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Study on the Safety of TX200-TR101 for Preventing Kidney Transplant Rejection in Patients Receiving a Living Donor Transplant

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What is this study about?

This clinical trial is focused on studying a treatment for people who have received a kidney transplant from a living donor. The main concern in such cases is preventing the body from rejecting the new kidney, a condition known as renal transplant rejection. The treatment being tested is called TX200-TR101, which is a type of cell therapy. This therapy involves using a special kind of cell called a Chimeric Antigen Receptor T Regulatory Cell, which is designed to help the body accept the new kidney.

The purpose of the study is to evaluate the safety and tolerability of TX200-TR101 in patients who have received a kidney transplant. Participants in the study will receive a single dose of this treatment through an infusion, which means it will be delivered directly into the bloodstream. The study will monitor participants for any side effects or reactions to the treatment over a period of time, starting from the day of the infusion and continuing for several weeks.

Throughout the study, researchers will keep track of any health changes in the participants, including any signs of the body rejecting the kidney or other health issues. The study aims to gather information on how well the treatment works in helping the body accept the new kidney and whether it is safe for use in patients. This information will help determine if TX200-TR101 could be a beneficial treatment option for kidney transplant recipients in the future.

1 joining the study

Upon joining the study, the participant will have already provided written informed consent, confirming understanding and agreement to participate in the trial.

Eligibility criteria include being between 18 and 70 years old, having end-stage renal disease, and awaiting a kidney transplant from a living donor.

2 preparation for infusion

Before the infusion of TX200-TR101, a solution for infusion administered intravenously, the participant will undergo necessary pre-infusion assessments to ensure safety and readiness for the procedure.

3 infusion of TX200-TR101

The participant will receive a single dose of TX200-TR101 through an intravenous infusion. This is a specialized cell therapy designed to help prevent kidney transplant rejection.

4 post-infusion monitoring

For 28 days following the infusion, the participant will be closely monitored to evaluate the short-term safety and tolerability of the treatment.

Monitoring will include checking for any adverse effects and ensuring the participant’s well-being.

5 long-term follow-up

The participant will continue to be monitored up to Week 84 to assess the incidence of transplant rejection and any other health changes.

Regular assessments will include checking for infections, monitoring kidney function, and evaluating the effectiveness of the treatment.

Who Can Join the Study?

  • Willing and able to provide written informed consent, which means agreeing to participate in the study after understanding all the details and risks involved.
  • Must be between 18 and 70 years old.
  • Have a diagnosis of ESRD, which stands for End-Stage Renal Disease, and currently waiting for a new kidney from a live donor.
  • Will receive only one organ, specifically a kidney.
  • Have a normal or not seriously abnormal ECG, which is a test that checks the heart’s electrical activity, as determined by the study doctor.
  • Women who can have children must have a negative pregnancy test at the start of the study and before the kidney transplant.
  • Must be able and willing to use a very effective method of birth control from the time of agreeing to participate in the study until the last study visit, for both men and women who can have children.

Who Cannot Join the Study?

  • Patients who are not within the specified age range for the study.
  • Patients who are not eligible based on gender requirements.
  • Patients who are considered part of a vulnerable population, which means they might be at higher risk of harm or exploitation.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Universiteit Leiden Leiden The Netherlands
Uzbgmprldgbh Mezkris Cpmysbt Gbhilvivj Groningen The Netherlands
Ecpxjfd Uilxsxoelpno Mkritxl Cgieuwv Rqtcyhhht (sosejqi Mlw Rotterdam The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
17.03.2021
The Netherlands The Netherlands
Not recruiting
17.03.2021

Trial locations

Investigated drugs:

TX200-TR101 is a type of cell therapy used in this clinical trial. It involves using a patient’s own cells, which are modified to help regulate the immune system. This therapy is specifically designed for patients who have received a kidney transplant from a living donor. The goal of TX200-TR101 is to improve the body’s acceptance of the new kidney by reducing the immune response that can lead to rejection. This trial aims to assess how safe and tolerable this therapy is for patients shortly after they receive it.

Renal Transplant Rejection – This condition occurs when the immune system of a person who has received a kidney transplant attacks the new kidney, mistaking it for a foreign object. The rejection can be acute, happening shortly after the transplant, or chronic, developing over a longer period. Symptoms may include decreased kidney function, pain or tenderness over the kidney, and changes in urine output. The immune response can lead to inflammation and damage to the transplanted kidney tissue. Over time, this can affect the kidney’s ability to function properly. Monitoring and managing the immune response is crucial to maintaining the health of the transplanted kidney.

Trial ID:
2024-512579-11-00
Protocol code:
TX200-KT02
NCT ID:
NCT04817774
Trial Phase:
Phase I and Phase II (Integrated) – First administration to humans

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