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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05010460
Other study ID # ROXAKI
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 30, 2021
Est. completion date October 30, 2023

Study information

Verified date August 2021
Source Peking Union Medical College Hospital
Contact Sanxi Ai, Doctor
Phone +861069156874
Email sanxiai@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

Country Name City State
China Beijing Hospital Beijing Beijing
China Peking Union Medical College Hospital Beijing Beijing

Sponsors (2)

Lead Sponsor Collaborator
Peking Union Medical College Hospital Beijing Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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

Outcome

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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