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

被引:142
作者
Wheeler, David C. [1 ]
Stefansson, Bergur, V [2 ]
Batiushin, Mikhail [3 ]
Bilchenko, Oleksandr [4 ]
Cherney, David Z., I [5 ,6 ]
Chertow, Glenn M. [7 ,8 ]
Douthat, Walter [9 ]
Dwyer, Jamie P. [10 ]
Escudero, Elizabeth [11 ]
Pecoits-Filho, Roberto [12 ,13 ]
Furuland, Hans [14 ]
Gorriz, Jose Luis [15 ]
Greene, Tom [16 ]
Haller, Hermann [17 ]
Hou, Fan Fan [18 ]
Kang, Shin-Wook [19 ]
Isidto, Rey [20 ]
Khullar, Dinesh [21 ]
Mark, Patrick B. [22 ]
McMurray, John J., V [22 ]
Kashihara, Naoki [23 ]
Nowicki, Michal [24 ]
Persson, Frederik [25 ]
Correa-Rotter, Ricardo [26 ]
Rossing, Peter [25 ,27 ]
Toto, Robert D. [28 ]
Umanath, Kausik [29 ,30 ]
Van Bui, Pham [31 ]
Wittmann, Istvan [32 ,33 ]
Lindberg, Magnus [2 ]
Sjostrom, C. David [2 ]
Langkilde, Anna Maria [2 ]
Heerspink, Hiddo J. L. [34 ]
机构
[1] UCL, Dept Renal Med, London, England
[2] AstraZeneca, BioPharmaceut R&D, Late Stage Dev Cardiovasc Renal & Metab, Gothenburg, Sweden
[3] Rostov State Med Univ, Dept Nephrol, Rostov Na Donu, Russia
[4] Kharkiv Med Acad Postgrad Educ, Kharkiv, Ukraine
[5] Univ Hlth Network, Toronto Gen Hosp Res Inst, Toronto, ON, Canada
[6] Univ Toronto, Dept Med, Div Nephrol, Toronto, ON, Canada
[7] Stanford Univ, Dept Epidemiol & Populat Hlth, Sch Med, Stanford, CA USA
[8] Stanford Univ, Dept Med, Sch Med, Stanford, CA USA
[9] Hosp Privado Univ Cordoba, Dept Nephrol, Cordoba, Argentina
[10] Vanderbilt Univ, Med Ctr, Nashville, TN USA
[11] Cayetano Heredia Univ, Hosp Arzobispo Loayza, Div Nephrol, Lima, Peru
[12] Pontificia Univ Catolica Parana, Sch Med, Curitiba, Parana, Brazil
[13] Arbor Res Collaborat Hlth, Ann Arbor, MI USA
[14] Uppsala Univ Hosp, Dept Med Sci Renal Unit, Uppsala, Sweden
[15] Univ Valencia, Univ Clin Hosp, Dept Nephrol, INCLIVA, Valencia, Spain
[16] Univ Utah Hlth Sci, Study Design & Biostat Ctr, Salt Lake City, UT USA
[17] Hannover Med Sch, Hannover, Germany
[18] Southern Med Univ, Natl Clin Res Ctr Kidney Dis, Dept Med, Div Nephrol, Guangzhou, Peoples R China
[19] Yonsei Univ, Dept Internal Med, Div Nephrol, Coll Med, Seoul, South Korea
[20] Healthlink Med Dent Surg Clin & Diagnost Ctr, Iloilo, Philippines
[21] Max Super Special Hosp, Dept Nephrol & Renal Transplant Med, New Delhi, India
[22] Univ Glasgow, Inst Cardiovasc & Med Sci, Glasgow, Lanark, Scotland
[23] Kawasaki Med Sch, Dept Nephrol & Hypertens, Okayama, Japan
[24] Med Univ Lodz, Dept Nephrol Hypertens & Kidney Transplantat, Lodz, Poland
[25] Steno Diabet Ctr Copenhagen, Gentofte, Denmark
[26] Natl Med Sci & Nutr Inst Salvador Zubiran, Mexico City, DF, Mexico
[27] Univ Copenhagen, Dept Clin Med, Copenhagen, Denmark
[28] UT Southwestern Med Ctr, Dept Internal Med, Dallas, TX USA
[29] Henry Ford Hosp, Div Nephrol & Hypertens, Detroit, MI 48202 USA
[30] Wayne State Univ, Div Nephrol & Hypertens, Detroit, MI USA
[31] Pham Ngoc Thach Med Univ, Ho Chi Minh City, Vietnam
[32] Univ Pecs, Dept Med 2, Med Sch, Pecs, Hungary
[33] Univ Pecs, Nephrol Diabet Ctr, Med Sch, Pecs, Hungary
[34] Univ Med Ctr Groningen, Dept Clin Pharm & Pharmacol, Groningen, Netherlands
关键词
chronic kidney disease; dapagliflozin; randomized controlled clinical trial; sodium-glucose co-transporter-2 inhibitor; IGA NEPHROPATHY; END-POINTS; RATIONALE; FAILURE; PROGRESSION; INHIBITION; BENAZEPRIL; EFFICACY; DECLINE; DESIGN;
D O I
10.1093/ndt/gfaa234
中图分类号
R3 [基础医学]; R4 [临床医学];
学科分类号
1001 ; 1002 ; 100602 ;
摘要
Background. The Dapagliflozin and Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD; NCT03036150) trial was designed to assess the effect of the sodium-glucose co-transporter 2 (SGLT2) inhibitor dapagliflozin on kidney and cardiovascular events in participants with CKD with and without type 2 diabetes (T2D). This analysis reports the baseline characteristics of those recruited, comparing them with those enrolled in other trials. Methods. In DAPA-CKD, 4304 participants with a urinary albumin:creatinine ratio (UACR) <= 200mg/g and estimated glomerular filtration rate (eGFR) between 25 and 75mL/min/1.73m(2) were randomized to dapagliflozin 10mg once daily or placebo. Mean eGFR was 43.1mL/min/1.73m(2) and median UACR was 949 mg/g (108mg/mmol). Results. Overall, 2906 participants (68%) had a diagnosis of T2D and of these, 396 had CKD ascribed to a cause other than diabetes. The most common causes of CKD after diabetes (n = 2510) were ischaemic/hypertensive nephropathy (n = 687) and chronic glomerulonephritis (n = 695), of which immunoglobulin A nephropathy (n = 270) was the most common. A total of 4174 participants (97%) were receiving an angiotensinconverting enzyme inhibitor or angiotensin receptor blocker, 1882 (43.7%) diuretics, 229 (5.3%) mineralocorticoid receptor antagonists and 122 (2.8%) glucagon-like peptide 1 receptor agonists. In contrast to the Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE), the DAPA-CKD trial enrolled participants with CKD due to diabetes and to causes other than diabetes. The mean eGFR of participants in the DAPA-CKD trial was 13.1mL/min/1.73m(2) lower than in CREDENCE, similar to that in the Finerenone in Reducing Kidney Failure and Disease Progression in DKD (FIDELIO-DKD) trial and the Study Of diabetic Nephropathy with AtRasentan (SONAR). Conclusions. Participants with a wide range of underlying kidney diseases receiving renin-angiotensin system blocking therapy have been enrolled in the DAPA-CKD trial. The trial will examine the efficacy and safety of dapagliflozin in participants with CKD Stages 2-4 and increased albuminuria, with and without T2D.
引用
收藏
页码:1700 / 1711
页数:12
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