Active not recruitingPHASE3INTERVENTIONAL

ARTEMIS: Ravulizumab to Protect Patients With CKD From CSA-AKI and MAKE

This study, named ARTEMIS, is testing a medicine called ravulizumab. It's for adults aged 18 to 90 who have long-term kidney disease and are planning to have non-urgent heart surgery that uses a heart-lung machine. The main goal is to see if one dose of ravulizumab given into a vein can lower the chances of developing serious kidney problems, called AKI, within 90 days after the surgery. We want to understand if this medicine can protect your kidneys during and after the operation. Participants will either receive ravulizumab or a placebo (a dummy medicine) and will be closely monitored for 90 days following surgery.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Alexion Pharmaceuticals, Inc.

Enrolment target

736

Start

06 Apr 2023

Estimated completion

17 Feb 2027

Chronic Kidney Disease CKD Cardiac Disease Cardiopulmonary Bypass

What is this study about?

This research study, called ARTEMIS, is investigating a new medicine named ravulizumab. It's specifically for people who have chronic kidney disease (CKD), which means their kidneys don't work as well as they should, and who also need to have heart surgery. The type of heart surgery included in this study is non-urgent, meaning it's planned in advance, and it involves using a heart-lung machine (also known as cardiopulmonary bypass).

The main purpose of this study is to find out if ravulizumab can help protect the kidneys from developing acute kidney injury (AKI) after heart surgery. AKI is a sudden and serious problem where the kidneys stop working properly. This can lead to other complications. Researchers want to see if a single dose of ravulizumab can reduce the risk of these serious kidney problems up to 90 days after the operation.

By taking part, you would be helping doctors understand if ravulizumab could be a safe and effective way to protect the kidneys of people with CKD who are undergoing this type of heart surgery in the future. Better protection for kidneys during strenuous procedures like heart surgery could significantly improve recovery and long-term health for many patients.

Key takeaways

Tests a new medicine (ravulizumab) for kidney protection during heart surgery.
For adults with existing chronic kidney disease (CKD).
Heart surgery must involve a heart-lung machine.
Participants will receive either the medicine or a placebo (dummy drug).
Follow-up and monitoring for 90 days after surgery.
Aims to reduce the risk of serious kidney problems post-surgery.

Who may be eligible?

This study is looking for adults aged 18 to 90 years old who weigh at least 30 kg (about 4st 10lb). You need to have been diagnosed with chronic kidney disease (CKD stages 3A, 3B, or 4) for at least 90 days. You must also be planning to have specific types of non-emergency heart surgery that involves a heart-lung machine. This includes operations like multiple bypasses, heart valve replacement or repair, or a combination of these procedures.

There are also some reasons why you might not be able to join the study. For example, if you need emergency heart surgery, or if your heart surgery won't use a heart-lung machine. You also can't participate if you've recently had a solid organ or bone marrow transplant, or if you've had a very serious heart condition in the last 3 days. We also can't include you if you've had certain serious infections recently, or if you've had kidney dialysis or acute kidney problems within the last month. You must also be willing to have vaccinations against meningitis if needed.

Quick self-check

Are you between 18 and 90 years old?
Do you weigh at least 30 kg (about 4st 10lb)?
Have you been diagnosed with chronic kidney disease (CKD stages 3A, 3B, or 4) for at least 3 months?
Are you scheduled for non-emergency heart surgery (like bypass or valve repair/replacement) that will use a heart-lung machine?
Have you NOT had emergency heart surgery recently or are you NOT scheduled for one?
Have you NOT received kidney dialysis or had serious kidney problems in the last month?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would first go through a screening process to make sure it's safe and appropriate for you. If you qualify, you'll be randomly assigned to either receive the study medicine, ravulizumab, or a placebo (a dummy medicine that looks the same but contains no active drug). You wouldn't know which one you're receiving, nor would your doctors, to ensure the results are unbiased. The medicine, or placebo, will be given to you through a drip into your arm before your heart surgery.

After your surgery, the research team will monitor your health very closely. This will involve regular check-ups, blood tests, and other assessments to see how your kidneys are functioning and to check for any potential side effects. These follow-up appointments will continue for a period of 90 days after your surgery to see how you are recovering and to collect all the necessary information about the treatment's effects. The total time you'd be involved in the study from screening to the final follow-up would be approximately 90 days.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. A potential benefit of this study is that ravulizumab might help protect your kidneys during heart surgery, which could lead to a smoother recovery. However, we don't know for sure if it will help, as this is still being investigated. There could also be side effects from taking ravulizumab or other procedures involved in the study. The research team will explain all known risks and closely monitor you throughout the study for any health changes. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (162)

Research Site
Tucson, United States
Research Site
Orange, United States
Research Site
San Francisco, United States
Research Site
San Francisco, United States
Research Site
Stanford, United States
Research Site
Aurora, United States
Research Site
Weston, United States
Research Site
Atlanta, United States
Research Site
Chicago, United States
Research Site
Indianapolis, United States
Research Site
Boston, United States
Research Site
Springfield, United States

+150 more sites — see the official record for the full list.

Common questions

What is ravulizumab?

Ravulizumab is a medicine that works by blocking a part of the body's immune system called the complement system. In this study, we're trying to see if blocking this system can help protect kidneys during heart surgery.

What is a placebo?

A placebo is a 'dummy' medicine that looks exactly like the study drug but contains no active ingredients. It's used to compare the real drug's effects and ensure the study results are accurate.

Why do some people get a placebo?

Using a placebo helps researchers determine if any changes or improvements are due to the study medicine itself, rather than other factors or simply the patient's expectation of feeling better. It's a standard part of high-quality medical research.

What does 'non-emergent cardiac surgery' mean?

This means your heart surgery is planned in advance and isn't an emergency operation that needs to happen immediately.

Will my regular doctors still be in charge of my care?

Yes, your regular medical team will still be responsible for your overall care and treatment. The study team will work closely with them to ensure your care is coordinated.