Design, recruitment, and baseline characteristics of the EMPA-KIDNEY trial
Authors:   The EMPA-KIDNEY Collaborative Group, Herrington William G , Wanner Christoph , Green Jennifer B , Hauske Sibylle J , Judge Parminder , Mayne Kaitlin J , Ng Sarah Y A , Sammons Emily , Zhu Doreen , Staplin Natalie , Preiss David , Stevens Will , Wallendszus Karl , Dayanandan Rejive , Knott Carol , Hill Michael , Emberson Jonathan , Brenner Susanne , Cejka Vladimir , Cheung Alfred K , Liu Zhihong , Li Jing , Chen Peiling , Hooi Laiseong , Liu Wen , Kadowaki Takashi , Nangaku Masaomi , Levin Adeera , Cherney David , Pontremoli Roberto , Maggioni Aldo Pietro , Goto Shinya , Tomita Aiko , Deo Rajat , Tuttle Katherine , Eilbracht Jens , Hantel Stefan , Hopley Mark , Landray Martin J , Baigent Colin , Haynes Richard , Baigent Colin , Landray Martin J , Wanner Christoph , Herrington William G , Haynes Richard , Green Jennifer B , Hauske Sibylle J , Brueckmann Martina , Hopley Mark , Brenner Susanne , Cheung Alfred K , Preiss David , Liu Zhihong , Li Jing , Hooi Laiseong , Liu Wen , Kadowaki Takashi , Nangaku Masaomi , Levin Adeera , Cherney David , Pontremoli Roberto , Maggioni Aldo Pietro , Staplin Natalie , Emberson Jonathan , Hantel Stefan , Goto Shinya , Deo Rajat , Tuttle Katherine , Ng Sarah Y A , Lozano Francisco Javier Rossello , Sammons Emily , Zhu Doreen , Sandercock Peter , Bilous Rudolf , Herzog Charles , Whelton Paul , Wittes Janet , Bennett Derrick , Burke Andy , Brown Richard , Dayanandan Rejive , Fletcher Lucy , Gosling Hannah , Harding Emily , Haynes Richard , Herrington William G , Judge Parminder , Knott Carol , Lee Ryonfa , Murphy Kevin , Qiao Yanru , Raff Rachel , Yu Hui , Qiao YanRu , Cejka Vladimir , Fajardo-Moser Marcela , Lorimer Andrea , Lucci Donata , Hepditch Anita , Axler Amanda , Chen Peiling , Hao Dai , Goh Cheng Beng , Sivanandam Sarojini , Hashimoto Akiko , Negoro Wakako , Tomita Aiko , Tomoko Morisaki 
Published: February 2022

ABSTRACT

Background
The effects of the sodium-glucose co-transporter 2 inhibitor empagliflozin on renal and cardiovascular disease have not been tested in a dedicated population of people with chronic kidney disease (CKD).

Methods
The EMPA-KIDNEY trial is an international randomized, double-blind, placebo-controlled trial assessing whether empagliflozin 10 mg daily decreases the risk of kidney disease progression or cardiovascular death in people with CKD. People with or without diabetes mellitus (DM) were eligible provided they had an estimated glomerular filtration rate (eGFR) ≥20 but &lt;45 mL/min/1.73 m2 or an eGFR ≥45 but &lt;90 mL/min/1.73 m2 with a urinary albumin:creatinine ratio (uACR) ≥200 mg/g. The trial design is streamlined, as extra work for collaborating sites is kept to a minimum and only essential information is collected.

Results
Between 15 May 2019 and 16 April 2021, 6609 people from eight countries in Europe, North America and East Asia were randomized. The mean age at randomization was 63.8 years [standard deviation (SD) 13.9)], 2192 (33%) were female and 3570 (54%) had no prior history of DM. The mean eGFR was 37.5 mL/min/1.73 m2 (SD 14.8), including 5185 (78%) with an eGFR &lt;45 mL/min/1.73 m2. The median uACR was 412 mg/g) (quartile 1–quartile 3 94–1190), with a uACR &lt;300 mg/g in 3194 (48%). The causes of kidney disease included diabetic kidney disease [n = 2057 (31%)], glomerular disease [n = 1669 (25%)], hypertensive/renovascular disease [n = 1445 (22%)], other [n = 808 (12%)] and unknown causes [n = 630 (10%)].

Conclusions
EMPA-KIDNEY will evaluate the efficacy and safety of empagliflozin in a widely generalizable population of people with CKD at risk of kidney disease progression. Results are anticipated in 2022.