Forskning
Udskriv Udskriv
Switch language
Region Hovedstaden - en del af Københavns Universitetshospital
Udgivet

Rationale and protocol of the Dapagliflozin And Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD) randomized controlled trial

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

DOI

  1. Adrenal insufficiency in kidney transplant patients during low-dose prednisolone therapy: a cross-sectional case-control study

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. The dapagliflozin and prevention of adverse outcomes in chronic kidney disease (DAPA-CKD) trial: baseline characteristics

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Short-term effect of the New Nordic Renal Diet on phosphorus homoeostasis in chronic kidney disease Stages 3 and 4

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  • DAPA-CKD Investigators
Vis graf over relationer

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 (a 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.

OriginalsprogEngelsk
TidsskriftNephrology Dialysis Transplantation
Vol/bind35
Udgave nummer2
Sider (fra-til)274-282
Antal sider9
ISSN0931-0509
DOI
StatusUdgivet - 7 feb. 2020

Bibliografisk note

© The Author(s) 2020. Published by Oxford University Press on behalf of ERA-EDTA.

ID: 59268920