Study of Roxadustat for Reducing the Incidence of Acute Kidney Injury After Coronary Artery Bypass Grafting

NCT05010460 | Terminated Phase 2

• 1 other identifier: ROXAKI
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Coronary Artery Bypass

Keywords

acute kidney injury; coronary artery bypass; Roxadustat

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• classification of acute kidney injury

  0-3 days after surgery

• renal function

  0-3 days after surgery

• new biomarkers of renal injury

  immediately after surgery and the first morning after surgery

• Cardiac Troponin Subunit I (cTnI)

  0-3 days after surgery

• brain natriuretic peptide (BNP) or N-terminal pro-BNP (NT-proBNP)

  0-3 days after surgery

Study Arms (2)

Roxadustat

EXPERIMENTAL

Roxadustat

Drug: Roxadustat

placebo

PLACEBO COMPARATOR

Placebo has the same appearance with the experimental drug (Roxadustat).

Drug: Placebo

Interventions

Roxadustat DRUG

orally 100mg every other day for 5-8 days prior to CABG

Also known as: Evrenzo

Roxadustat

Placebo DRUG

orally 100mg every other day for 5-8 days prior to CABG

placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• non-emergent CABG and planned cardiopulmonary bypass (CPB)
• eGFR\>15ml/min/1.73m2

You may not qualify if:

• pregnancy or breast feeding
• malignancy
• severe liver dysfunction
• acute kidney injury before randomization
• uncontrolled hypertension

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Beijing Hospital: collaborator

Study Sites (2)

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (5)

• 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.

  PMID: 16177006 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.

  PMID: 18178798 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.

  PMID: 30823476 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.

  PMID: 22262480 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.

  PMID: 31340089 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

roxadustat

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Yan Qin, Doctor

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

• Qi Miao, Doctor

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2021
• First Posted: August 18, 2021
• Study Start: September 30, 2021
• Primary Completion: May 20, 2025
• Study Completion: May 20, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 1 year after the end of this study
• Access Criteria: please contact the investigators through email in the time frame

Locations

CN (2)