Ended Therapeutic confirmatory (Phase III) Prevention of cardiac surgery associated acute kidney injury

ARTEMIS: A Phase 3 Study of Ravulizumab to Protect Patients with Chronic Kidney Disease (CKD) from Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI) and Major Adverse Kidney Events (MAKE)

EU CTIS ID: 2022-501802-36-00

What this study is testing

To assess the efficacy of ravulizumab in reducing risk of MAKE90 following CPB

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • ≥ 18 to ≤ 90 years of age at the time of signing the informed consent.
  • Male or female; Female participants of childbearing potential and male participants must follow protocol-specified contraception guidance.
  • Body weight ≥ 30 kg at Screening.
  • Planned non-emergent cardiac surgery requiring CPB for the following procedures: Multi-vessel CABG; Valve replacement or repair; ascending aorta surgery permitted if combined with aortic valve replacement/repair; Combined CABG and valve surgery; inclusion of single-vessel CABG when combined with valve replacement/repair is permitted
  • Known or apparent CKD (by history, diagnostic results, or reasonable medical assessment made by the Investigator and recorded in the medical record) and eGFR ≥ 20 to < 60 mL/min/1.73 m2 using CKD-EPI equation by sCr or sCysC measurement, obtained by local or central laboratory during the 28 days prior to randomization
  • At risk for postsurgical kidney events as defined by a minimum STS Calculator Renal Failure Risk Score of ≥ 2.8% assessed at time of screening.

You likely can't join if

  • Emergency or salvage cardiac surgery is expected at screening or randomization, as assessed by the Investigator
  • Participation in another interventional treatment study or use of any experimental therapy within 30 days before initiation of study intervention on Day 1 in this study or within 5 half-lives of that investigational product (IP), whichever is greater, or planned participation/use during the course of the study.
  • Presence of a do-not-resuscitate order or life expectancy of < 3 months.
  • Single-vessel CABG without valve surgery is planned.
  • Pregnant, breastfeeding, or intending to conceive within 8 months after the dose of study intervention.
  • Participant is not willing to be vaccinated against N meningitidis or is unwilling to receive prophylactic treatment with appropriate antibiotics, if needed
See the full eligibility criteria
Who can join
  • ≥ 18 to ≤ 90 years of age at the time of signing the informed consent.
  • Male or female; Female participants of childbearing potential and male participants must follow protocol-specified contraception guidance.
  • Body weight ≥ 30 kg at Screening.
  • Planned non-emergent cardiac surgery requiring CPB for the following procedures: Multi-vessel CABG; Valve replacement or repair; ascending aorta surgery permitted if combined with aortic valve replacement/repair; Combined CABG and valve surgery; inclusion of single-vessel CABG when combined with valve replacement/repair is permitted
  • Known or apparent CKD (by history, diagnostic results, or reasonable medical assessment made by the Investigator and recorded in the medical record) and eGFR ≥ 20 to < 60 mL/min/1.73 m2 using CKD-EPI equation by sCr or sCysC measurement, obtained by local or central laboratory during the 28 days prior to randomization
  • At risk for postsurgical kidney events as defined by a minimum STS Calculator Renal Failure Risk Score of ≥ 2.8% assessed at time of screening.
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
What rules you out
  • Emergency or salvage cardiac surgery is expected at screening or randomization, as assessed by the Investigator
  • Participation in another interventional treatment study or use of any experimental therapy within 30 days before initiation of study intervention on Day 1 in this study or within 5 half-lives of that investigational product (IP), whichever is greater, or planned participation/use during the course of the study.
  • Presence of a do-not-resuscitate order or life expectancy of < 3 months.
  • Single-vessel CABG without valve surgery is planned.
  • Pregnant, breastfeeding, or intending to conceive within 8 months after the dose of study intervention.
  • Participant is not willing to be vaccinated against N meningitidis or is unwilling to receive prophylactic treatment with appropriate antibiotics, if needed
  • Off-pump surgery is planned (eg, surgery without CPB).
  • Any use of KRT or presence of AKI within 30 days prior to randomization (AKI defined as 1.5x increase in sCr over baseline), except transient (≤ 5 days) Stage 1 AKI after iodinated contrast exposure. Presence of AKI must be assessed within 72 hours prior to randomization.
  • Recipient of a solid organ or bone marrow transplantation.
  • Cardiogenic shock or hemodynamic instability, including use of intra-aortic balloon pump (IABP) or other temporary cardiac output support device, extracorporeal membrane oxygenation (ECMO), or left ventricular assist device within 72 hours prior to randomization.
  • Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization.
  • History of unexplained, recurrent infection.
  • Participants with history of human immunodeficiency virus (HIV) who are not on anti-retroviral therapy or if on therapy have a known detectable viral load within 1 year prior to Screening.
  • Congenital immunodeficiency.
  • Use of IVIg (eg, as acute therapy) within 4 weeks prior to dosing.
  • Known medical or psychological condition(s), including substance abuse, or risk factor that, in the opinion of the Investigator, might interfere with the participant’s full participation in the study, pose any additional risk for the participant, or confound the assessment of the participant or outcome of the study.
  • History of, or unresolved, N meningitidis infection
  • Hypersensitivity to any ingredient contained in the study intervention, including hypersensitivity to murine proteins.
  • Current malignancy (excluding local or regional prostate cancer or non-melanoma skin cancer, or indolent disease not being treated) or receiving treatment for malignancy
  • Use of any complement inhibitors, or plasmapheresis or plasma exchange within the year prior to Screening, or planned use during the course of the study.
  • Planned use of any pharmacologic agent specifically for prevention or treatment of AKI.
  • Anticipated use of KRT, extracorporeal membrane oxygenation, or temporary cardiac support devices including left ventricular assist device between randomization and surgery. Elective or pre-emptive insertion of temporary cardiac support devices (including IABP) in the absence of cardiogenic shock or hemodynamic instability.

The study team makes the final eligibility decision.

Where it's taking place

  • Japan
  • Korea, Republic of
  • Australia
  • Brazil
  • India
  • Argentina
  • Hong Kong
  • United Kingdom
  • Taiwan
  • Israel
  • China
  • United States
  • Canada
  • Turkey

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Japan; Korea, Republic of; Australia; Brazil; India; Argentina and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.