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Rationale and proto...
Rationale and protocol of the Dapagliflozin And Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD) randomized controlled trial.
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Heerspink, Hiddo J L (author)
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Stefansson, Bergur V (author)
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Chertow, Glenn M (author)
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Correa-Rotter, Ricardo (author)
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Greene, Tom (author)
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Hou, Fan-Fan (author)
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Lindberg, Magnus (author)
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McMurray, John (author)
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Rossing, Peter (author)
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Toto, Roberto (author)
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Langkilde, Anna Maria (author)
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Wheeler, David C (author)
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- Held, Claes (author)
- Uppsala universitet,Uppsala kliniska forskningscentrum (UCR),Institutionen för medicinska vetenskaper,kardiologi
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(creator_code:org_t)
- 2020-02-07
- 2020
- English.
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In: Nephrology, Dialysis and Transplantation. - : Oxford University Press (OUP). - 0931-0509 .- 1460-2385. ; 35:2, s. 274-282
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https://doi.org/10.1...
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Abstract
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- BACKGROUND: Recent cardiovascular outcome trials have shown that sodium-glucose co-transporter 2 (SGLT2) inhibitors slow the progression of chronic kidney disease (CKD) in patients with type 2 diabetes at high cardiovascular risk. Whether these benefits extend to CKD patients without type 2 diabetes or cardiovascular disease is unknown. The Dapagliflozin and Prevention of Adverse Outcomes in CKD (DAPA-CKD) trial (NCT03036150) will assess the effect of the SGLT2 inhibitor dapagliflozin on renal and cardiovascular events in a broad range of patients with CKD with and without diabetes.METHODS: DAPA-CKD is a randomized, double-blind, placebo-controlled, trial in which ∼4300 patients with CKD Stages 2-4 and elevated urinary albumin excretion will be enrolled. The vast majority will be receiving a maximum tolerated dose of a renin-angiotensin system inhibitor at enrolment.RESULTS: After a screening assessment, eligible patients with a urinary albumin:creatinine ratio ≥200 mg/g and estimated glomerular filtration rate (eGFR) between 25 and 75 mL/min/1.73 m2 are randomly assigned to placebo or dapagliflozin 10 mg/day. Enrolment is monitored to ensure that at least 30% of patients do not have diabetes and that no more than 10% have an eGFR >60 mL/min/1.73 m2. The primary endpoint is a composite of a sustained decline in eGFR of ≥50%, end-stage renal disease, renal death or cardiovascular death. The trial will conclude when 681 primary renal events have occurred, providing 90% power to detect a 22% relative risk reduction (α level of 0.05).CONCLUSION: DAPA-CKD will determine whether the SGLT2 inhibitor dapagliflozin, added to guideline-recommended therapies, safely reduces the rate of renal and cardiovascular events in patients across multiple CKD stages with and without diabetes.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
Keyword
- chronic kidney disease
- dapagliflozin
- randomized controlled clinical trial
- sodium–glucose co-transporter inhibitor
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Heerspink, Hiddo ...
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Stefansson, Berg ...
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Chertow, Glenn M
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Correa-Rotter, R ...
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Greene, Tom
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Hou, Fan-Fan
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show more...
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Lindberg, Magnus
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McMurray, John
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Rossing, Peter
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Toto, Roberto
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Langkilde, Anna ...
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Wheeler, David C
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Held, Claes
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show less...
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cardiac and Card ...
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Nephrology, Dial ...
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Uppsala University