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Study on Siplizumab and Rabbit Anti-Thymocyte Globulin for Preventing Rejection in New Kidney Transplant Patients

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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. The study is evaluating a new investigational medication called siplizumab, which is being compared to another medication known as anti-thymocyte globulin. These medications are being tested to see how well they can prevent the body from rejecting the new kidney after the transplant.

The purpose of the study is to assess the safety and how well patients tolerate these medications over a period of 12 months after receiving a kidney transplant. Participants will receive either siplizumab or anti-thymocyte globulin, and their health will be monitored closely throughout the study. This includes regular check-ups and tests to understand how the medications are working in the body and to ensure that they are safe for use.

During the study, participants will be randomly assigned to receive either the investigational medication or the comparison medication. Some participants may also receive a placebo. The study will involve regular visits to the clinic for monitoring and assessments, which will help researchers gather important information about the effects of these treatments on kidney transplant patients. The goal is to find the best way to help prevent kidney rejection and improve the overall success of kidney transplants.

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, the patient will be informed about the trial's purpose and procedures. Written consent is required to participate.

    The study is designed for individuals aged 18 to 70 who have received a new kidney transplant.

  2. Step 2

    Initial treatment phase

    The patient will receive an initial treatment with either siplizumab or rabbit anti-thymocyte globulin (rATG) through an intravenous infusion. This is to prevent the body from rejecting the new kidney.

    The choice between siplizumab and rATG is determined by the study's randomization process.

  3. Step 3

    Medication regimen

    The patient will take cetirizine dihydrochloride orally as a film-coated tablet to manage potential allergic reactions.

    Oral prednisolone tablets will be administered to reduce inflammation.

    The patient will also take tacrolimus and mycophenolate mofetil capsules orally to suppress the immune system and prevent organ rejection.

    In case of pain or fever, paracetamol tablets may be used.

  4. Step 4

    Monitoring and follow-up

    Regular follow-up visits will be scheduled to monitor the patient's health and the kidney's function.

    Blood tests and other assessments will be conducted to check for any adverse effects and to measure the effectiveness of the treatment.

  5. Step 5

    Study duration

    The study will last for 12 months, during which the patient's response to the treatment will be closely observed.

    The primary focus is on the safety and tolerability of the medications, as well as their impact on kidney function.

Who can join the trial?

4 criteria

  • Must be able to understand what the study involves and agree to participate by signing a form.
  • Must be a male or female between the ages of 18 and 70.
  • Must have received a new kidney transplant from a donor who was either a heart-beating deceased person, a living person not related by blood, or a living relative who is not a perfect match in terms of certain immune system markers called human leukocyte antigen (HLA).
  • Must have received a kidney that was kept cold for less than 30 hours before the transplant; using a special machine to keep the kidney cold during this time is also acceptable.

Who cannot join the trial?

11 criteria

  • Patients who have had a kidney transplant before.
  • Patients who are under 18 years old or over 65 years old.
  • Patients who are pregnant or breastfeeding.
  • Patients with a history of severe allergic reactions to similar medications.
  • Patients with active infections that require treatment.
  • Patients with a history of cancer within the last 5 years, except for certain skin cancers.
  • Patients with significant liver disease.
  • Patients with uncontrolled high blood pressure.
  • Patients who are currently participating in another clinical trial.
  • Patients with a history of drug or alcohol abuse within the last year.
  • Patients with any other medical condition that the study doctors believe would make participation unsafe.
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Investigated drugs

  • Siplizumab

    is an anti-CD2 monoclonal antibody being studied for its potential use in patients who have received a new kidney transplant. It is designed to help prevent the body from rejecting the new organ by targeting specific cells in the immune system. The study aims to evaluate how safe and tolerable siplizumab is, as well as how it behaves in the body over time.

  • Rabbit Anti-Thymocyte Globulin (rATG)

    is a medication used to suppress the immune system in patients who have received a kidney transplant. It works by targeting and reducing the number of certain immune cells that can attack the transplanted organ. This study compares the effects of rATG with those of siplizumab to determine which is more effective and safer for patients.

What is already known about the treatment

  • Siplizumab

    Siplizumab is administered as an injection and is currently being studied in clinical trials for its use in renal transplantation. It is an investigational medication, meaning it is not yet approved for general medical use but is being evaluated for its safety and effectiveness. The main therapeutic indication for siplizumab is to prevent organ rejection in patients who have received a kidney transplant. It works by targeting and binding to the CD2 protein on T-cells, which are part of the immune system, thereby reducing the immune response that can lead to organ rejection. Siplizumab is classified as a monoclonal antibody, a type of medication designed to specifically target certain proteins in the body.

  • Rabbit Anti-Thymocyte Globulin (rATG)

    Rabbit Anti-Thymocyte Globulin is administered via injection and is used in the context of renal transplantation. It is an established medication in the medical field, commonly used to prevent and treat organ rejection in transplant recipients. The main therapeutic indication for rATG is to suppress the immune system to prevent it from attacking the transplanted organ. It works by depleting T-cells, which are a type of white blood cell involved in the immune response. rATG is classified as an immunosuppressive agent, which helps to reduce the activity of the immune system.

Investigated diseases

Renal Transplantation – Renal transplantation is a medical procedure where a healthy kidney from a donor is placed into a person whose kidneys are no longer functioning properly. This condition arises when the kidneys lose their ability to filter waste and excess fluids from the blood, leading to a buildup of harmful substances in the body. The progression involves the recipient's body potentially recognizing the new kidney as foreign, which can lead to immune responses that may damage the transplanted organ. Over time, the body may adapt to the new kidney, but there is a risk of rejection, which requires careful monitoring and management. The success of the transplant depends on various factors, including the compatibility of the donor kidney and the recipient's immune response.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507895-36-00Protocol codeTCD601B101Estimated enrolment46 patientsSponsorItb-Med AB

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).