90 Participants Needed

TCD601 + Belatacept for Kidney Transplant

(ASCEND Trial)

Recruiting at 27 trial locations
BJ
Overseen ByBritain Javens, MS
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: ITB-Med LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human 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

NH

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

You understand what the study involves and can give written permission before any study tests are done.
You received a kidney transplant from a deceased or living donor who is a good match for you.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TCD601 in combination with belatacept, MPA, and corticosteroids or standard of care immunosuppression therapy

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

  • ATG
  • Belatacept
  • Corticosteroids
  • MPA
  • TAC
  • TCD601
Trial Overview The trial is testing TCD601 in combination with Belatacept against standard immunosuppression treatments in patients receiving their first kidney transplant, aiming to see if it's safe and works well.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: TCD601 (siplizumab)Experimental Treatment4 Interventions
TCD601 administered in combination with belatacept, mycophenolic Acid (MPA), and corticosteroids
Group II: ATGActive Control4 Interventions
Antithymocyte globulin (ATG), tacrolimus (TAC), mycophenolic acid (MPA), and corticosteroids

ATG is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Thymoglobulin for:
  • 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
🇪🇺
Approved in European Union as Thymoglobulin for:
  • 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
🇨🇦
Approved in Canada as Thymoglobulin for:
  • 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

Trials
12
Recruited
390+

Findings from Research

In a case study of an HIV-positive kidney transplant recipient, early conversion to belatacept improved renal function without causing HIV disease progression or opportunistic infections.
The case suggests that belatacept can be a safe and effective option for enhancing kidney function while minimizing drug interactions, even after the use of anti-thymocyte globulin (ATG).
Belatacept conversion in an HIV-positive kidney transplant recipient following anti-thymocyte globulin induction.Kuten, SA., Patel, SJ., Baru, A., et al.[2018]
In a proof-of-concept study involving 12 kidney transplant recipients, a regimen combining belatacept, mycophenolic acid, steroids, and rabbit anti-thymocyte globulin significantly reduced acute rejection rates, with only 2 out of 12 patients experiencing rejection.
The study demonstrated that this treatment approach was safe, as no patients developed serious complications like post-transplant lymphoproliferative disorder, and all patients maintained their grafts without any deaths during the follow-up period.
Belatacept-based, ATG-Fresenius-induction regimen for kidney transplant recipients: a proof-of-concept study.Cicora, F., Mos, F., Petroni, J., et al.[2015]
In a study of pediatric kidney transplant recipients, Thymoglobulin induction therapy resulted in a significantly lower incidence of acute rejection (33%) compared to ATGAM (50%), indicating its efficacy in preventing rejection.
However, Thymoglobulin was associated with a higher rate of Epstein-Barr virus (EBV) infection (8% vs. 3% for ATGAM), suggesting the need for careful monitoring of EBV in patients receiving this treatment.
Thymoglobulin versus ATGAM induction therapy in pediatric kidney transplant recipients: a single-center report.Khositseth, S., Matas, A., Cook, ME., et al.[2019]

References

Belatacept conversion in an HIV-positive kidney transplant recipient following anti-thymocyte globulin induction. [2018]
Belatacept-based, ATG-Fresenius-induction regimen for kidney transplant recipients: a proof-of-concept study. [2015]
Thymoglobulin versus ATGAM induction therapy in pediatric kidney transplant recipients: a single-center report. [2019]
Immunotherapy for De Novo renal transplantation: what's in the pipeline? [2018]
Analysis of Immune Cell Repopulation After Anti-thymocyte Globulin Administration for Steroid-Resistant T-cell-mediated Rejection. [2020]
Immunosuppression with belatacept-based, corticosteroid-avoiding regimens in de novo kidney transplant recipients. [2023]
Efficacy and safety of thymoglobulin induction as an alternative approach for steroid-free maintenance immunosuppression in pediatric renal transplantation. [2022]
Belatacept: from rational design to clinical application. [2017]
Thymoglobulin for induction or rejection therapy in pancreas allograft recipients: a single centre experience. [2019]
Belatacept for the prophylaxis of organ rejection in kidney transplant patients: an evidence-based review of its place in therapy. [2020]
Alemtuzumab induction and belatacept maintenance in marginal pathology renal allografts. [2020]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security