Rationale and protocol of the Dapagliflozin And Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD) randomized controlled trial
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Rationale and protocol of the Dapagliflozin And Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD) randomized controlled trial. / Heerspink, H. J.L.; Stefansson, B.; Chertow, G.; Correa-Rotter, R.; Greene, Tom; Hou, Fan Fan; Lindberg, Magnus; McMurray, John; Rossing, P.; Toto, Roberto; Langkilde, Anna Maria; Wheeler, David C.; Heerspink, H. J.L.; Wheeler, D. C.; Chertow, G.; Correa-Rotter, R.; Greene, T.; Hou, F. F.; McMurray, J.; Rossing, P.; Toto, R.; Stefansson, B.; Langkilde, A. M.; Pfeffer, Marc A.; Pocock, Stuart; Swedberg, Karl; Rouleau, Jean L.; Chaturvedi, Nishi; Ivanovich, Peter; Levey, Andrew S.; Christ-Schmidt, Heidi; Mann, Johannes; Held, Claes; Varenhorst, Christoph; Holmgren, Pernilla; Hallberg, Theresa; Douthat, Walter; Filho, Roberto Pecoits; Cherney, David; Hou, Fan Fan; Persson, Frederik; Haller, Hermann; Wittmann, István; Khullar, Dinesh; Naoki, Kashihara; Correa-Rotter, Richardo; Escudero, Elizabeth; Isidto, Rey; Nowicki, Michal; Batiushin, Mikhail; DAPA-CKD Investigators.
I: Nephrology Dialysis Transplantation, Bind 35, Nr. 2, 02.2020, s. 274-282.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Rationale and protocol of the Dapagliflozin And Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD) randomized controlled trial
AU - Heerspink, H. J.L.
AU - Stefansson, B.
AU - Chertow, G.
AU - Correa-Rotter, R.
AU - Greene, Tom
AU - Hou, Fan Fan
AU - Lindberg, Magnus
AU - McMurray, John
AU - Rossing, P.
AU - Toto, Roberto
AU - Langkilde, Anna Maria
AU - Wheeler, David C.
AU - Heerspink, H. J.L.
AU - Wheeler, D. C.
AU - Chertow, G.
AU - Correa-Rotter, R.
AU - Greene, T.
AU - Hou, F. F.
AU - McMurray, J.
AU - Rossing, P.
AU - Toto, R.
AU - Stefansson, B.
AU - Langkilde, A. M.
AU - Pfeffer, Marc A.
AU - Pocock, Stuart
AU - Swedberg, Karl
AU - Rouleau, Jean L.
AU - Chaturvedi, Nishi
AU - Ivanovich, Peter
AU - Levey, Andrew S.
AU - Christ-Schmidt, Heidi
AU - Mann, Johannes
AU - Held, Claes
AU - Varenhorst, Christoph
AU - Holmgren, Pernilla
AU - Hallberg, Theresa
AU - Douthat, Walter
AU - Filho, Roberto Pecoits
AU - Cherney, David
AU - Hou, Fan Fan
AU - Persson, Frederik
AU - Haller, Hermann
AU - Wittmann, István
AU - Khullar, Dinesh
AU - Naoki, Kashihara
AU - Correa-Rotter, Richardo
AU - Escudero, Elizabeth
AU - Isidto, Rey
AU - Nowicki, Michal
AU - Batiushin, Mikhail
AU - DAPA-CKD Investigators
PY - 2020/2
Y1 - 2020/2
N2 - 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.
AB - 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.
KW - Chronic kidney disease
KW - Dapagliflozin
KW - Randomized controlled clinical trial
KW - Sodiumglucose co-transporter inhibitor
U2 - 10.1093/ndt/gfz290
DO - 10.1093/ndt/gfz290
M3 - Journal article
C2 - 32030417
AN - SCOPUS:85079082162
VL - 35
SP - 274
EP - 282
JO - Nephrology, Dialysis, Transplantation
JF - Nephrology, Dialysis, Transplantation
SN - 0931-0509
IS - 2
ER -
ID: 243422595