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The Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) Study Rationale, Design, and Baseline Characteristics

Title:	The Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) Study Rationale, Design, and Baseline Characteristics
Authors:	Abdallah J; Abdul Ghani R; Abdul Kadir K; Abdullah R; Abejuela Z; Abraham O; Abramowitz M; Abusnana S; Accini Mendoza JL; Acosta I; Agafyina A; Aggarwal N; Ahmed F; Ahuad Guerrero RA; Aiello J; Ainsworth P; Aizenberg D; Akiyama H; Akright L; Akyea-Djamson A; Alamartine E; Alappan R; Ali N; Ali Z; Alicic R; Al-Karadsheh A; Alpizar Salazar M; Alvarez Garcia P; Alvarisqueta A; Amodeo C; Andreeva V; Andreotti Turatti LA; Angelescu LM; Angelova A; Anghel V; Antic S; Aoki H; Aquitania G; Arauz-Pacheco C; Arce-Nunez E; Arcos Palma EG; Arfeen S; Arif A; Aronson R; Arutchelvam V; Asano A; Atray N; Avram RI; Awad A; Baas Cruz J; Babikova J; Badat A; Bajaj H; Baker J; Bakris G; Barbarash O; Barna O; Barnard M; Barranco E; Barrera C; Bartaskova D; Bartolacci I; Barysheva O; Behara V; Bellary S; Belo D; Bentley-Lewis R; Benusova O; Berenguer R; Berli MA; Bernardo M; Biscoveanu M; Bordonava AP; Borot S; Botsyurko V; Bowman-Stroud C; Brandon D; Bregman R; Brusco O; Buganova I; Burgos Soto M; Busch R; Busegeanu MM; Calella P; Camelo Sanches FC; Canaan Y; Canani LH; Cantero MC; Cariou B; Cartasegna LR; Castellino P; Cereto Castro F; Certow G; Chacra AR; Chae DW; Chang CT; Chang T; Che Yusof MD; Chen N; Chen Q; Cherney D; Cheung NW; Chevaile Ramos J; Chew Wong A; Chiovato L; Chizhov D; Cho YM; Christiano C; Christofides E; Chuang LM; Chuateco C; Cif A; Cigarran Guldris S; Cohen K; Cohen R; Coloma GC; Comia RS; Commendatore V; Conway J; Cook C; Cosma D; Cournoyer S; Coyne D; Crisan C; Csecsei G; Csiky B; Cuadrado J; Cuneo CA; Cunha Borges JL; Cunha Vêncio SA; Cusumano AM; da Silva Franco RJ; Daboul N; Danos P; DaRoza G; Davies E; Davies M; Davies S; Dawson A; De Cosmo S; De Nicola L; De Serres S; de Souza Portes E; Deak L; Deck K; Deepak D; Derosa G; Desouza C; Dev D; Dhillon M; DI CARLO, Alfonso; Di Cianni G; Diaz Escalante T; Dimitrov S; Distiller L; Djordjevic M; Dobronravov V; Dohnalova L; Dominguez Lopez M; Douthat WG; Dran RD; Drasnar T; Dreval A; Droste C; Dua S; Dube F; Dudar I; Dudas M; Dussol B; Dzupina A; Eder F; Egido de Los Rios J; El Kossi M; El-Shahawy M; English P; Enriquez Sosa FE; Ervin J; Esquenazi A; Evans J; Faghih M; Farias E; Faulmann G; Fauvel JP; Ferariu IE; Fernandez MF; Fernandez Fresnedo G; Fernandez Montenegro MA; Finkelstein H; Flores Lozano F; Flota Cervera L; Fraige Filho F; Fraser D; Frenk Baron P; Fretes JO; Frias J; Fuiano G; Fulop P; Fushtey I; Galan Serrano A; Galphin C; Gan S; Gan CL; Garcia NH; Garcia I; Garcia Ballesteros C; Garcia Ortiz LH; Garrido N; Gastaldi A; Gelersztein E; Geloneze Neto B; Genadieva V; Genova-Hristova G; Genovese S; Ghazi A; Giorda C; Glenny JA; Glinkina I; Godlevska