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Design, recruitment, and baseline characteristics of the EMPA-KIDNEY trial
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-...
Formato: | Online Artículo Texto |
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Lenguaje: | English |
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Oxford University Press
2022
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9217655/ https://www.ncbi.nlm.nih.gov/pubmed/35238940 http://dx.doi.org/10.1093/ndt/gfac040 |
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collection | PubMed |
description | 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 <45 mL/min/1.73 m(2) or an eGFR ≥45 but <90 mL/min/1.73 m(2) 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 m(2) (SD 14.8), including 5185 (78%) with an eGFR <45 mL/min/1.73 m(2). The median uACR was 412 mg/g) (quartile 1–quartile 3 94–1190), with a uACR <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. |
format | Online Article Text |
id | pubmed-9217655 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-92176552022-06-23 Design, recruitment, and baseline characteristics of the EMPA-KIDNEY trial Nephrol Dial Transplant Original Article 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 <45 mL/min/1.73 m(2) or an eGFR ≥45 but <90 mL/min/1.73 m(2) 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 m(2) (SD 14.8), including 5185 (78%) with an eGFR <45 mL/min/1.73 m(2). The median uACR was 412 mg/g) (quartile 1–quartile 3 94–1190), with a uACR <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. Oxford University Press 2022-03-03 /pmc/articles/PMC9217655/ /pubmed/35238940 http://dx.doi.org/10.1093/ndt/gfac040 Text en © The Author(s) 2022. Published by Oxford University Press on behalf of the ERA. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Original Article Design, recruitment, and baseline characteristics of the EMPA-KIDNEY trial |
title | Design, recruitment, and baseline characteristics of the EMPA-KIDNEY trial |
title_full | Design, recruitment, and baseline characteristics of the EMPA-KIDNEY trial |
title_fullStr | Design, recruitment, and baseline characteristics of the EMPA-KIDNEY trial |
title_full_unstemmed | Design, recruitment, and baseline characteristics of the EMPA-KIDNEY trial |
title_short | Design, recruitment, and baseline characteristics of the EMPA-KIDNEY trial |
title_sort | design, recruitment, and baseline characteristics of the empa-kidney trial |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9217655/ https://www.ncbi.nlm.nih.gov/pubmed/35238940 http://dx.doi.org/10.1093/ndt/gfac040 |
work_keys_str_mv | AT designrecruitmentandbaselinecharacteristicsoftheempakidneytrial |