Recruiting

Study on Everolimus for Preventing Rejection in Adult Kidney Transplant Patients

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 studying the effectiveness of a medication called everolimus in patients who have undergone a kidney transplant. The study is specifically looking at patients who are experiencing a type of rejection that involves the body's natural killer cells, which are part of the immune system. The purpose of the study is to see if everolimus can help prevent the kidney from losing its ability to function properly over a period of six months.

Participants in the study will receive everolimus, which is available in different forms such as tablets and oral solutions, under the brand name CERTICAN. The study will compare the effects of everolimus with those of a placebo. The treatment will be administered orally, and the maximum treatment period is six months. During the study, participants will have regular check-ups to monitor their kidney function and overall health.

The study aims to gather information on how well everolimus works in preventing further damage to the transplanted kidney. It will also look at changes in certain biological markers and the body's immune response. This research is important for improving the care and outcomes for kidney transplant patients who face challenges with rejection. The findings could help guide future treatments and improve the quality of life for those affected by kidney transplant rejection.

The research process

The trial runs in 4 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, the patient is confirmed to meet the inclusion criteria, which include being a major renal transplant patient and having specific biopsy findings.
The patient must be on at least dual immunosuppressive therapy, including an anticalcineurin and an antimetabolite.
Step 2
Medication administration
The patient begins taking everolimus, which is available in different forms such as oral solution and tablet.
The specific product names include CERTICAN 0.25 mg, 0.75 mg, 0.1 mg, and 0.5 mg, with administration being oral.
The dosage and frequency are determined by the study protocol and the patient's specific needs.
Step 3
Monitoring and evaluation
The effectiveness of everolimus is evaluated by monitoring the relative variation in Glomerular Filtration Rate (GFR) between 15 days before starting the medication and 6 months after.
Secondary evaluations include histological assessments of inflammation and chronic lesions, biological assessments of NK cell activity, and clinical assessments of proteinuria/creatininuria ratio.
Step 4
Completion of treatment
The treatment with everolimus is planned to continue for a duration that aligns with the study's objectives, with the primary endpoint being assessed at 6 months.
Patients are advised to use effective contraception for up to 8 weeks after the end of treatment.

Who can join the trial?

10 criteria

Must be a major renal transplant patient. This means the patient has received a kidney transplant.
Must have had a kidney biopsy during regular follow-up that shows certain types of inflammation in the small blood vessels of the kidney, along with moderate chronic damage, based on a specific classification system.
Must have a predictable "missing self," which means there is a mismatch between certain genetic markers in the patient and the donor.
Must be receiving at least two types of immunosuppressive therapy. This includes medications like tacrolimus or cyclosporine, and mycophenolic acid or azathioprine, which help prevent the body from rejecting the transplanted kidney.
If applicable, must use effective contraception for up to 8 weeks after finishing treatment with a medication called everolimus.
Must be affiliated with a social insurance program.
Must not have certain antibodies in their blood that react against the cells lining blood vessels, as tested by a specific blood test.
Must have at least one confirmed "missing self," meaning there is a specific genetic marker in the patient that is not present in the donor.
Must be an adult, as the study includes age ranges typically for adults.
Both male and female patients are eligible to participate.

Who cannot join the trial?

4 criteria

Patients who have not had a **kidney transplant**. A kidney transplant is a surgery where a healthy kidney from a donor is placed into someone whose kidneys are not working properly.
Patients who are not experiencing **NK-mediated rejection**. This is a type of immune response where the body's natural killer (NK) cells attack the transplanted kidney.
Patients who are under 18 years old or over 65 years old.
Patients who are part of a vulnerable population, which means they might have special needs or circumstances that require extra protection.

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Verified sites

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Centre Hospitalier Lyon Sud
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Pierre Benite, France

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Investigated drugs

Everolimus is a medication used in this clinical trial to help prevent the deterioration of kidney function in patients who have received a kidney transplant. It works by suppressing the immune system to reduce the risk of rejection, specifically targeting a type of rejection mediated by natural killer (NK) cells. This trial aims to assess how effective everolimus is in maintaining the health of the transplanted kidney over a period of six months.

Everolimus

What is already known about the treatment

Everolimus – Everolimus is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in kidney transplant patients, specifically those experiencing a type of rejection mediated by natural killer (NK) cells. The main therapeutic use of everolimus in this context is to prevent the deterioration of kidney graft function. At the molecular level, everolimus works by inhibiting a protein called mTOR, which plays a crucial role in cell growth and proliferation. This action helps to suppress the immune response that can lead to organ rejection. Everolimus is classified as an immunosuppressant medication.

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 involves the replacement of a diseased kidney with a donor kidney, which can be from a living or deceased donor. After transplantation, the body may recognize the new kidney as foreign, leading to immune-mediated rejection. This rejection can cause inflammation and damage to the transplanted kidney, potentially affecting its function. Over time, the immune response can lead to chronic changes in the kidney tissue, impacting its ability to filter waste from the blood. Monitoring and managing immune responses are crucial to maintaining the health of the transplanted kidney.