736 Participants Needed

Ravulizumab for Kidney Damage from Heart Surgery

(ARTEMIS Trial)

Recruiting at 139 trial locations
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Overseen ByKatherine Wang
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing whether a single dose of ravulizumab, given through an IV, can help reduce kidney damage in adults with chronic kidney disease who are having planned heart surgery. The medication works by reducing inflammation and protecting the kidneys. The goal is to see if it can lower the risk of kidney problems in the months following surgery.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, you cannot participate if you have used complement inhibitors or had plasmapheresis or plasma exchange in the past year, or if you plan to use them during the study.

Is Ravulizumab safe for humans?

There is no specific safety data for Ravulizumab in the provided research articles.12345

How is the drug Ravulizumab different from other treatments for kidney damage from heart surgery?

Ravulizumab is unique because it is a long-acting drug that inhibits a specific protein (complement protein C5) involved in immune responses, allowing for less frequent dosing every 4-8 weeks compared to similar treatments. This extended dosing schedule can be more convenient for patients.678910

Are You a Good Fit for This Trial?

This trial is for adults with chronic kidney disease (CKD stages 3A, 3B, or 4) who weigh at least 30 kg and are scheduled for non-emergency heart surgery using cardiopulmonary bypass. Candidates should not have used certain kidney treatments or had infections recently and must be willing to get vaccinated against N meningitidis if needed.

Inclusion Criteria

I weigh at least 30 kilograms.
I have been diagnosed with moderate to severe kidney disease for at least 3 months.
I am scheduled for heart surgery that may include bypass or valve repair.

Exclusion Criteria

I have not used kidney replacement therapy or had acute kidney injury in the last 30 days.
I haven't used complement inhibitors or undergone plasmapheresis in the last year.
I am scheduled for a single-vessel bypass surgery without any valve procedures.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single weight-based dose of ravulizumab or placebo via intravenous infusion, 1 to 7 days prior to surgery

1 week

Surgery

Participants undergo non-emergent cardiac surgery with CPB

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on the clinical consequences of AKI (MAKE) at 90 days

90 days

What Are the Treatments Tested in This Trial?

Interventions

  • Ravulizumab
Trial Overview The ARTEMIS study is testing whether a single dose of ravulizumab given intravenously can reduce the risk of acute kidney injury after heart surgery compared to a placebo. The focus is on seeing if this treatment helps avoid major adverse kidney events within 90 days post-surgery.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RavulizumabExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Ravulizumab is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Ultomiris for:
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Approved in European Union as Ultomiris for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alexion Pharmaceuticals, Inc.

Lead Sponsor

Trials
267
Recruited
141,000+
Dr. Alberto R. Martinez profile image

Dr. Alberto R. Martinez

Alexion Pharmaceuticals, Inc.

Chief Medical Officer since 2010

MD from University of Sao Paulo

Marc Dunoyer profile image

Marc Dunoyer

Alexion Pharmaceuticals, Inc.

Chief Executive Officer since 2021

PhD in Molecular Biology

Alexion

Lead Sponsor

Trials
247
Recruited
38,600+
Marc Dunoyer profile image

Marc Dunoyer

Alexion

Chief Executive Officer since 2021

PhD in Molecular Biology, University of Brussels

Christophe Hotermans profile image

Christophe Hotermans

Alexion

Chief Medical Officer since 2021

MD, University of Leuven

Published Research Related to This Trial

Acute kidney injury (AKI) occurred in 6.7% of patients after cardiac surgery with extracorporeal circulation, highlighting a significant risk associated with this procedure.
Key independent risk factors for developing AKI included preoperative serum creatinine levels, ejection fraction, and intraoperative cardiopulmonary bypass time, suggesting that careful preoperative assessment and monitoring could help prevent AKI in these patients.
[Risk factors for acute kidney injury following 5100 cardiac surgeries with extracorporeal circulation].Ling, LG., Zeng, N., Liu, J., et al.[2009]
In a study of 1638 chronic kidney disease (CKD) patients undergoing cardiac surgery, the incidence of cardiac surgery-associated acute kidney injury (CSA-AKI) was found to be high at 50.55%, significantly impacting both renal function and overall prognosis.
Key risk factors for developing CSA-AKI included male gender, preoperative hypertension, low hemoglobin levels, and prolonged aortic clamping time, while factors like preoperative diabetes and AKI severity affected the recovery of renal function.
Risk Factors and Prognosis of Acute Kidney Injury after Cardiac Surgery in Patients with Chronic Kidney Disease.Zhang, D., Teng, J., Luo, Z., et al.[2023]
In a study analyzing 98,953 records from adult patients undergoing cardiopulmonary bypass, the use of zero-balance ultrafiltration (ZBUF) was associated with a significant 16.1% reduction in intraoperative urine output compared to patients not using ZBUF.
The findings suggest that ZBUF may negatively impact renal function during surgery, as each liter of ZBUF volume correlated with a decrease in urine output, indicating a need for further research to explore these effects in prospective studies.
Zero-Balance Ultrafiltration during Cardiopulmonary Bypass Is Associated with Decreased Urine Output.Stammers, AH., Tesdahl, EA., Mongero, LB., et al.[2021]

Citations

[Risk factors for acute kidney injury following 5100 cardiac surgeries with extracorporeal circulation]. [2009]
Risk Factors and Prognosis of Acute Kidney Injury after Cardiac Surgery in Patients with Chronic Kidney Disease. [2023]
Zero-Balance Ultrafiltration during Cardiopulmonary Bypass Is Associated with Decreased Urine Output. [2021]
Association Between Preoperative Statin Exposure and Acute Kidney Injury in Adult Patients Undergoing Cardiac Surgery. [2022]
Stratification and Risk Reduction of Perioperative Acute Kidney Injury: An Update. [2019]
Ravulizumab: A Review in Atypical Haemolytic Uraemic Syndrome. [2022]
Ravulizumab: First Global Approval. [2020]
Kidney transplant in patients with atypical hemolytic uremic syndrome in the anti-C5 era: single-center experience with tailored Eculizumab. [2022]
Characteristics, management and outcomes of atypical haemolytic uraemic syndrome in kidney transplant patients: a retrospective national study. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Report of the inefficacy of eculizumab in two cases of severe antibody-mediated rejection of renal grafts. [2022]
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