O; Godoy Jorquera JG; Goldenberg R; Golovchenko O; Gomes Bastos M; Gomez O; Gomez Rangel JD; Gonzalez E; Gonzalez Dorado A; Gonzalez Martinez FJ; Gonzalez Orellana RA; Gopalakrishnan N; Gorriz JL; Gorson D; Govender V; Gracious N; Greco B; Gregar R; Greloni GC; Grineva E; Guinsburg A; Gulati R; Gunstone A; Gupta A; Gupta M; Gyrina O; Hadjadj S; Halciakova K; Hall T; Haller H; Halmagyi I; Hammoud J; Hancu N; Hanif W; Hansraj A; Hawley C; Henein S; Hermida S; Hernandez Triana E; Herrera Jimenez LE; Hershon K; Higuera Cobos JD; Hiser D; Hocking S; Hon G; Hristozov K; Hsieh CH; Hura C; Hwang SJ; Ilavska A; Irizar Santana SS; Ismail M; Jackson A; Jain D; Jamal A; Januszewicz A; Jeong IK; Jha V; Jimenez Flores F; Jodar Gimeno JE; Johnson A; Joseph F; Joshi M; Juncos LI; Jurgens J; Kajiyama S; Kaminska A; Kashine S; Kaupke C; Kawada T; Keiko Kohara S; Keitel E; Keltai K; Kendereski A; Keresztesi S; Kern E; Kerr Saraiva JF; Keshavamurthy CB; Khandwala H; Khanna R; Khitan Z; Khullar D; Kim SG; Kim YH; Kim S; Kiss K; Klein A; Klyver MI; Kodera T; Kolesnyk M; Kolmakova E; Komisarenko I; Kong Y; Kong WY; Kono H; Konyves L; Kopyt N; Korzh O; Kovar R; Kovesdy C; Koyama K; Kozloviene D; Kraft F; Krane V; Kravchun N; Krishna G; Krishnan S; Kropp JJ; Kumar A; Kumar J; Kumeda Y; Kumwenda M; Kurtz Lisboa HR; Kvitkova L; Kwon HS; Kwon MJ; Lalic K; Lalic N; Lanchiotti PV; Lastuvka J; Laviada Molina H; Lawrence M; Le Meur Y; Lee LY; Lee BW; Lee J; Lee MK; Legun O; Leiter L; Lentz J; Leon de la Fuente RA; Levin A; Lewis D; Li D; Li W; Li X; Lim SK; Lin H; Lin CC; Liss K; Liu J; Loh CL; Lombard L; Lopez Mendoza M; Lopez Tarabay C; Lorenzoni d'avila DO; Loss de Carvalho Contieri F; Lu W; Lu YC; Luna Ceballos R; M. Edwin F; MacDougall I; Macedo de Souza PA; Madej A; Madore F; Magalhaes Montenegro Junior R; Mah PM; Maheshwari H; Major L; Malberti F; Malek Marin T; Mandayam S; Mandreoli M; Manisha S; Mankovskyy B; Mannucci E; Manocha AB; Mao H; Marar I; Marasaev V; Marchetta N; Martin Del Campo Blanco B; Martinka E; Martynyuk L; Maxeiner S; Mazur S; McMahon A; Medina Farina M; Mehta B; Middleton J; Mileder M; Miyauchi S; Mizuyama K; Mkrtumyan A; Mlodawska-Choluj D; Molina de Salazar DI; Molnar M; Mookadam M; Morales Franco G; Morales Portillo C; Mordujovich J; Moreira de Brito C; Moreira Diaz JP; Moreno Loza OT; Mostovoy Y; Moustafa M; Muirhead N; Mujica Trenche S; Munar Vila MA; Munoz Torres M; Munteanu M; Mustieles Rocha C; Nagibovich G; Nam MS; Narvarte J; Nasser Hissa M; Navickas A; Nazario Sabbag ÂR; Nedogoda S; Negru D; Newman G; Ng KS; Ngcakani N; Nicholls K; Nicol P; Nieto Iglesias J; Niiya T; Nik Ahmad NNF; Nisnisan J; Nonchev B; Noronha IL; Nortje H; Nossuli AK; Nowicki M; Obialo C; Obrador Vera G; Ochodnicka Z; Oh KH; Oishi H; Olelewe S; Oliver M; Oosthuizen H; Orio SI; Orlowska-Kowalik G; Oroszlan T; Orozco Castellanos R; Orsi E; Ory I; O'Shaughnessy A; Ota S; Otreras F; Oviedo A; Packham D; Padron J; Panarotto D; Pankhaniya