      • Spokane, Washington, United States
    • West Virginia
      • Huntington, West Virginia, United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Canagliflozin 100 mg
Each participant will receive 100 mg of canagliflozin once daily
Drug: Canagliflozin
One 100 mg over-encapsulated tablet orally once daily
Placebo Comparator: Placebo
Each participant will receive matching placebo once daily
Drug: Placebo
One matching placebo capsule orally (by mouth) once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Up to 4.6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite Endpoint of CV Death and Hospitalized Heart Failure (HHF)
Time Frame: Up to 4.6 years
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.
Up to 4.6 years
Major Adverse Cardiac Event (MACE)
Time Frame: Up to 4.6 years
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.
Up to 4.6 years
Hospitalized Heart Failure (HHF)
Time Frame: Up to 4.6 years
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.
Up to 4.6 years
Renal Composite Endpoint
Time Frame: Up to 4.6 years
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.
Up to 4.6 years
Cardiovascular (CV) Death
Time Frame: Up to 4.6 years
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.
Up to 4.6 years
All-cause Mortality
Time Frame: Up to 4.6 years
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.
Up to 4.6 years
CV Composite Endpoint
Time Frame: Up to 4.6 years
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.
Up to 4.6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Collaborators

The George Institute for Global Health, Australia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2014

Primary Completion (Actual)

October 30, 2018

Study Completion (Actual)

October 30, 2018

Study Registration Dates

First Submitted

February 17, 2014

First Submitted That Met QC Criteria

February 17, 2014

First Posted (Estimate)

February 19, 2014

Study Record Updates

Last Update Posted (Actual)

December 5, 2019

Last Update Submitted That Met QC Criteria

December 4, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR103517
  • 2013-004494-28 (EudraCT Number)
  • 28431754DNE3001 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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