| Outcome Measures: |
Primary: Number of partipants with all-cause mortality, kidney failure, and hospitalization for heart failure, To determine whether dapagliflozin is superior to placebo in reducing the incidence of the primary composite endpoint Combined endpoint of all-cause mortality, kidney failure, and hospitalization for heart failure in the overall study population, Total study duration intended to last 48 months | Secondary: Number of participants to reach all-cause mortality, To determine if dapagliflozin is superior to placebo in reducing the incidence of all-cause mortality, Total study duration intended to last 48 months|Incidence of hospitalization for heart failure, Incidence of hospitalization for heart failureTo determine if dapagliflozin is superior to placebo in reducing the incidence of heart failure, Total study duration intended to last 48 months|Incidence of kidney failure (chronic dialysis, kidney transplantation or mortality due to kidney failure), To determine if dapagliflozin is superior to placebo in reducing the incidence of kidney failure, Total study duration intended to last 48 months|incidence of the composite outcome (kidney failure, hospitalization for heart failure, and all-cause mortality) in subgroups, To determine whether dapagliflozin is superior to placebo in reducing the incidence of the composite outcome in subgroups subgroups: advanced CKD i.e. an eGFR ≤30 mL/min/1.73m2, dialysis patients and transplant patients, Total study duration intended to last 48 months | Other: measuring Quality of life with the EQ-5D questionnaire, To determine whether dapagliflozin is superior to placebo in comparing the Quality of Life for all subgroups based on the EQ-5D questionnaire, Total study duration intended to last 48 months|measuring Quality of life with the SF12 questionnaire, To determine whether dapagliflozin is superior to placebo in comparing the Quality of Life for all subgroups based onthe SF12 questionnaire, Total study duration intended to last 48 months|Cost-effectiveness of SGLT2-inhibition using the Quality of Life-data derived from the EQ-5D and SF-12 questionnaires, cost-effectiveness of SGLT2-inhibition in the overall study population as well as in the three subpopulations, Total study duration intended to last 48 months|incidence of de-novo type 2 diabetes in patients without diabetes, To determine whether dapagliflozin is superior to placebo in reducing the incidence of de-novo type 2 diabetes, Total study duration intended to last 48 months|Change in the eGFR slope, To determine whether dapagliflozin is superior to placebo in reducing the eGFR slope eGFR slope; for the dialysis subgroup slope residual kidney function will be calculated using the average of 24hr urinary creatinine and urea clearance values over time, Total study duration intended to last 48 months|incidence of diuresis <200 ml/24hr in the dialysis subgroup, To determine whether dapagliflozin is superior to placebo in the incidence of diuresis \<200 ml/24hr in the dialysis subgroup for this purpose 24hr urine samples will be collected ≥2 times per year, Total study duration intended to last 48 months|incidence of the composite outcome (kidney failure, hospitalization for heart failure, and all-cause mortality) in subgroups with and without type 2 diabetes separately, To determine if dapagliflozin is superior to placebo in reducing the incidence of kidney failure with and without type 2 diabetes separately, Total study duration intended to last 48 months
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| Locations: |
