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Study Comparing Anakinra and Prednisone for Treating Gout Flare in Patients with Advanced Kidney Disease or Kidney Transplant

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What is this trial about?

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

This clinical trial is focused on studying the effectiveness of two treatments for managing gout flare-ups in patients who have chronic kidney disease at stages 3b, 4, or 5, or who have undergone a kidney transplant. The trial involves two medications: anakinra, which is given as an injection, and prednisone, which is taken as a tablet. Anakinra works by blocking a protein in the body that can cause inflammation, while prednisone is a type of steroid that helps reduce inflammation and pain.

The purpose of the study is to determine if anakinra is more effective than prednisone in treating gout attacks in these patients. Participants in the study will receive either anakinra or prednisone, and some may receive a placebo, which looks like the real medication but does not contain any active ingredients. The study will last for a short period, during which participants will be monitored for changes in their symptoms, particularly pain levels, and any side effects they might experience.

Throughout the study, researchers will compare how quickly and effectively each treatment reduces pain and resolves the gout attacks. They will also observe any side effects, such as reactions at the injection site for anakinra or changes in blood cell counts. The study aims to provide valuable information on the best treatment options for managing gout in patients with chronic kidney disease or those who have had a kidney transplant.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be required to sign an informed consent form. This form confirms the patient's understanding and agreement to participate in the clinical trial.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility. This includes verifying age, medical history, and current health status, particularly focusing on chronic kidney disease and gout symptoms.

  3. Step 3

    Randomization

    The patient will be randomly assigned to one of two groups. One group will receive the medication anakinra, and the other will receive prednisone. This process is double-blind, meaning neither the patient nor the researchers will know which treatment the patient is receiving.

  4. Step 4

    Treatment administration

    If assigned to the anakinra group, the patient will receive a subcutaneous injection of Kineret 100 mg/0.67 ml solution. If assigned to the prednisone group, the patient will take CORTANCYL 20 mg tablets orally. The frequency and duration of administration will be determined by the study protocol.

  5. Step 5

    Monitoring and follow-up

    The patient will be monitored regularly to assess the effectiveness of the treatment and any side effects. This includes measuring changes in pain levels and checking for any adverse reactions to the medication.

  6. Step 6

    Evaluation of results

    The primary evaluation will focus on the change in pain levels from the start of the treatment to three days after initiation or upon discharge if earlier. Secondary evaluations will include the speed of resolution of gout attacks, treatment response time, and any relapses during the study period.

  7. Step 7

    Completion of the study

    Upon completion of the study, the patient will have a final assessment to evaluate overall health and any long-term effects of the treatment. The results will contribute to understanding the effectiveness and safety of the treatments for gout in patients with chronic kidney disease.

Who can join the trial?

17 criteria

  • Must be an adult over 18 years old.
  • Must have a gout attack confirmed by:
    • Finding urate crystals in joint fluid or tophus, or
    • Using ultrasound on the affected joint, or
    • Meeting the Nijmegen criteria with a score greater than 8 out of 13, which includes:
      • Being a man (2 points)
      • Having had a previous gout attack (2 points)
      • Injury to the big toe joint (2.5 points)
      • Symptoms appearing in less than 24 hours (0.5 points)
      • Redness (1 point)
      • Having high blood pressure or heart diseases (1.5 points)
      • High blood uric acid levels during the attack (3.5 points)
      • Must have a persistent gout attack.
      • Must have a pain score of more than 4 out of 10 on a pain scale.
      • Must have chronic kidney disease stages 3b, 4, or 5, or have had a kidney transplant, or be on dialysis.
      • Must be affiliated with the French social security system or CMU.
      • Must sign an informed, free, and written consent to participate in the study.
      • For premenopausal women, must have a negative pregnancy test and use effective contraception, such as:
        • Hormonal contraception (Progesterone or combined Progesterone and estrogen taken orally, vaginally, under the skin, or as an implant)
        • Hormonal or mechanical intrauterine device (IUD)

Who cannot join the trial?

5 criteria

  • Patients who are under 18 years old cannot participate.
  • Patients who do not have **renal failure** (a condition where the kidneys do not work properly) in stages 3b, 4, or 5 cannot participate.
  • Patients who have not had a **renal transplantation** (a surgery to place a healthy kidney from a donor into a person whose kidneys no longer function properly) cannot participate.
  • Patients who are not on **dialysis** (a treatment that does some of the things done by healthy kidneys, like removing waste, salt, and extra water to prevent them from building up in the body) cannot participate.
  • Patients who do not have an untreated **gout attack** (a sudden and severe pain in the joints, often in the big toe, caused by high levels of uric acid in the blood) cannot participate.
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Investigated drugs

  • Anakinra

    is a medication used in this trial to help reduce inflammation and pain caused by gout attacks. It works by blocking a specific protein in the body called interleukin-1, which is involved in causing inflammation. By blocking this protein, anakinra can help decrease the swelling and discomfort associated with gout flares, especially in patients who have chronic kidney disease or have had a kidney transplant.

  • Prednisone

    is another medication used in this trial, which is a type of steroid. It helps to reduce inflammation and suppress the immune system. In the context of this trial, prednisone is used to manage the symptoms of gout attacks, such as pain and swelling, in patients with chronic kidney disease or those who have undergone kidney transplantation. Prednisone works by decreasing the body's immune response, which can help alleviate the symptoms of a gout flare.

What is already known about the treatment

Anakinra – Anakinra is administered as an injection under the skin and is currently being studied for its effectiveness in treating gout attacks in people with chronic kidney disease or those who have had a kidney transplant. It is known in medical literature as a recombinant form of an interleukin-1 receptor antagonist, which means it works by blocking the action of a protein called interleukin-1 that causes inflammation and pain. Anakinra is classified as an anti-inflammatory medication and is being compared to prednisone, a commonly used steroid, to see which is more effective for this condition.

Investigated diseases

  • Chronic Kidney Disease

    Chronic Kidney Disease (CKD) is a condition characterized by a gradual loss of kidney function over time. The kidneys become less effective at filtering waste and excess fluids from the blood, which can lead to a buildup of harmful substances in the body. As the disease progresses, individuals may experience symptoms such as fatigue, swelling in the legs and ankles, and changes in urination patterns. CKD is classified into stages based on the severity of kidney damage, with stages 3b, 4, and 5 indicating more advanced disease. In the later stages, the kidneys may fail to function adequately, necessitating dialysis or kidney transplantation. The progression of CKD can vary, and it often requires ongoing monitoring and management.

  • Gout

    Gout is a form of arthritis characterized by sudden, severe attacks of pain, redness, and swelling in the joints, often affecting the big toe. It occurs due to the accumulation of uric acid crystals in the joints, which can cause inflammation and intense discomfort. These attacks can happen unexpectedly and may last for days or weeks. Over time, repeated gout attacks can lead to joint damage and decreased mobility. The condition is often associated with high levels of uric acid in the blood, which can be influenced by diet, genetics, and other health conditions. Managing uric acid levels is crucial to preventing future attacks and complications.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514347-28-00Protocol codeAPHP180560Estimated enrolment234 patientsSponsorAssistance Publique Hopitaux De Paris

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