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Study on Optimizing Immunosuppressive Treatment for Living Donor Kidney Transplant Patients Using Prednisone, Basiliximab, and Tacrolimus Monohydrate

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 focuses on patients who have received a kidney transplant from a living donor. The study aims to evaluate the effectiveness of tailoring immunosuppressive treatment based on specific biomarkers, which are indicators in the body that can help predict how the immune system will react. The goal is to optimize the treatment to prevent complications such as loss of kidney function, rejection of the transplanted kidney, and the development of antibodies against the donor kidney.

The study involves several medications used to suppress the immune system and prevent rejection of the transplanted kidney. These include Prednisone, a type of steroid taken orally; Basiliximab, also known as CHI-621, which is given through an intravenous injection; Tacrolimus, taken as a capsule; Mycophenolate Mofetil, also in capsule form; and Methylprednisolone, administered as an injection. Another medication used is Rabbit Anti-Human Thymocyte Immunoglobulin, which is given through an infusion. Some participants may receive a placebo instead of one of these medications.

Participants in the study will be randomly assigned to receive either the standard treatment or a personalized treatment plan based on their immunological risk, as determined by the biomarkers. The study will follow participants for two years to monitor outcomes such as kidney function, rejection episodes, and the development of antibodies. The study will also track other health aspects, including infections, metabolic disorders like diabetes, and any serious side effects related to the treatment. The aim is to improve the long-term success of kidney transplants by using a more individualized approach to immunosuppressive therapy.

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
Initiation of treatment
Upon joining the study, the patient will begin treatment with several medications. These include prednisone, taken orally in the form of a tablet, and tacrolimus, also taken orally as a hard capsule.
The patient will receive basiliximab intravenously as a solution for injection or infusion. This medication is administered to help prevent the body from rejecting the transplanted kidney.
Step 2
Additional medication administration
The patient will also take mycophenolate mofetil orally in the form of hard capsules. This medication helps suppress the immune system to prevent rejection of the transplanted kidney.
In certain situations, methylprednisolone may be administered intravenously as a solution for injection. This is used to manage inflammation and immune response.
Step 3
Immunosuppressive therapy
The patient will receive rabbit anti-human thymocyte immunoglobulin intravenously as a solution for infusion. This is part of the immunosuppressive therapy to reduce the risk of kidney rejection.
The treatment plan is individualized based on specific biomarkers to optimize the immunosuppressive regimen.
Step 4
Monitoring and follow-up
Throughout the trial, the patient will be monitored for any signs of kidney rejection, changes in kidney function, and potential side effects of the medications.
Regular follow-up visits will be scheduled to assess the patient's health and the effectiveness of the treatment.
Step 5
Completion of trial
The trial is expected to last until March 31, 2027. During this period, the patient will continue to receive the prescribed medications and attend follow-up appointments.
At the end of the trial, the patient's overall health and kidney function will be evaluated to determine the success of the treatment.

Who can join the trial?

8 criteria

Must be an adult, meaning you are 18 years or older.
Must be receiving your first kidney transplant from a living donor who is not a perfect match in terms of HLA. HLA stands for human leukocyte antigen, which is a protein on cells that helps the immune system recognize which cells belong in your body.
The transplant must be AB0 compatible, meaning your blood type is compatible with the donor's blood type.
Your PRA must be 75% or less. PRA stands for panel reactive antibody, which is a test that shows how likely your body is to reject a transplanted organ. You should not have any specific antibodies against the donor's HLA.
You must agree to participate in the study by signing a document called the Informed Consent, which explains the study in detail.
If you are a woman who can become pregnant, you must use very reliable birth control methods during the study and for 6 weeks after finishing treatment with a medication called Mycophenolate Mofetil (MMF). This includes women who have started menstruating and have not had surgery to prevent pregnancy or are not in menopause. Menopause is when you have not had a period for 12 months in a row. You must also have a negative pregnancy test within 72 hours before starting the study.
If you are a sexually active man, even if you have had a vasectomy, you must use barrier methods of birth control while taking MMF and for 90 days after. Your partner should also use reliable birth control during this time to prevent pregnancy.
You must agree not to donate blood while taking MMF and for 6 weeks after stopping the medication. Men must also agree not to donate sperm during treatment and for 90 days after finishing treatment.

Who cannot join the trial?

4 criteria

Patients who have not received a kidney transplant cannot participate. A kidney transplant is a surgery to place a healthy kidney from a donor into someone whose kidneys no longer work properly.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may have additional risks or need special protection.
Patients who do not meet the specific medical conditions required for the study cannot participate. The study is focused on individuals with certain health conditions.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Bellvitge University Hospital
Verified
L'hospitalet De Llobregat, Spain
Fundacio Puigvert
Verified
Barcelona, Spain
Hospital Clinic De Barcelona
Verified
Barcelona, Spain

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Investigated drugs

Immunosuppressive Therapy is used to prevent the body from rejecting a transplanted kidney. In this study, the therapy is adjusted based on specific biomarkers to better match the patient's individual immunological risk. This personalized approach aims to improve the success of the kidney transplant by reducing the chances of rejection and maintaining kidney function.

What is already known about the treatment

Immunosuppressive Therapy – This medication is administered orally or intravenously, depending on the specific drug used within the therapy. It is currently being studied in clinical trials to optimize treatment for kidney transplant patients. The main therapeutic indication is to prevent organ rejection in patients who have received a kidney transplant from a living donor. The mechanism of action involves modulating the immune system to reduce the activity of immune cells that might attack the transplanted organ. It is classified pharmacologically as an immunosuppressant.

Investigated diseases

Kidney Transplant – A kidney transplant is a surgical procedure where a healthy kidney from a donor is placed into a person whose kidneys no longer function properly. This procedure is often necessary for individuals with end-stage kidney disease. After the transplant, the recipient's body may recognize the new kidney as foreign, leading to an immune response. This can result in acute rejection, where the body's immune system attacks the transplanted kidney. Over time, chronic rejection can occur, gradually damaging the kidney. To prevent rejection, patients typically require lifelong immunosuppressive medication to help the body accept the new organ.