Canberra Health Services, Canberra, Australian Capital Teritory, Australia|Concord Repatriation General Hospital, Sydney, New South Wales, Australia|Liverpool Hospital, Sydney, New South Wales, Australia|Prince of Wales Hospital, Sydney, New South Wales, Australia|Royal North Shore Hospital, Sydney, New South Wales, Australia|Royal Prince Alfred Hospital, Sydney, New South Wales, Australia|St George Hospital, Sydney, New South Wales, Australia|Westmead Hospital, Sydney, New South Wales, Australia|Wollongong Hospital, Wollongong, New South Wales, Australia|Sunshine Coast Hospital and Health Services, Birtinya, Queensland, Australia|Royal Brisbane and Womens Hospital, Brisbane, Queensland, Australia|Townsville University hospital, Douglas, Queensland, Australia|Royal Adelaide Hospital, Adelaide, South Australia, Australia|Western Health, Melbourne, Victoria, Australia|Royal Melbourne Hospital, Parkville, Victoria, Australia|East Metro Health Services (Royal Perth Hospital and Armadale Health Services), Perth, Western Australia, Australia|Box Hill Hospital (Eastern Health), Melbourne, Australia|Charité, Berlin, 10117, Germany|Praxis für Dialyse und Nierenkrankheiten, Berlin, 12627, Germany|Universitätsklinikum Düsseldorf, Düsseldorf, 40225, Germany|Universitätsklinikum Erlangen, Erlangen, 91054, Germany|Universitätsklinikum Halle (Saale) Innere Medizin 2, Halle, 06120, Germany|Zentrum fuer Nieren-, Hochdruck- und Stoffwechselerkrankungen Hannover, Hannover, 30625, Germany|Nierenzentrum Heidelberg, Heidelberg, 69120, Germany|Dialysezentrum Heilbronn - Überörtliche Berufsausübungsgemeinschaft für Nephro und Dialyse (ÜBAG), Heilbronn, 74076, Germany|Universitätsklinikum JenaKlinik für Innere Medizin III, Jena, 07747, Germany|Universitätsmedizin Mainz, Mainz, 55131, Germany|Universitätsklinikum RegensburgAbteilung für Nephrologie, Regensburg, 93053, Germany|Universitätsklinikum Tübingen Medizinische Klinik IV, Tübingen, 72076, Germany|Universitätsklinikum Ulm, Klinik für Innere Medizin I, Nephrologie, Ulm, 89081, Germany|Nephrologisches Zentrum Villingen/Schwenningen, Villingen-Schwenningen, 678052, Germany|Nierenzentrum Wiesbaden, Wiesbaden, 2365191, Germany|Medizinische Klinik und Poliklinik I der Universitätsklinik WürzburgSchwerpunkt Nephrologie, Würzburg, 697080, Germany|Amphia Ziekenhuis, Breda, Noord-brabant, Netherlands|Amsterdam UMC, Amsterdam, Noord-Holland, Netherlands|Albert Schweitzer ziekenhuis, Dordrecht, Zuid-Holland, Netherlands|Noordwest Ziekenhuisgroep Alkmaar, Alkmaar, Netherlands|Meander Medisch Centrum, Amersfoort, Netherlands|Niercentrum aan de Amstel, Amstelveen, Netherlands|Dialysecentrum Dianet (Amsterdam), Amsterdam, Netherlands|Gelre Ziekenhuizen, Apeldoorn, Netherlands|Reinier de Graaf Ziekenhuis, Delft, Netherlands|Jeroen Bosch Ziekenhuis, Den Bosch, Netherlands|Deventer Ziekenhuis, Deventer, Netherlands|Catharina Ziekenhuis Eindhoven, Eindhoven, Netherlands|Maxima Medisch Centrum, Eindhoven, Netherlands|Martini Ziekenhuis, Groningen, Netherlands|UMCG, Groningen, Netherlands|Dialysecentrum Tergooi, Hilversum, Netherlands|Spaarne Gasthuis, Hoofddorp, Netherlands|Elyse klinieken voor nierzorg, Kerkrade, Netherlands|Medisch Centrum Leeuwarden, Leeuwarden, Netherlands|Leiden UMC, Leiden, Netherlands|St. Jansdal ziekenhuis, Lelystad, Netherlands|Maastricht UMC+, Maastricht, Netherlands|St. Antonius Ziekenhuis, Nieuwegein, Netherlands|Radboud UMC, Nijmegen, Netherlands|Bravis ziekenhuis, Roosendaal, Netherlands|Franciscus Gasthuis en Vlietland, Rotterdam, Netherlands|Bernhoven, Uden, Netherlands|Diakonessenhuis Utrecht, Utrecht, Netherlands|Dialysecentrum Dianet (Utrecht), Utrecht, Netherlands|UMC Utrecht, Utrecht, Netherlands|VieCuri Medisch Centrum, Venlo, Netherlands|Isala Ziekenhuis, Zwolle, Netherlands
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