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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 trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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. Step 7

    Day 28 follow-up

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

  8. Step 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 trial?

10 criteria

  • 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 trial?

5 criteria

  • 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
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Investigated drugs

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.

What is already known about the treatment

Rasburicase – Rasburicase is a medication given as an injection into a vein that helps lower high levels of uric acid in the blood by breaking it down into a substance that is easier for the body to eliminate. It is approved for treating dangerously high uric acid levels, particularly in cancer patients undergoing chemotherapy, and is currently being studied in clinical trials to see if it can help protect kidney function in patients with sepsis who have elevated uric acid levels. The drug works by acting as an enzyme that converts uric acid into a more water-soluble compound, making it simpler for the kidneys to remove it from the body. Rasburicase belongs to a class of medications called uric acid-lowering enzymes and is specifically designed to rapidly reduce uric acid when levels become critically high.

Investigated diseases

  • 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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508071-36-00Protocol codeAPHP191099Estimated enrolment240 patientsSponsorAssistance Publique Hopitaux De Paris

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