Study on Reducing or Stopping Immunosuppression with Tacrolimus and Ciclosporin in Patients with Late Kidney Transplant Failure

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What is this study about?

This clinical trial is focused on patients who have experienced a late failure of a kidney transplant, known as renal graft failure. The study is investigating the effects of continuing or stopping the use of medications that suppress the immune system, called immunosuppressants, to prevent the body from developing a reaction against the kidney transplant. The medications being studied include tacrolimus and cyclosporin, which are commonly used to help prevent the body from rejecting a transplanted organ. The purpose of the study is to compare the level of immune response, specifically the development of human leukocyte antigen (HLA) sensitization, in patients who either continue or stop taking these medications after six months.

Participants in the study will be randomly assigned to one of two groups. One group will continue taking their immunosuppressant medication, while the other group will stop taking it after six months. The study will last for 24 months, during which time the participants’ immune response will be monitored to see if there is a difference in the level of HLA sensitization between the two groups. This will help determine if it is safe to stop taking immunosuppressants after a certain period without increasing the risk of the body developing a reaction against the kidney transplant.

The study aims to provide valuable information on the management of immunosuppressant therapy in patients with late renal graft failure. By understanding the effects of continuing versus stopping these medications, the study hopes to improve the long-term outcomes for patients who have undergone kidney transplantation. Participants will be closely monitored throughout the study to ensure their safety and to gather data on the effectiveness of the treatment strategies being tested.

1 joining the study

Upon joining the study, the patient will be randomly assigned to one of two groups. This assignment will determine whether the patient continues or stops taking immunosuppressive medication after six months.

2 initial treatment phase

During the first six months, the patient will continue taking immunosuppressive medications. These medications include tacrolimus and ciclosporin, which are taken orally in the form of capsules or tablets.

The specific medication and dosage will be determined by the study protocol and the patient’s medical condition.

3 randomization at six months

At the six-month mark, the patient will be evaluated to determine the next steps in their treatment plan.

Depending on the group assignment, the patient will either continue with the immunosuppressive treatment or stop taking the medication.

4 continued treatment or cessation

If assigned to continue treatment, the patient will maintain the prescribed immunosuppressive regimen for the remainder of the study period.

If assigned to stop treatment, the patient will cease taking the immunosuppressive medications and will be monitored for any changes in health status.

5 monitoring and follow-up

Throughout the 24-month study period, the patient will undergo regular health assessments to monitor the degree of HLA sensitization and overall health.

These assessments will help determine the effectiveness and safety of continuing versus stopping immunosuppressive treatment.

6 study conclusion

At the end of the 24-month study period, the patient will have a final evaluation to assess the outcomes of their treatment plan.

The results will contribute to understanding the impact of continued versus stopped immunosuppression in patients with late renal graft failure.

Who Can Join the Study?

The patient must be able to understand and provide written consent to participate in the study.
The patient must be older than 18 years.
The patient must have had at least one previous kidney transplant.
The patient must have a failed kidney transplant that lasted at least 3 months.
The patient must be on dialysis, which is a treatment that helps clean the blood when the kidneys are not working well. This can be either hemodialysis (using a machine to filter the blood) or peritoneal dialysis (using the lining of the abdomen to filter the blood). The patient can be on dialysis for a maximum of 6 months at the time of joining the study.
The patient must have been taking a continuous treatment with immunosuppressive drugs (medications that lower the body’s immune response) such as calcineurin inhibitors (like tacrolimus or cyclosporine) and steroids since starting dialysis again.
The patient must already be on the waiting list or be a candidate to be relisted for a kidney transplant from a deceased donor, as determined by their doctor.
The patient must be taking the immunosuppressants tacrolimus or cyclosporine.
The patient’s cPRA (calculated Panel Reactive Antibody, a measure of how sensitized the immune system is to potential donor organs) must be 90% or less at the time of joining the study.

Who Cannot Join the Study?

Patients who have not experienced a renal transplantation. This means patients who have not received a kidney from a donor.
Patients who have not experienced late renal graft failure. This refers to the kidney transplant not working properly after more than 3 months.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means groups that might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain

Other Sites

Site Name	City	Country
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Hospital Del Mar	Barcelona	Spain
Fundacio Puigvert	Barcelona	Spain
Hbmribow Uzrxetbvntjhg Hdtorncu Tvulu y Ptlhah Infyrzfq Cjchmv dcekicwggqncktnii (hgjo	Badalona	Spain
Hzuwdcrv Vgvk dhfppssr	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	02.11.2023

Trial locations

Investigated drugs:

Immunosuppressants are medications used to lower the body’s immune response. In this clinical trial, they are being used to prevent the immune system from attacking a transplanted kidney. The study is comparing the effects of continuing these medications versus stopping them after six months in patients who have experienced late kidney transplant failure. The goal is to see if continuing or stopping the medication affects the development of antibodies against the transplanted organ.

Investigated diseases:

Renal transplant

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 are unable to filter waste and excess fluids from the blood, leading to a buildup of harmful substances in the body. Over time, the transplanted kidney takes over the function of filtering blood, which helps in maintaining a balance of fluids and electrolytes. The progression of this condition involves the body’s immune system potentially recognizing the new kidney as foreign, which can lead to rejection. To prevent this, patients often require immunosuppressive medications to reduce the risk of rejection. The success of the transplant can be influenced by various factors, including the degree of HLA sensitization and the management of immunosuppressive therapy.

Trial ID:

2023-506879-98-00

Protocol code:

PREVSENSI

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Reducing or Stopping Immunosuppression with Tacrolimus and Ciclosporin in Patients with Late Kidney Transplant Failure

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?