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Study on Treating Early Borderline Lesions in Low-Risk Kidney Transplant Patients with Rabbit Anti-T Lymphocyte Immunoglobulin

Registered 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-related complications. The study is investigating the treatment of early borderline lesions, which are minor changes in the kidney that can occur after a transplant. These lesions are being treated with a medication called Grafalon, which contains an active substance known as anti-T lymphocyte immunoglobulin for human use, rabbit. This medication is given through an infusion, which means it is administered directly into the bloodstream.

The purpose of the study is to determine if treating these early borderline lesions with Grafalon can prevent or slow down the progression of more serious kidney damage over time. The study will compare this treatment to the usual care that patients receive after a kidney transplant. Participants in the study will be monitored for two years to see how their kidney function changes and whether the treatment helps maintain the health of the transplanted kidney.

Throughout the study, researchers will also look at other health factors, such as blood pressure, cholesterol levels, and the occurrence of diabetes after the transplant. The goal is to understand if the treatment with Grafalon can improve overall outcomes for kidney transplant patients by reducing the risk of further complications. This study is being conducted in multiple centers across Spain, and it aims to provide valuable insights into the management of kidney transplant patients with early borderline lesions.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria. These include being over 18 years of age, having low immunological risk, and receiving a first kidney graft from a deceased or living donor.
Participants must have borderline lesions as defined by specific medical criteria and be on a treatment regimen that includes tacrolimus, mycophenolic acid, and steroids.
Step 2
Initial assessment
An initial assessment is conducted to ensure there is no clinical or subclinical immunological dysfunction and no presence of specific antibodies.
Participants provide written informed consent to participate in the study.
Step 3
Treatment administration
The treatment involves the administration of Grafalon, a solution for infusion containing anti-t lymphocyte immunoglobulin for human use, rabbit. This is given through an IV infusion.
The treatment aims to prevent or slow the progression of chronic histological lesions of the graft and deterioration of its function.
Step 4
Follow-up assessments
Follow-up assessments are conducted at 3, 6, 12, and 24 months to monitor the presence of interstitial fibrosis and tubular atrophy, as well as renal function.
Additional assessments include monitoring blood pressure, lipid levels, weight, and the rate of post-transplant diabetes or glucose intolerance.
Step 5
Final evaluation
At the end of the 24-month period, a final evaluation is conducted to assess patient and graft survival, adherence to immunosuppressive treatment, and overall health outcomes.
The study aims to determine the effectiveness of the treatment in preventing the progression of graft lesions compared to conventional clinical follow-up.

Who can join the trial?

10 criteria

Patients must be over 18 years old.
Both men and women can participate.
Patients should not have any **immunological risk**. This means their **PRA** (Panel Reactive Antibody) should be less than 20%, and they should not have **DSA** (Donor-Specific Antibodies).
Participants must have received their first kidney transplant from either a deceased or living donor.
Patients must have **BL injuries**. These are specific types of kidney injuries defined by the **Banff 2019 classification**. The injuries should have certain scores for **interstitial inflammation** and **tubulitis**, but not reach the level of more severe rejection.
Participants should be taking **Tacrolimus** along with **mycophenolic acid (MPA)** and **steroids**. These are medications used to help prevent organ rejection.
There should be no signs of **immunological dysfunction** before joining the study. This means the immune system should not be attacking the transplanted kidney.
Patients should not have developed new **anti-HLA DSA antibodies** at the time of joining the study. These antibodies can attack the transplanted kidney.
Participants must be willing and able to provide written consent to join the study.
Women who can have children must agree to use effective birth control during the study.

Who cannot join the trial?

7 criteria

Patients who are not considered low-risk in terms of their immune system.
Patients who do not have stable kidney function.
Patients who have not undergone a kidney transplant.
Patients who are not in the third month after their kidney transplant.
Patients who are not experiencing borderline lesions, which are changes in the kidney that might indicate a risk of rejection.
Patients who cannot receive treatment with rabbit polyclonal antilymphocytic globulin, a type of medication used to prevent the body from rejecting a transplanted organ.
Patients who are part of a vulnerable population, meaning they might have additional health or social challenges that make participation in the trial difficult.

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Investigated drugs

Rabbit Polyclonal Antilymphocytic Globulin is a medication used in this trial to treat early borderline lesions in kidney transplant patients. It is designed to help prevent or slow down the progression of chronic damage to the transplanted kidney. This medication works by targeting and reducing the activity of certain immune cells that can cause damage to the transplanted organ. The goal is to maintain the function of the kidney and improve the long-term success of the transplant.

Anti-T Lymphocyte Immunoglobulin For Human Use, Rabbit

What is already known about the treatment

Rabbit Polyclonal Antilymphocytic Globulin – This medication is administered intravenously and is used in the context of kidney transplantation. It is currently being studied in clinical trials to determine its effectiveness in treating early borderline lesions in low immunological risk kidney transplant patients. The main therapeutic indication is to prevent or slow the progression of chronic histological lesions of the graft and deterioration of its function. At the molecular level, it works by targeting and depleting lymphocytes, which are a type of white blood cell involved in immune responses, thereby reducing inflammation and immune-mediated damage to the transplanted organ. It is classified as an immunosuppressive agent.

Investigated diseases

Interstitial Fibrosis and Tubular Atrophy (FIAT)
This condition involves the scarring and thinning of the kidney's interstitial tissue and the atrophy of its tubular structures. Over time, these changes can lead to a gradual decline in kidney function. The progression of FIAT is often slow and may not present noticeable symptoms in the early stages. As the condition advances, it can contribute to the deterioration of the kidney's ability to filter waste from the blood effectively. Monitoring and managing the condition is crucial to prevent further damage to the kidney tissue.
Post-Transplant Diabetes Mellitus (PTDM)
This form of diabetes can develop after an organ transplant, often due to the use of immunosuppressive medications. PTDM is characterized by high blood sugar levels that occur as a result of the body's reduced ability to produce or use insulin effectively. The condition may initially present with symptoms such as increased thirst, frequent urination, and fatigue. Over time, if not managed, it can lead to complications affecting various organs and systems. Regular monitoring of blood sugar levels is essential for individuals at risk of developing PTDM.