Study on the Safety of Eight Treg and Drug Combination for Patients with Chronic Kidney Failure Undergoing Transplant from a Living Donor

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What is this study about?

This clinical trial is focused on studying treatments for people with chronic kidney disease who need a kidney transplant. The main treatment being tested is called Eight Treg, which is a type of cell therapy involving special immune cells known as CD8+ regulatory T cells. These cells are taken from the patient, grown in a lab, and then given back to the patient through an infusion. The study also involves the use of standard medications that help prevent the body from rejecting the new kidney. These medications include corticosteroids, tacrolimus, and mycophenolic acid.

The purpose of the study is to evaluate the safety of the Eight Treg treatment when used alongside these standard medications. Participants will receive the Eight Treg infusion the day before their kidney transplant. The study will monitor participants for up to three months after the transplant to check for any side effects or complications. The study will also look at how the treatment affects the immune system and the new kidney over time.

Throughout the study, participants will have regular check-ups and tests to monitor their health and the function of their new kidney. These tests will include blood tests and possibly biopsies of the kidney to ensure everything is working as expected. The study aims to provide valuable information on how well the Eight Treg treatment works in helping kidney transplant patients and how safe it is to use with other medications.

1 initiation of treatment

The trial begins with the administration of the experimental drug Eight Treg through an intravenous infusion. This occurs the day before the kidney transplant procedure.

The purpose of this step is to evaluate the safety of the drug in combination with standard medications used to prevent organ rejection.

2 kidney transplant procedure

The kidney transplant is performed using a kidney from a living donor. This is a critical step in the treatment of chronic renal failure.

3 post-transplant medication regimen

After the transplant, a combination of medications is administered to prevent organ rejection and manage the immune response.

These medications include corticosteroids such as methylprednisolone hydrogen succinate (500 mg, intravenous bolus use) and prednisone (20 mg, oral use), tacrolimus (5 mg/ml, intravenous use), and mycophenolic acid (180 mg, oral use).

The medication regimen is maintained for up to three months post-transplant.

4 monitoring and follow-up

Regular follow-up visits are scheduled to monitor the patient’s health and the function of the transplanted kidney.

Blood tests and other assessments are conducted to track the immune response and detect any potential complications.

The occurrence of any dose-limiting toxicity is monitored up to three months post-transplant.

5 extended monitoring

Further monitoring is conducted up to six and twelve months post-transplant to assess long-term outcomes.

This includes analysis of graft biopsies, monitoring of infections, and evaluation of the total immunosuppressive burden.

Who Can Join the Study?

Man or woman with chronic renal failure needing a kidney transplant and approved to receive a first kidney from a living donor.
Must be part of or benefit from a social security scheme.
Must speak and understand French.
Weight should be between 50 and 100 kg.
Must have up-to-date vaccination against SARS Cov2 (the virus causing COVID-19) according to current health guidelines, with the last vaccine dose given at least 1 to 6 months before the first visit.
Must have negative results on specific tests called microlymphocytotoxicity (LCT) and flow cytometry crossmatches, which are tests to check compatibility with the donor, regardless of HLA compatibility (a genetic matching test).
Must provide signed and dated written informed consent, which means agreeing to participate after understanding the study details.
Must be at least 18 years old on the day the consent is signed.
Must be able to start the IS regimen (immunosuppressive treatment) at the time specified in the study plan.
Women of childbearing age should use an effective method of birth control, and male participants should use contraception to prevent pregnancy during the study.

Who Cannot Join the Study?

Patients who do not have chronic renal failure that requires a kidney transplant cannot participate. Chronic renal failure means the kidneys are not working well for a long time, and a transplant is needed.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are not receiving a kidney from a living donor cannot participate. A living donor is someone who is alive and donates a kidney.
Patients who are not able to receive the experimental drug “Eight Treg” or the usual drugs used after a transplant cannot participate. These usual drugs include corticosteroids (medicines that reduce inflammation), tacrolimus (a medicine that helps prevent organ rejection), and MPA (a medicine that also helps prevent organ rejection).
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes people who might need special protection or care.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Nantes	Nantes	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	02.12.2024

Trial locations

Investigated drugs:

Eight Treg is an experimental therapy involving the infusion of specially prepared immune cells called regulatory CD8+ T cells. These cells are taken from the patient, expanded outside the body, and then infused back into the patient. The goal is to help the body accept a new kidney from a living donor by regulating the immune response.

Corticosteroids are medications used to reduce inflammation and suppress the immune system. In this trial, they are part of the standard treatment to help prevent the body from rejecting the transplanted kidney.

Tacrolimus is an immunosuppressive drug that helps prevent organ rejection after a transplant. It works by decreasing the activity of the immune system to stop it from attacking the new kidney.

MPA (Mycophenolic Acid) is another immunosuppressive medication used to prevent the body from rejecting a transplanted organ. It works by inhibiting the proliferation of cells that can attack the new kidney.

Investigated diseases:

Chronic Kidney Disease – This condition involves the 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, symptoms such as fatigue, swelling in the legs and ankles, and changes in urination patterns may occur. In advanced stages, the kidneys may fail completely, necessitating dialysis or a kidney transplant. Chronic kidney disease can be caused by various factors, including diabetes, high blood pressure, and certain genetic disorders. Managing the condition involves monitoring kidney function and addressing underlying causes to slow progression.

Trial ID:

2024-513771-40-01

Protocol code:

RC24_0033

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study on the Safety of Eight Treg and Drug Combination for Patients with Chronic Kidney Failure Undergoing Transplant from a Living Donor

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?