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Coronary Artery BypassPhase 2NCT05010460

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

A Phase 2 study testing Roxadustat in people with Coronary Artery Bypass, run by Peking Union Medical College Hospital at 2 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Coronary Artery Bypass
What is being tested?
Roxadustat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
98 participants
Where
2 sitesChina
Study dates
30 Sep 2021to 20 May 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-80 years old
  • non-emergent CABG and planned cardiopulmonary bypass (CPB)
  • eGFR>15ml/min/1.73m2

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

Other trials in China

About this study

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.

Read the detailed 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.

Being tested
Roxadustat, Placebo
Keywords
acute kidney injury, coronary artery bypass, Roxadustat
Medical subject headings
Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RoxadustatDrug

    Also called Evrenzo

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

  • PlaceboDrug

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

Study groups in NCT05010460
Study groupRoleWhat they receive
RoxadustatExperimentalRoxadustat
Receives: Drug: Roxadustat
placeboPlacebo comparatorPlacebo has the same appearance with the experimental drug (Roxadustat).
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 0-48 hours after surgery

Secondary outcomes (9)

  1. classification of acute kidney injury

    classification of of acute kidney injury based on AKIN criteria

    Measured: 0-3 days after surgery

  2. renal function

    creatinine, urea, Cystatin-C after surgery

    Measured: 0-3 days after surgery

  3. new biomarkers of renal injury

    serum and urine NGAL，urine TIMP2*IGFBP7

    Measured: immediately after surgery and the first morning after surgery

  4. Cardiac Troponin Subunit I (cTnI)

    peak plasma concentration of cTnI and area under curve (AUC) of cTnI

    Measured: 0-3 days after surgery

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

    plasma concentration of BNP

    Measured: 0-3 days after surgery

  6. death

    death during hospitalization

    Measured: through study completion, an average of one month

  7. length of hospital stay and ICU stay

    length of hospital stay and ICU stay

    Measured: through study completion, an average of one month

  8. Blood infusion

    amount of Red blood cells infusion after surgery

    Measured: 0-3 days after surgery

  9. adverse events

    adverse events and severe adverse events during hospitalization

    Measured: through study completion, an average of one month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2021
  2. Study start30 Sep 2021
  3. Primary completion20 May 2025
  4. Study completion20 May 2025

Why it stopped: slow enrollment and inability to reach the planned sample size within the expected timeframe

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05010460
Sponsor's protocol ID
ROXAKI
Status last verified
Dec 2025
First submitted
7 Aug 2021
Last updated
9 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 16177006

  • 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.

    PubMed 18178798

  • 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.

    PubMed 30823476

  • 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.

    PubMed 22262480

  • 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.

    PubMed 31340089

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Roxadustat in people with Coronary Artery Bypass, run by Peking Union Medical College Hospital at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: slow enrollment and inability to reach the planned sample size within the expected timeframe). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

acute kidney injury (time frame: 0-48 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05010460, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.

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