Testing rasburicase for preventing and treating kidney problems in adult patients with sepsis and high uric acid levels

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What is this study about?

This study examines sepsis, a serious condition that occurs when the body has an extreme response to an infection, which can lead to tissue damage, organ failure, and death. The study focuses on patients with sepsis who have high levels of uric acid in their blood, which is a substance that the body produces when it breaks down certain chemicals. High uric acid levels during sepsis may contribute to kidney problems. The treatment being tested is rasburicase, a medication that breaks down uric acid in the body, compared to placebo. Rasburicase is given as an infusion, which means it is administered slowly through a vein.

The purpose of the study is to determine whether rasburicase can prevent or reduce kidney damage in patients with sepsis who have elevated uric acid levels. The researchers want to see if lowering uric acid levels with this medication can protect kidney function or help it recover better during sepsis. Kidney problems are common in patients with sepsis and can be serious, so finding ways to protect the kidneys during this illness is important.

Patients who participate in this study will be in an intensive care unit and will receive either rasburicase or placebo within 48 hours of being diagnosed with sepsis. The study will monitor kidney function over the first seven days after treatment to see if there is any worsening of kidney damage or if existing kidney injury improves. Additional measurements will be taken to track markers of kidney injury in blood and urine, as well as other indicators of how the body is responding to the infection. The study will also follow patients for up to 90 days to assess longer-term outcomes.

1 Enrollment and initial assessment

Upon joining the study, your informed consent form will be signed after receiving information about the trial.

A rapid diagnostic test for G6PD deficiency (a genetic condition affecting red blood cells) will be performed to ensure it is negative.

Your uric acid level will be measured to confirm it is at or above 200 micromoles per liter.

Your medical history and current condition will be assessed to confirm the diagnosis of sepsis (a serious condition caused by the body’s response to infection) within 48 hours of diagnosis.

If you are a woman of childbearing age, confirmation of effective contraception use will be required, which must continue throughout treatment and for 1 month after treatment ends.

2 Treatment administration

You will receive either rasburicase or placebo (an inactive substance) through an intravenous infusion (a slow injection into a vein).

The study medication will be administered as Fasturtec 1.5 mg/ml powder and solvent for concentrate for solution for infusion, or a matching placebo.

Neither you nor your medical team will know which treatment you are receiving, as this is a double-blind study.

The treatment is administered during your hospitalization in the intensive care unit.

3 Day 0 assessments

Blood and urine samples will be collected to measure kidney injury markers including N-GAL, Pro-enkephalin, and IL-18 (substances that indicate kidney stress or damage).

4 Day 1 assessments

Blood samples will be taken to measure your white blood cell count and levels of inflammatory markers (substances that show how your body is responding to infection), including TNFα, IL-1, IL-6, IL-8, and IL-10.

5 Day 3 assessments

Blood and urine samples will be collected again to measure kidney injury markers (N-GAL, Pro-enkephalin, IL-18).

Blood samples will be taken to measure white blood cell count and inflammatory markers (TNFα, IL-1, IL-6, IL-8, IL-10).

6 Day 7 assessments

Blood and urine samples will be collected to measure kidney injury markers (N-GAL, Pro-enkephalin, IL-18).

Blood samples will be taken to measure white blood cell count and inflammatory markers (TNFα, IL-1, IL-6, IL-8, IL-10).

Your kidney function will be evaluated to determine if there has been onset of acute kidney injury (sudden decrease in kidney function) or progression of existing kidney injury according to KDIGO criteria (standardized medical guidelines for assessing kidney function).

Your SOFA score (a measurement system that evaluates how well your organs are functioning) will be assessed. This score will be monitored throughout the first 7 days to determine the maximum value reached.

7 Day 28 follow-up

Your health status will be assessed at 28 days after enrollment.

8 Day 90 follow-up

Your health status will be assessed at 90 days after enrollment to complete the study follow-up period.

Who Can Join the Study?

You must be 18 years old or older
You must have a diagnosis of sepsis, which is a serious condition where your body has an extreme response to an infection, causing widespread inflammation
Your sepsis must have been diagnosed within the last 48 hours
You must have been admitted to an intensive care unit, which is a special hospital department for patients who need close monitoring and advanced medical support
Your SOFA score must have increased by 2 or more points. This is a scoring system doctors use to measure how well your organs are working
Your blood test must show a uric acid level of 200 µmol/L or higher. Uric acid is a waste product normally removed by your kidneys
You must have a negative test for G6PD deficiency. G6PD is an enzyme in your blood cells, and lacking it can cause problems with certain medications
You must be enrolled in a social security scheme
You or your legal representative must sign an informed consent form, which means you agree to participate after understanding the study details
If you are a woman who can become pregnant, you must use effective birth control during the treatment and for 1 month after the treatment ends

Who Cannot Join the Study?

Patients with G6PD deficiency, which is a condition where the body lacks an enzyme that helps red blood cells work properly
Patients who were diagnosed with sepsis (a serious blood infection) more than 48 hours ago
Patients with uric acid levels below 200 µmol/L in their blood (uric acid is a waste product normally removed by the kidneys)
Patients who are not hospitalized in intensive care, which is a special hospital unit for critically ill patients requiring close monitoring
Children and adolescents under 18 years of age

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Centre Hospitalier Victor Dupouy	Argenteuil	France
Ramsay Generale De Sante	Bayonne	France
Hopital Beaujon	Clichy	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	01.12.2025

Trial locations

Investigated drugs:

Rasburicase

Rasburicase is a medication that helps lower high levels of uric acid in the blood. Uric acid is a waste product that the body normally removes through the kidneys. In this trial, rasburicase is being tested to see if it can help protect kidney function in patients who have sepsis (a serious infection affecting the whole body) and high uric acid levels. The medication works by breaking down uric acid into substances that are easier for the body to eliminate.

Investigated diseases:

Sepsis

Sepsis – Sepsis is a serious condition that occurs when the body’s response to an infection becomes harmful to its own tissues and organs. It develops when chemicals released into the bloodstream to fight an infection trigger widespread inflammation throughout the body. This inflammation can lead to a cascade of changes that damage multiple organ systems. As sepsis progresses, it can cause blood pressure to drop and organs to begin failing. The condition can affect anyone but is more common in people with weakened immune systems or serious underlying illnesses. Without proper care, sepsis can rapidly worsen and lead to organ dysfunction.

Acute Kidney Injury – Acute kidney injury is a sudden episode of kidney failure or kidney damage that happens within a few hours or days. The kidneys lose their ability to filter waste products from the blood, causing dangerous levels of waste to accumulate in the body. This condition can occur due to various factors including severe infections, reduced blood flow to the kidneys, or direct damage to kidney tissue. As the condition progresses, fluid can build up in the body and the balance of important minerals and salts becomes disrupted. The severity of acute kidney injury is classified into different stages based on changes in kidney function and urine output. Many people with this condition may not notice symptoms initially, but it can be detected through blood and urine tests.

Trial ID:

2023-508071-36-00

Protocol code:

APHP191099

Trial Phase:

Therapeutic confirmatory (Phase III)

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Testing rasburicase for preventing and treating kidney problems in adult patients with sepsis and high uric acid levels

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?