Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

ARTEMIS: RAvulizumab to PRotect PaTients with Chronic Kidney DisEase (CKD) froM Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI) and Subsequent Major Adverse Kidney Events (MAKE): A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study

This study, called ARTEMIS, is investigating a new medicine called Ultomiris. It's for people who already have kidney disease and are going to have heart surgery. The main goal is to see if Ultomiris can prevent a serious type of kidney damage that can happen after heart surgery, known as acute kidney injury. Researchers are also looking at whether the medicine can reduce other serious kidney problems or even death that can occur in the 90 days after surgery. This is a crucial step to find better ways to protect vulnerable patients undergoing important heart operations.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Alexion Pharmaceuticals Inc.

Enrolment target

270

Start

15 May 2023

Prevention of cardiac surgery associated acute kidney injury

What is this study about?

Imagine you're having heart surgery, a big operation. For some people who already have kidney problems, this surgery can be risky, as it might make their kidneys worse. This is called 'acute kidney injury' (AKI), and it can sometimes lead to more serious kidney complications or even needing dialysis.

This study, called ARTEMIS, is carefully looking at a new medicine called Ultomiris. Researchers believe this medicine might help protect the kidneys during heart surgery by reducing inflammation and damage. The study is comparing Ultomiris to a 'dummy' medicine (placebo) to see if it truly makes a difference. Neither the patients nor their doctors will know who is getting the real medicine, which helps ensure the results are fair and unbiased.

The main thing the researchers want to find out is if Ultomiris can prevent 'Major Adverse Kidney Events' (MAKE) in the 90 days after heart surgery. These events include a significant worsening of kidney function, needing dialysis, or death. They will also look at other important things like how quickly people recover, how long they stay in intensive care, and their general quality of life after the surgery. The aim is to find better ways to keep kidneys healthy for people undergoing vital heart operations.

Key takeaways

The study tests a medicine (Ultomiris) to protect kidneys during heart surgery.
It's for adults who already have kidney problems.
The main aim is to prevent serious kidney complications after surgery.
Participation involves receiving the study medicine and being closely monitored for about 90 days.
Patients get careful medical attention and can withdraw at any time.

Who may be eligible?

To join this study, participants need to be adults, aged 18 years or older. Both men and women can take part. A key requirement is that you must have a pre-existing kidney condition, as the study specifically focuses on protecting kidneys during heart surgery for those who are already vulnerable.

More specific medical details will be checked by the study doctors to make sure the medicine is suitable and safe for you, and that the results of the study will be meaningful. For example, they will look at your overall health and the specifics of your kidney disease and planned heart surgery.

It's important to discuss your full medical history with the study team to see if you meet all the criteria.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a kidney condition already?
Are you scheduled to have heart surgery?
Are you willing to have regular check-ups and tests for about 3 months after surgery?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, it would involve several steps. You would receive the study medicine, either Ultomiris or a placebo, through an infusion (into your vein) around the time of your heart surgery. You wouldn't know which one you're getting.

The research team would closely monitor your health before, during, and after your surgery. This would include regular blood and urine tests to check your kidney function and overall health. You would also have check-up appointments at various times, including 30, 60, and 90 days after your surgery, to see how you are recovering and how your kidneys are doing. You might also be asked to fill out questionnaires about your quality of life. The total duration of active participation and follow-up for the main goals of the study would be around 90 days after your heart surgery.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from closer medical attention and potentially receive a medicine that could protect your kidneys, though there's also a chance you'd receive a placebo. Potential risks could include side effects from the study medicine, although Ultomiris is generally well-understood. There's always a risk with any medical procedure or new treatment. You can choose to leave the study at any time, for any reason, without it affecting your usual medical care, as your participation is completely voluntary.

Locations (8)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy
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Unverified
Germany
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Unverified
Poland
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Unverified
Spain
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Unverified
Netherlands
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Unverified
France
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Unverified
Portugal
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Unverified
Greece

Common questions

What is the main goal of this study?

To see if a medicine called Ultomiris can protect the kidneys of people with existing kidney problems who are having heart surgery.

What is 'acute kidney injury' (AKI)?

It's when your kidneys suddenly stop working as well as they should, which can sometimes happen after major surgery.

Will I know if I'm getting the real medicine or a dummy medicine?

No, neither you nor your doctors will know, which helps make the study results fair.

How long will I be involved in the study?

You'd be closely monitored for about 90 days after your heart surgery, with follow-up appointments and tests.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, and it won't affect your medical care.