R; Pantoja Perez J; Paragh G; Park CY; Park SH; Pashkovska N; Patel D; Patel G; Pavon H; Pei D; Pella D; Penfornis A; Peralta Calcaneo J; Pereira MA; Pererva L; Perez Vera M; Peringat J; Pertseva T; Pesickova S; Peterfai E; Peterka K; Petrica L; Petro G; Pettis K; Pharr W; Philip S; Phillips A; Piatti P; Pichette V; Pontiroli A; Popa AR; Popenda G; Popovic-Radinovic V; Portoles Perez JM; Prasad N; Proietto J; Prozesky H; Pumprla J; Purighalla R; Quesada Simon MA; Quesada-Suarez L; Rabasa-Lhoret R; Ramirez Roca LA; Ramtoola S; Ranetti AE; Rangelov R; Ranjan R; Raskina T; Rastogi S; Ratnasingam V; Reddy J; Ren Y; Resk JH; Rewerska B; Reyes Rosano MA; Rich L; Rista L; Roberts A; Robinson M; Rodelo J; Rodriguez H; Rodriguez Papini N; Roger S; Rosas S; Rosas Guzman J; Rosivall L; Roussel R; Rucker Joerg IE; Rychlik I; Saavedra Gajardo V; Saavedra Sanchez SB; Sala J; Samoylov O; Samoylova Y; Sanchez Arenales JA; Sanchez Mijangos JH; Sanchez Polo JV; Sankaram R; Santoro D; Santos JC; Santos F; Sarin R; Saudek F; Saumell F; Saxena M; Sazonova O; Schiavi LB; Schiller A; Schuch T; Scott R; Scott D; Seeber M; Seiji Yamada S; Sekkarie M; Sensenbrenner J; Serafinceanu C; Serrano Sanson P; Sessa H; Shakeel M; Shamkhalova M; Shanik M; Shaw S; Sheu WH; Shinkov A; Shutemova E; Silva Pecoits Filho RF; Simo Canonge R; Simoes de Almeida R; Simon G; Singh B; Slompo Ramos C; Smatanova I; Smirnov I; Smith S; Smith Casabella T; Soares Felicio J; Soler Romeo MJ; Solomon R; Song W; Soto Gonzalez A; Sowinski D; Sprague A; Sree Bhushan R; Sreedhar R; Sreelatha M; Steele A; SPEDDING, Stephen John; Strzelecka A; Suchinda P; Sudhakar B; Sun J; Sun L; Surampudi P; Sussman S; Svyshchenko Y; Symonds R; Szlachcic Y; Takacs R; Takai M; Tamayo Y. Orozco J; Tan G; Tellez Chavez E; Temelkova M; Terns Riera M; Terront Lozano MA; Tesar V; Thompson M; Tibes Hachmann JC; Tinahones Madueno FJ; Tolentino M; Tomashkevych H; Tomonaga O; Topchii I; Torshizi A; Trespalacios F; Trevisan R; Trueba P; Tryshchuk N; Tseluyko V; Tsujimoto M; Tu P; Turcios Juarez E; Turner W; Twahirwa M; Ulla MR; Updegrove J; Urbanaviciene E; Valderrama Cometa L; Valdes Cepeda A; Valenzuela A; Valis M; Vallejos A; Vangel S; Vannorsdall M; Vargas Alonso RD; Varghese F; Vasas S; Vazelov E; Vejar M; Velasquez-Mieyer P; Velichkova E; Velo M; Venegas Carrillo L; Vengadasalam P; Ventrapragada S; Villagordoa Mesa J; Villarino AA; Villegas I; Visco VE; Vizir V; Vlasenko M; Vyasam RC; Wada T; Wadud K; Wahba M; Wakasugi M; Wakeling J; Wakida Y; WALKER, JOHN RICHARD; Wang G; Warren M; Wassermann A; Watanabe T; Watson E; Watts R; Weiner P; Weiner D; Welsh J; Wheeler D; Williams M; Winocour P; Woo V; Yamada M; Yanagida K; Yanase T; Yang J; Yao C; Yap YE; Ygpuara MDL; Yin A; Yoiti Hayashida C; Yoon KH; Young S; Yu X; Yumita W; Yupanqui H; Zaidman CJ; Zamarripa Escobedo R; Zanata Petry TB; Zanella MT; Zaoui P; Zavaroni I; Zemek S; Zhang H; Zhao M; Zheng H; Zlova T; Zsom M; Zykova T.
