TCD601 + Belatacept for Kidney Transplant
(ASCEND Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug TCD601 + Belatacept for kidney transplant?
Belatacept has been shown to improve kidney function in transplant recipients and avoid significant drug interactions, even after anti-thymocyte globulin (ATG) induction. Additionally, a study found that a belatacept-based regimen, including ATG, mycophenolic acid, and steroids, provided effective immunosuppression with reduced rejection rates, making it a promising approach for kidney transplant patients.12345
Is the combination of TCD601 and Belatacept safe for kidney transplant patients?
The combination of TCD601 (also known as Thymoglobulin) and Belatacept has been studied in kidney transplant patients, showing comparable safety to other regimens. While there are concerns about higher rejection rates and infections, no patients developed serious conditions like post-transplant lymphoproliferative disorder (PTLD) or lost their grafts in the studies reviewed.26789
What makes the drug TCD601 + Belatacept unique for kidney transplant patients?
The drug TCD601 + Belatacept is unique because it aims to improve kidney transplant outcomes by avoiding the use of calcineurin inhibitors (CNIs) and corticosteroids, which can have harmful side effects. This combination may offer better kidney function and fewer drug interactions compared to traditional treatments.1261011
What is the purpose of this trial?
The purpose of this study is to evaluate the safety and efficacy of TCD601 in combination with Belatacept when compared to standard of care immunosuppression therapy in de novo renal transplant patients.
Research Team
Nick Hryciw, BS, MA
Principal Investigator
ITB-Med LLC
Eligibility Criteria
This trial is for adults aged 18 to 70 who are getting a new kidney from either a living donor or deceased with a matching blood type but not necessarily an exact tissue match. They must understand the study and agree to participate.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive TCD601 in combination with belatacept, MPA, and corticosteroids or standard of care immunosuppression therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- ATG
- Belatacept
- Corticosteroids
- MPA
- TAC
- TCD601
ATG is already approved in United States, European Union, Canada for the following indications:
- Prevention and treatment of acute rejection in patients undergoing kidney transplantation
- Treatment of aplastic anemia in patients who are not candidates for bone marrow transplantation
- Prevention and treatment of acute rejection in patients undergoing kidney transplantation
- Treatment of aplastic anemia in patients who are not candidates for bone marrow transplantation
- Prevention and treatment of acute rejection in patients undergoing kidney transplantation
- Treatment of aplastic anemia in patients who are not candidates for bone marrow transplantation
Find a Clinic Near You
Who Is Running the Clinical Trial?
ITB-Med LLC
Lead Sponsor