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Study on Optimal Dose of Rabbit Anti-Human T-Lymphocyte Immunoglobulin and Mycophenolic Acid for Kidney Transplant Patients with Low Immunological Risk

Verified siteRegistered drugNo placebo
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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 patients who have received a kidney transplant and are considered to have a low risk of immune system complications. The study is investigating the use of a medication called rabbit anti-human T-lymphocyte immunoglobulin, also known as Grafalon®. This medication is given through an intravenous infusion, which means it is administered directly into a vein. The main goal of the study is to determine the best dose of Grafalon® that can help prevent complications related to a condition called CD4 T cell lymphopenia, which is a decrease in a specific type of white blood cell that is important for the immune system.

Participants in the study will receive Grafalon® for a short period, and the effects will be monitored over time. The study will look at how the medication affects the immune system, particularly the levels of different types of blood cells, and will also track any side effects or adverse events that may occur. The study aims to find a dose that is effective in preventing complications without causing significant side effects.

Throughout the study, researchers will also observe the overall health of the participants, including their kidney function and any potential infections or other health issues that may arise after the transplant. The study will help to improve understanding of how to best use Grafalon® in kidney transplant patients to support their recovery and long-term health.

The research process

The trial runs in 5 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, eligibility is confirmed based on criteria such as being 18 years or older and receiving a first kidney transplant.

  2. Step 2

    Initial treatment phase

    The treatment involves the administration of antithymocyte immunoglobulin (rabbit) through an intravenous infusion.

    The goal is to determine the optimal dose to prevent complications related to prolonged low levels of certain immune cells.

  3. Step 3

    Monitoring and assessment

    The primary outcome is measured by the relative depletion of T cells (CD3+) by more than 30% compared to the baseline at the end of the treatment on Day 4.

    Secondary outcomes include monitoring for adverse events, drug-related issues, and the pharmacokinetics of the medication.

  4. Step 4

    Follow-up period

    The follow-up includes regular assessments of immune cell counts, kidney function, and any potential infections or cardiovascular events up to one year after transplantation.

    The study also evaluates the occurrence of any cancer diagnoses and overall survival rates.

  5. Step 5

    End of study

    The study is estimated to conclude by September 30, 2026, with ongoing assessments and data collection throughout the trial period.

Who can join the trial?

4 criteria

  • Must be **18 years old** or older.
  • Must be receiving their **first kidney transplant**.
  • Both **men and women** can participate.
  • Participants should not be from a **vulnerable population**, which means they should not be in a situation where they might be easily harmed or taken advantage of.

Who cannot join the trial?

2 criteria

  • Patients who have had a renal transplant (a kidney transplant) cannot participate.
  • Patients with insufficiency renal (kidney failure or poor kidney function) are excluded.
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Investigated drugs

Grafalon is a medication used in this study to help prevent complications after a kidney transplant. It works by targeting specific immune cells called T-lymphocytes, which are part of the body's immune system. The goal is to find the best dose that effectively reduces the risk of complications without causing prolonged low levels of these immune cells.

What is already known about the treatment

Grafalon – Grafalon is administered intravenously and is used in the context of kidney transplants. It is currently being studied to determine the optimal dose for preventing complications in patients with low immunological risk. The main therapeutic indication is to prevent rejection in renal transplant recipients. Grafalon works by targeting T-lymphocytes, which are a type of white blood cell involved in immune responses, thereby reducing the risk of transplant rejection. It is classified as an immunosuppressive agent.

Investigated diseases

  • Renal Transplant

    A renal transplant involves the surgical procedure of replacing a diseased kidney with a healthy one from a donor. This procedure is typically performed when the kidneys are no longer able to function adequately, a condition known as end-stage renal disease. After the transplant, the recipient's body may recognize the new kidney as foreign, leading to potential rejection. To prevent this, patients are usually placed on immunosuppressive medications. Over time, the transplanted kidney may face complications such as infections or rejection episodes. Regular monitoring and follow-up care are essential to ensure the transplanted kidney functions properly.

  • Renal Insufficiency

    Renal insufficiency, also known as kidney failure, occurs when the kidneys are unable to filter waste products from the blood effectively. This condition can develop gradually over time, often due to chronic diseases like diabetes or hypertension. As kidney function declines, waste products and fluids can build up in the body, leading to symptoms such as fatigue, swelling, and changes in urination. In advanced stages, renal insufficiency may require dialysis or a kidney transplant. Managing underlying conditions and lifestyle changes can help slow the progression of kidney damage. Regular medical check-ups are crucial to monitor kidney function and adjust treatment as needed.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514792-17-00Protocol code2024/874Estimated enrolment18 patientsSponsorCentre Hospitalier Regional Universitaire

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