Study on Switching from Tacrolimus or Ciclosporin to Belatacept for Adolescents with Kidney Transplants

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What is this study about?

This clinical trial is focused on studying treatments for adolescents who have received a kidney transplant, also known as a renal allograft. The study involves two different types of medications used to prevent the body from rejecting the transplanted kidney. One group of participants will continue using a type of medication called calcineurin inhibitors, which includes drugs like tacrolimus and ciclosporin. The other group will switch to a medication called belatacept, which is given through an infusion into a vein. Belatacept is also known by its code name LEA29Y or BMS224818.

The purpose of the study is to evaluate the benefits and risks of switching from calcineurin inhibitors to belatacept in these young patients. The study will observe how well the kidney transplant continues to function and how well the patients adhere to their medication schedules. Participants will be randomly assigned to either continue their current medication or switch to belatacept. The study will last for 24 months, during which time the health of the kidney transplant and the overall well-being of the participants will be monitored.

This study is important for understanding whether switching to belatacept can provide better outcomes for adolescent kidney transplant recipients compared to continuing with calcineurin inhibitors. The findings could help improve treatment strategies and long-term health for young people who have undergone kidney transplants.

1 joining the study

Upon joining the study, participants are randomly assigned to one of two groups. One group will continue their current medication, while the other group will switch to a new medication regimen.

2 medication regimen

Participants continuing their current treatment will keep taking tacrolimus or ciclosporin orally. The exact dosage and frequency will be based on the participant’s current prescription.

Participants switching to the new regimen will receive belatacept through an intravenous infusion. The healthcare team will provide specific instructions on the dosage and frequency.

3 regular check-ups

Participants will attend regular check-ups to monitor their health and the function of their kidney transplant. These check-ups will include blood tests and other assessments as needed.

4 monitoring and feedback

Throughout the study, participants will be asked to provide feedback on their health and any side effects experienced. This information is crucial for evaluating the safety and effectiveness of the treatment.

5 end of study

The study will conclude 24 months after the participant’s randomization. At this point, the final assessments will be conducted to evaluate the outcomes of the treatment.

Who Can Join the Study?

  • Must be a male or female between the ages of 12 and less than 18 years old.
  • Must have documented EBV seropositivity before the transplant and randomization.
    (This means you have been tested and found to have antibodies against the Epstein-Barr Virus, which shows past infection.)
  • Must be receiving a stable medication regimen that includes a CNI (calcineurin inhibitor) and mycophenolate, with or without corticosteroids, for more than 1 month before randomization.
    (This means your current medication plan has not changed recently and includes specific drugs to help prevent organ rejection.)
  • Must have stable kidney function for 12 weeks before screening, as assessed by the study doctor and based on specific criteria for eGFR and proteinuria.
    (This means your kidney function has been consistent and meets certain medical standards.)

Who Cannot Join the Study?

  • Patients who have not had a kidney transplant at least 6 months ago cannot participate.
  • Patients who are not adolescents (typically ages 10-19) cannot participate.
  • Patients who are not currently taking a medication called CNI (Calcineurin Inhibitor) cannot participate. This is a type of drug that helps prevent the body from rejecting a transplanted organ.
  • Patients who are unable to switch to a medication called belatacept cannot participate. Belatacept is a drug used to help prevent organ rejection after a kidney transplant.
  • Patients who are not willing to follow the study procedures and requirements cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Hopital Necker Enfants Malades Paris France

Other Sites

Site Name City Country Status
Robert Debre University Hospital Paris France
IRCCS Istituto Giannina Gaslini Genoa Italy
Virgen del Rocío University Hospital Sevilla Spain
Centre Hospitalier Universitaire De Nantes Nantes France
Hospices Civils De Lyon Lyon France
Universitair Ziekenhuis Gent Gent Belgium
Pellegrin Hospital Bordeaux France
Aprulwxzm Utp Amsterdam The Netherlands
Ufhrurqgcm Htoihzmq Cbhuqsv Cologne Germany
Aabzolylzc Pyhgxzwj Hcnjrbgs Dk Mvqmzcgwz Marseille France
Ajjnssn Opiklpenict Urgfwajyeepxq Cmkxahbcxmlf Dmwhe Skpugs E Dscao Sytxqnn Dt Twgmve Turin Italy
Umsijodhfg Mbusifv Ckalwz Hlujfvfmfzdgpzeaa Hamburg Germany
Umnjentzybnvyesnrvtom Eewnf Amj Essen Germany
Fzdkpgfeq Pgib Lc Ivetpyixdejav Bysckusde Djk Hsbdjxrv Uibgiwgxbqcuo Lw Pti Madrid Spain
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
26.02.2021
France France
Recruiting
26.02.2021
Germany Germany
Recruiting
26.02.2021
Italy Italy
Recruiting
26.02.2021
Spain Spain
Not recruiting
26.02.2021
The Netherlands The Netherlands
Recruiting
26.02.2021

Trial locations

Belatacept is a medication used to help prevent the body from rejecting a transplanted kidney. It works by weakening the immune system so that it does not attack the new kidney. In this trial, belatacept is being tested to see if it can be a better option for young people who have had a kidney transplant, compared to other medications they might be taking.

Calcineurin Inhibitors are a group of medications that are commonly used to prevent organ rejection in people who have received a transplant. They work by suppressing the immune system to stop it from attacking the transplanted organ. In this study, the effects of continuing with calcineurin inhibitors are being compared to switching to belatacept to see which is more effective for young kidney transplant recipients.

Investigated diseases:

Adolescent Renal Allografts – Adolescent renal allografts refer to kidney transplants received by individuals in their teenage years. After transplantation, the body may recognize the new kidney as foreign, potentially leading to immune responses. Over time, the transplanted kidney may experience changes in function, which can be monitored through measures like estimated glomerular filtration rate (eGFR). The progression of the condition involves maintaining the health and function of the transplanted kidney while managing the body’s immune response. The focus is on ensuring the kidney continues to function properly and supports the body’s needs. Regular monitoring and adjustments in care are essential to support the long-term health of the transplant.

Trial ID:
2022-501677-39-00
Protocol code:
IM103402
NCT ID:
NCT04877288
Trial Phase:
Therapeutic confirmatory (Phase III)

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