Study of Roxadustat for Reducing the Incidence of Acute Kidney Injury After Coronary Artery Bypass Grafting
NCT ID: NCT05010460
Last Updated: 2025-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
98 participants
INTERVENTIONAL
2021-09-30
2025-05-20
Brief Summary
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This study aims to evaluate the efficacy of administration of Roxadustat before surgery in the prevention of acute kidney injury after CABG.
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Detailed Description
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Roxadustat is a kind of 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. This is a multicenter, randomized, double-blind, placebo-controlled study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Roxadustat
Roxadustat
Roxadustat
orally 100mg every other day for 5-8 days prior to CABG
placebo
Placebo has the same appearance with the experimental drug (Roxadustat).
Placebo
orally 100mg every other day for 5-8 days prior to CABG
Interventions
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Roxadustat
orally 100mg every other day for 5-8 days prior to CABG
Placebo
orally 100mg every other day for 5-8 days prior to CABG
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* non-emergent CABG and planned cardiopulmonary bypass (CPB)
* eGFR\>15ml/min/1.73m2
Exclusion Criteria
* malignancy
* severe liver dysfunction
* acute kidney injury before randomization
* uncontrolled hypertension
18 Years
80 Years
ALL
No
Sponsors
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Beijing Hospital
OTHER_GOV
Peking Union Medical College Hospital
OTHER
Responsible Party
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Principal Investigators
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Yan Qin, Doctor
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Qi Miao, Doctor
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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Beijing Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Countries
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References
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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. doi: 10.1681/ASN.2004090740. Epub 2005 Sep 21.
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.
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):207. doi: 10.3390/cells8030207.
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.
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.
Other Identifiers
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ROXAKI
Identifier Type: -
Identifier Source: org_study_id
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