Contributors:	Abdallah, J; Abdul Ghani, R; Abdul Kadir, K; Abdullah, R; Abejuela, Z; Abraham, O; Abramowitz, M; Abusnana, S; Accini Mendoza, Jl; Acosta, I; Agafyina, A; Aggarwal, N; Ahmed, F; Ahuad Guerrero, Ra; Aiello, J; Ainsworth, P; Aizenberg, D; Akiyama, H; Akright, L; Akyea-Djamson, A; Alamartine, E; Alappan, R; Ali, N; Ali, Z; Alicic, R; Al-Karadsheh, A; Alpizar Salazar, M; Alvarez Garcia, P; Alvarisqueta, A; Amodeo, C; Andreeva, V; Andreotti Turatti, La; Angelescu, Lm; Angelova, A; Anghel, V; Antic, S; Aoki, H; Aquitania, G; Arauz-Pacheco, C; Arce-Nunez, E; Arcos Palma, Eg; Arfeen, S; Arif, A; Aronson, R; Arutchelvam, V; Asano, A; Atray, N; Avram, Ri; Awad, A; Baas Cruz, J; Babikova, J; Badat, A; Bajaj, H; Baker, J; Bakris, G; Barbarash, O; Barna, O; Barnard, M; Barranco, E; Barrera, C; Bartaskova, D; Bartolacci, I; Barysheva, O; Behara, V; Bellary, S; Belo, D; Bentley-Lewis, R; Benusova, O; Berenguer, R; Berli, Ma; Bernardo, M; Biscoveanu, M; Bordonava, Ap; Borot, S; Botsyurko, V; Bowman-Stroud, C; Brandon, D; Bregman, R; Brusco, O; Buganova, I; Burgos Soto, M; Busch, R; Busegeanu, Mm; Calella, P; Camelo Sanches, Fc; Canaan, Y; Canani, Lh; Cantero, Mc; Cariou, B; Cartasegna, Lr; Castellino, P; Cereto Castro, F; Certow, G; Chacra, Ar; Chae, Dw; Chang, Ct; Chang, T; Che Yusof, Md; Chen, N
Publication Year:	2017
Collection:	Università degli Studi della Campania "Luigi Vanvitelli": CINECA IRIS V:
Subject Terms:	Canagliflozin; Chronic kidney disease; Diabetic nephropathy; Renal outcome; Nephrology
Description:	Background: People with diabetes and kidney disease have a high risk of cardiovascular events and progression of kidney disease. Sodium glucose co-transporter 2 inhibitors lower plasma glucose by reducing the uptake of filtered glucose in the kidney tubule, leading to increased urinary glucose excretion. They have been repeatedly shown to induce modest natriuresis and reduce HbA1c, blood pressure, weight, and albuminuria in patients with type 2 diabetes. However, the effects of these agents on kidney and cardiovascular events have not been extensively studied in patients with type 2 diabetes and established kidney disease. Methods: The Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial aims to compare the efficacy and safety of canagliflozin Âversus placebo at preventing clinically important kidney and cardiovascular outcomes in patients with diabetes and established kidney disease. CREDENCE is a randomized, double-blind, event-driven, placebo-controlled trial set in in 34 countries with a projected duration of âˆ1⁄45.5 years and enrolling 4,401 adults with type 2 diabetes, estimated glomerular filtration rate â‰¥30 to 300 to â‰¤5,000 mg/g). The study has 90% power to detect a 20% reduction in the risk of the primary outcome (Î± = 0.05), the composite of end-stage kidney disease, doubling of serum creatinine, and renal or cardiovascular death. Conclusion: CREDENCE will provide definitive evidence about the effects of canagliflozin on renal (and cardiovascular) outcomes in patients with type 2 diabetes and established kidney disease. Trial Registration: EudraCT number: 2013-004494-28; ClinicalTrials.gov identifier: NCT02065791.
Document Type:	article in journal/newspaper
Language:	English
Relation:	info:eu-repo/semantics/altIdentifier/pmid/29253846; info:eu-repo/semantics/altIdentifier/wos/WOS:000418899500005; volume:46; issue:6; firstpage:462; lastpage:472; numberofpages:11; journal:AMERICAN JOURNAL OF NEPHROLOGY; https://hdl.handle.net/11591/384136; www.karger.ch/journals/ajn/ajn_jh.htm
DOI:	10.1159/000484633
Availability:	https://hdl.handle.net/11591/384136; https://doi.org/10.1159/000484633
Accession Number:	edsbas.3B32D70D
Database:	BASE