Study on Replacing CNIs with Belatacept for Kidney Transplant Patients with Early Graft Dysfunction 3 to 12 Months Post-Transplant

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What is this study about?

This clinical trial is focused on patients who have undergone a kidney transplant and are experiencing early issues with their new kidney, known as early graft dysfunction. The study is investigating the use of a medication called Belatacept, which is marketed under the name NULOJIX. This medication is given as a solution through an intravenous infusion, which means it is administered directly into the bloodstream through a vein. The purpose of the study is to see if Belatacept can temporarily replace other medications called CNIs (calcineurin inhibitors) in these patients, starting from 3 to 12 months after their transplant.

Participants in the study will receive Belatacept for a period of 9 months. During this time, their kidney function will be closely monitored to ensure that the medication is working effectively and that there are no significant side effects. After the 9-month period, the study will assess whether it is feasible to reintroduce CNIs while maintaining good kidney function and tolerance to the treatment. The study will also track any episodes of infection, changes in kidney function, and overall quality of life during the 15-month follow-up period.

The trial aims to gather information on how well patients tolerate the switch from CNIs to Belatacept and back again, and whether this approach can help improve outcomes for kidney transplant patients with early graft dysfunction. By monitoring various health indicators and quality of life, the study hopes to provide valuable insights into the management of kidney transplant patients.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. Written informed consent is required to participate.

Eligibility criteria include being over 18 years of age, having a kidney transplant from a compatible donor, and meeting specific health conditions.

2 initial assessment

An initial assessment will be conducted to ensure the patient meets all criteria, including a kidney biopsy at 10 weeks post-transplant to confirm no rejection or other complications.

A negative pregnancy test is required for patients of childbearing age, along with agreement to use effective contraception during the study.

3 treatment phase

The treatment phase involves replacing current medications with belatacept, administered as an intravenous infusion. This phase lasts for 9 months, starting 3 to 12 months after the transplant.

The medication used is NULOJIX 250 mg powder for concentrate for solution for infusion.

4 monitoring and follow-up

Regular monitoring of kidney function will occur at months 0, 3, 6, and 9. This includes checking for any rejection events or infections.

Quality of life will be assessed every 3 months using a standard scale, and any changes in health will be documented.

5 reintroduction of previous medication

After the 9-month treatment phase, previous medications may be reintroduced. The feasibility of this step will be evaluated based on kidney function and tolerance.

Kidney function is considered preserved if it does not decrease by more than 25% after stopping belatacept.

6 final assessment

A final assessment will be conducted 6 months after reintroducing previous medications to ensure kidney function is stable and there are no complications.

The study will also analyze the immune response and other health indicators before and after stopping belatacept.

Who Can Join the Study?

Must be an adult over 18 years of age.
Must have no difficulty understanding and communicating with the study team.
Must be affiliated with the French social security system or be a beneficiary of it.
Must have received a kidney transplant from a deceased or living donor with compatible blood types.
Must have no contraindication (no medical reason to avoid) to a kidney biopsy 10 weeks after the transplant.
Must be on a maintenance treatment with specific medications (CNI/MPA with or without prednisone).
Must have reduced kidney function as estimated by a specific test (CKD-EPI creatinine clearance less than 30 ml/min/1.73m²).
Must be willing to give written informed consent after receiving information about the study.
Results of the kidney biopsy 10 weeks after the transplant must show no rejection, no BK virus nephropathy, no recurrence of the initial disease, no thrombotic microangiopathy, and no cortical necrosis.
Must be positive for EBV (Epstein-Barr Virus) antibodies, indicating past infection.
For patients of childbearing age, must have a negative pregnancy test and agree to use effective contraception throughout the study.

Who Cannot Join the Study?

Patients who have had a kidney transplant cannot participate.
Patients with early graft dysfunction are not eligible. This means the transplanted kidney is not working well soon after the surgery.
Patients who are not within the specified age range cannot participate. The study is for certain age groups only.
Both male and female patients are considered, but specific criteria may apply.
Patients who are part of a vulnerable population are not eligible. This refers to groups who may need special protection or care.

Where you can join this trial?

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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	Not recruiting	01.06.2022

Trial locations

Investigated drugs:

Belatacept

Belatacept is a medication used in this clinical trial to help kidney transplant patients. It works by suppressing the immune system to prevent it from attacking the new kidney. This is important because the body naturally tries to reject a transplanted organ. In this study, belatacept is being tested as a temporary replacement for other immune-suppressing drugs called CNIs, which are usually given to patients after a transplant. The goal is to see if belatacept can be a safe and effective alternative for patients who are experiencing early problems with their new kidney.

Kidney Transplant – A kidney transplant is a surgical procedure in which a healthy kidney from a donor is placed into a person whose kidneys are no longer functioning properly. The transplanted kidney takes over the work of filtering blood and producing urine, which the recipient’s own kidneys can no longer do. After the transplant, the body may initially recognize the new kidney as foreign, leading to a risk of rejection. Over time, the immune system may attack the transplanted kidney, causing damage and potentially leading to graft dysfunction. The progression of kidney function is monitored through various tests, including creatinine clearance, to ensure the transplanted kidney is working effectively. Regular follow-up is necessary to manage any complications and to maintain the health of the transplanted kidney.

Trial ID:

2022-500299-71-00

Protocol code:

RC21_0587

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Replacing CNIs with Belatacept for Kidney Transplant Patients with Early Graft Dysfunction 3 to 12 Months Post-Transplant

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