AuthorisedTherapeutic confirmatory (Phase III)Interventional

RASBU-SEPSIS Study: Effects of rasburicase on renal function during sepsis – a randomized, placebo-controlled, double-blind trial

This study, called RASBU-SEPSIS, is investigating a medicine called rasburicase for adults who are very unwell with sepsis and are in intensive care. Sepsis is a serious infection that can sometimes harm the kidneys. The study is trying to find out if giving rasburicase can help prevent further kidney problems or stop existing kidney issues from getting worse within the first seven days of treatment. Participants will either receive rasburicase or a dummy medicine (placebo) to fairly compare their effects. This is a large-scale study, meaning it's in its final stages before a medicine might be widely used, if proven safe and effective. The main aim is to protect kidney function during this critical time.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

240

Start

24 Nov 2025

Patients hospitalised in intensive care diagnosed with sepsis less than 48 hours ago uric acid level ≥200µmol/L adults negative G6PD deficiency

What is this study about?

Sepsis is a very serious condition where your body's response to an infection damages its own tissues and organs. If you're in intensive care with sepsis, your body is working incredibly hard to fight the infection. Sometimes, this can put a lot of strain on your kidneys, which are vital for filtering waste from your blood. When kidneys struggle, it's called acute kidney injury (AKI), and it can make you even sicker.

This study, called RASBU-SEPSIS, is looking into whether a medicine called rasburicase can help protect your kidneys during sepsis. We hope it might prevent new kidney problems or stop existing kidney issues from getting worse in the first week. Rasburicase is already used for other conditions, but we want to see if it can be helpful for sepsis patients.

To make sure the results are fair, some patients will receive rasburicase, and others will receive a placebo – a dummy medicine that looks the same but has no active ingredient. Neither you nor your doctors will know which you are receiving. This helps us truly understand if rasburicase is making a difference. The results from this study could be very important for improving how we care for people with sepsis in the future.

Key takeaways

The study is for adults in intensive care with sepsis.
It's exploring a medicine called rasburicase to protect kidneys.
Some patients will get the medicine, others a dummy treatment.
Your kidney health and other markers will be closely monitored.
The main goal is to see if kidney problems can be prevented or improved.
Results could help improve future sepsis care.

Who may be eligible?

This study is looking for adult patients who are currently in intensive care because they have sepsis. Sepsis is a very serious infection, and to be considered for this study, you would need to have been diagnosed with it within the last two days.

Another important factor is your uric acid level. We are specifically looking for patients whose uric acid levels in their blood are above a certain amount. We also need to make sure you don't have a rare inherited condition called G6PD deficiency, as this medicine might not be suitable for you if you do.

If you fit these general criteria, your medical team will be able to tell you if this study might be an option for you.

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 an adult (18 years or older)?
Are you currently in intensive care with a sepsis diagnosis?
Was your sepsis diagnosed within the last 48 hours?
Do you have high uric acid levels in your blood?
Do you NOT have a rare condition called G6PD deficiency?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will either receive the study medicine, rasburicase, or a placebo (a dummy medicine) through a drip, just like other medicines you might be getting in intensive care. Neither you nor your doctors will know which one you are receiving.

Your medical team will closely monitor your health, particularly your kidney function, over the first seven days. This will involve regular blood and urine tests. We will also monitor other important markers in your blood and urine at specific times, for example, on day 1, day 3, and day 7, to see how your body is responding. After the initial seven days, we will continue to follow your progress, importantly checking your health status and whether you are still alive at 28 days and 90 days after joining the study. The total length of your direct involvement in terms of receiving the study medicine and close monitoring is mostly within the first week, with longer-term check-ins on your well-being.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that rasburicase could help protect your kidneys during sepsis, which might improve your overall recovery. However, as with all medicines, there could be side effects or risks, which your medical team will discuss with you. You will be closely monitored, and your well-being is always the top priority. Remember that taking part in a study is completely voluntary, and you have the right to withdraw at any time without it affecting your medical care.

Locations (1)

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

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Unverified
France

Common questions

What is sepsis?

Sepsis is a life-threatening condition that happens when your body's immune system overreacts to an infection and starts to damage your own tissues and organs.

What are kidneys and why are they important?

Kidneys are two bean-shaped organs that filter waste products from your blood and help maintain your body's water and salt balance. They are essential for keeping you healthy.

What is rasburicase?

Rasburicase is a medicine that helps lower high levels of a substance called uric acid in the blood.

What does 'placebo-controlled' mean?

It means some people will get the active medicine, and others will get a 'dummy' medicine (placebo) that looks the same. This helps us see if the medicine really works.

Will I know if I'm getting the active medicine or the placebo?

No, this is a 'double-blind' study, meaning neither you, your doctors, nor the researchers will know who is receiving which until the study is over. This ensures the results are as fair as possible.