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slow enrollment and inability to reach the planned sample size within the expected timeframe
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| Name | Class |
|---|---|
| Beijing Hospital | OTHER_GOV |
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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.
Acute kidney injury is a frequent complication after coronary artery bypass grafting (CABG), with a incidence of 28-38%. Renal ischemia-reperfusion injury is the main mechanism for acute kidney injury after CABG.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Roxadustat | Experimental | Roxadustat |
|
| placebo | Placebo Comparator | Placebo has the same appearance with the experimental drug (Roxadustat). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roxadustat | Drug | orally 100mg every other day for 5-8 days prior to CABG |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| classification of acute kidney injury | classification of of acute kidney injury based on AKIN criteria | 0-3 days after surgery |
| renal function | creatinine, urea, Cystatin-C after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yan Qin, Doctor | Peking Union Medical College Hospital | Principal Investigator |
| Qi Miao, Doctor | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Beijing | Beijing Municipality | 100730 | China | ||
| Peking Union Medical College Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16177006 | Background | 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. | |
| 18178798 | Background | 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. |
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qualified researchers can request access to anonymized individual patient-level data by contacting principle investigator of this study, but this does not mean all requests will be shared by the investigators.
1 year after the end of this study
please contact the investigators through email in the time frame
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C584543 | roxadustat |
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| Placebo | Drug | orally 100mg every other day for 5-8 days prior to CABG |
|
| 0-3 days after surgery |
| new biomarkers of renal injury | serum and urine NGAL，urine TIMP2*IGFBP7 | immediately after surgery and the first morning after surgery |
| Cardiac Troponin Subunit I (cTnI) | peak plasma concentration of cTnI and area under curve (AUC) of cTnI | 0-3 days after surgery |
| brain natriuretic peptide (BNP) or N-terminal pro-BNP (NT-proBNP) | plasma concentration of BNP | 0-3 days after surgery |
| death | death during hospitalization | through study completion, an average of one month |
| length of hospital stay and ICU stay | length of hospital stay and ICU stay | through study completion, an average of one month |
| Blood infusion | amount of Red blood cells infusion after surgery | 0-3 days after surgery |
| adverse events | adverse events and severe adverse events during hospitalization | through study completion, an average of one month |
| Beijing |
| Beijing Municipality |
| 100730 |
| China |
| 30823476 | Background | 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. |
| 22262480 | Background | 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. |
| 31340089 | Background | 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. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |