Design, recruitment, and baseline characteristics of the EMPA-KIDNEY trial
<p><strong>Background:</strong> 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).</p> <p><strong>Methods:</...
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| Eará dahkkit: | |
| Materiálatiipa: | Journal article |
| Giella: | English |
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Oxford University Press
2022
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| _version_ | 1826308284220440576 |
|---|---|
| author | Herrington, W Wanner, C Green, JB |
| author2 | The EMPA-KIDNEY Collaborative Group |
| author_facet | The EMPA-KIDNEY Collaborative Group Herrington, W Wanner, C Green, JB |
| author_sort | Herrington, W |
| collection | OXFORD |
| description | <p><strong>Background:</strong> 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).</p>
<p><strong>Methods:</strong> The EMPA-KIDNEY trial is an international randomized, double-blind, placebo-controlled trial assessing whether empagliflozin 10 mg daily reduces risk of kidney disease progression or cardiovascular death in people with CKD. People with or without diabetes mellitus (DM) were eligible provided they had: (i) an estimated glomerular filtration rate (eGFR) ≥20, <45 mL/min/1.73m2; or (ii) an eGFR ≥45, <90 mL/min/1.73m2 with a urinary albumin:creatinine ratio (uACR) ≥200 mg/g. The trial design is streamlined: extra work for collaborating sites is kept to a minimum, and only essential information is collected.</p>
<p><strong>Results:</strong> Between 15 May 2019 and 16 April 2021, 6609 people from eight countries in Europe, North America and East Asia were randomized. Mean age at randomization was 63.8 (SD 13.9) years, 2193 (33%) were female, and 3569 (54%) had no prior history of DM. Mean eGFR was 37.5 (14.8) mL/min/1.73m2, including 5185 (78%) with an eGFR <45 mL/min/1.73m2. Median (Q1-Q3) uACR was 331 (50-1079) mg/g, with a uACR <300 mg/g in 3198 (48%). The causes of kidney disease included diabetic kidney disease (n=2058 [31%]), glomerular disease (n=1669 [25%]), hypertensive/renovascular disease (n=1444 [22%]), other (n=808 [12%]), and unknown causes (n=630 [10%]).</p>
<p><strong>Conclusions:</strong> 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.</p> |
| first_indexed | 2024-03-07T07:15:44Z |
| format | Journal article |
| id | oxford-uuid:b6625c25-7702-4be2-a276-4ff4f14a15aa |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T07:15:44Z |
| publishDate | 2022 |
| publisher | Oxford University Press |
| record_format | dspace |
| spelling | oxford-uuid:b6625c25-7702-4be2-a276-4ff4f14a15aa2022-08-15T11:09:27ZDesign, recruitment, and baseline characteristics of the EMPA-KIDNEY trialJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:b6625c25-7702-4be2-a276-4ff4f14a15aaEnglishSymplectic ElementsOxford University Press2022Herrington, WWanner, CGreen, JBThe EMPA-KIDNEY Collaborative Group<p><strong>Background:</strong> 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).</p> <p><strong>Methods:</strong> The EMPA-KIDNEY trial is an international randomized, double-blind, placebo-controlled trial assessing whether empagliflozin 10 mg daily reduces risk of kidney disease progression or cardiovascular death in people with CKD. People with or without diabetes mellitus (DM) were eligible provided they had: (i) an estimated glomerular filtration rate (eGFR) ≥20, <45 mL/min/1.73m2; or (ii) an eGFR ≥45, <90 mL/min/1.73m2 with a urinary albumin:creatinine ratio (uACR) ≥200 mg/g. The trial design is streamlined: extra work for collaborating sites is kept to a minimum, and only essential information is collected.</p> <p><strong>Results:</strong> Between 15 May 2019 and 16 April 2021, 6609 people from eight countries in Europe, North America and East Asia were randomized. Mean age at randomization was 63.8 (SD 13.9) years, 2193 (33%) were female, and 3569 (54%) had no prior history of DM. Mean eGFR was 37.5 (14.8) mL/min/1.73m2, including 5185 (78%) with an eGFR <45 mL/min/1.73m2. Median (Q1-Q3) uACR was 331 (50-1079) mg/g, with a uACR <300 mg/g in 3198 (48%). The causes of kidney disease included diabetic kidney disease (n=2058 [31%]), glomerular disease (n=1669 [25%]), hypertensive/renovascular disease (n=1444 [22%]), other (n=808 [12%]), and unknown causes (n=630 [10%]).</p> <p><strong>Conclusions:</strong> 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.</p> |
| spellingShingle | Herrington, W Wanner, C Green, JB 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 |
| work_keys_str_mv | AT herringtonw designrecruitmentandbaselinecharacteristicsoftheempakidneytrial AT wannerc designrecruitmentandbaselinecharacteristicsoftheempakidneytrial AT greenjb designrecruitmentandbaselinecharacteristicsoftheempakidneytrial |