Coronary Artery Bypass Clinical Trial
Official title:
Roxadustat Reduces the Incidence of Acute Kidney Injury After Coronary Artery Bypass Grafting: a Multicenter, Randomized, Double-blind, Placebo-controlled Study
Acute kidney injury is a frequent complication after coronary artery bypass grafting (CABG). Roxadustat is a prolyl hydroxylase inhibitor (PHI) which can stabilize hypoxia-inducible factor (HIF) and improve the hypoxic tolerance of tissues. Roxadustat has shown effect in reducing acute kidney injury in animal studies. This study aims to evaluate the efficacy of administration of Roxadustat before surgery in the prevention of acute kidney injury after CABG.
Status | Recruiting |
Enrollment | 318 |
Est. completion date | October 30, 2023 |
Est. primary completion date | August 20, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - 18-80 years old - non-emergent CABG and planned cardiopulmonary bypass (CPB) - eGFR>15ml/min/1.73m2 Exclusion Criteria: - pregnancy or breast feeding - malignancy - severe liver dysfunction - acute kidney injury before randomization - uncontrolled hypertension |
Country | Name | City | State |
---|---|---|---|
China | Beijing Hospital | Beijing | Beijing |
China | Peking Union Medical College Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital | Beijing Hospital |
China,
Chen N, Hao C, Peng X, Lin H, Yin A, Hao L, Tao Y, Liang X, Liu Z, Xing C, Chen J, Luo L, Zuo L, Liao Y, Liu BC, Leong R, Wang C, Liu C, Neff T, Szczech L, Yu KP. Roxadustat for Anemia in Patients with Kidney Disease Not Receiving Dialysis. N Engl J Med. 2019 Sep 12;381(11):1001-1010. doi: 10.1056/NEJMoa1813599. Epub 2019 Jul 24. — View Citation
Chertow GM, Burdick E, Honour M, Bonventre JV, Bates DW. Acute kidney injury, mortality, length of stay, and costs in hospitalized patients. J Am Soc Nephrol. 2005 Nov;16(11):3365-70. Epub 2005 Sep 21. — View Citation
Hill P, Shukla D, Tran MG, Aragones J, Cook HT, Carmeliet P, Maxwell PH. Inhibition of hypoxia inducible factor hydroxylases protects against renal ischemia-reperfusion injury. J Am Soc Nephrol. 2008 Jan;19(1):39-46. doi: 10.1681/ASN.2006090998. — View Citation
Kapitsinou PP, Jaffe J, Michael M, Swan CE, Duffy KJ, Erickson-Miller CL, Haase VH. Preischemic targeting of HIF prolyl hydroxylation inhibits fibrosis associated with acute kidney injury. Am J Physiol Renal Physiol. 2012 May 1;302(9):F1172-9. doi: 10.1152/ajprenal.00667.2011. Epub 2012 Jan 18. — View Citation
Shu S, Wang Y, Zheng M, Liu Z, Cai J, Tang C, Dong Z. Hypoxia and Hypoxia-Inducible Factors in Kidney Injury and Repair. Cells. 2019 Feb 28;8(3). pii: E207. doi: 10.3390/cells8030207. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | acute kidney injury | elevation of serum creatinine =0.3mg/dl(26.5µmol/L)or = 1.5 times baseline levels within 48 hours post surgery | 0-48 hours after surgery | |
Secondary | classification of acute kidney injury | classification of of acute kidney injury based on AKIN criteria | 0-3 days after surgery | |
Secondary | renal function | creatinine, urea, Cystatin-C after surgery | 0-3 days after surgery | |
Secondary | new biomarkers of renal injury | serum and urine NGAL,urine TIMP2*IGFBP7 | immediately after surgery and the first morning after surgery | |
Secondary | Cardiac Troponin Subunit I (cTnI) | peak plasma concentration of cTnI and area under curve (AUC) of cTnI | 0-3 days after surgery | |
Secondary | brain natriuretic peptide (BNP) or N-terminal pro-BNP (NT-proBNP) | plasma concentration of BNP | 0-3 days after surgery | |
Secondary | death | death during hospitalization | through study completion, an average of one month | |
Secondary | length of hospital stay and ICU stay | length of hospital stay and ICU stay | through study completion, an average of one month | |
Secondary | Blood infusion | amount of Red blood cells infusion after surgery | 0-3 days after surgery | |
Secondary | adverse events | adverse events and severe adverse events during hospitalization | through study completion, an average of one month |
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