Brief Summary
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.
Brief Title
A Study of TCD601 in de Novo Renal Transplant Recipients
Detailed Description
The purpose of this study is to evaluate the safety and efficacy of TCD601 (siplizumab), an anti-CD2 monoclonal antibody, in combination with a CNI-free regimen of belatacept, MPA, and corticosteroids compared to a standard of care CNI-based regimen of tacrolimus, ATG, MPA and corticosteroids in de novo renal transplant patients.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Renal Transplantation
Eligibility Criteria
Key Inclusion Criteria:
* Able to understand the study requirements and provide written informed consent before and study assessment is performed
* Male or female patients ≥ 18 to 70 years of age
* Recipients of a de novo renal allograft from a heart-beating deceased, living ABO compatable, non-HLA identical living related donor
Key Exclusion Criteria:
* Subjects who have received a kidney allograft previously
* Recipient of a kidney from an HLA identical living related donor
* Recipient of a kidney from a donor after cardiac death
* Able to understand the study requirements and provide written informed consent before and study assessment is performed
* Male or female patients ≥ 18 to 70 years of age
* Recipients of a de novo renal allograft from a heart-beating deceased, living ABO compatable, non-HLA identical living related donor
Key Exclusion Criteria:
* Subjects who have received a kidney allograft previously
* Recipient of a kidney from an HLA identical living related donor
* Recipient of a kidney from a donor after cardiac death
Inclusion Criteria
Inclusion Criteria:
* Able to understand the study requirements and provide written informed consent before and study assessment is performed
* Male or female patients ≥ 18 to 70 years of age
* Recipients of a de novo renal allograft from a heart-beating deceased, living ABO compatable, non-HLA identical living related donor
* Able to understand the study requirements and provide written informed consent before and study assessment is performed
* Male or female patients ≥ 18 to 70 years of age
* Recipients of a de novo renal allograft from a heart-beating deceased, living ABO compatable, non-HLA identical living related donor
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
70 Years
Minimum Age
18 Years
NCT Id
NCT05669001
Org Class
Industry
Org Full Name
ITB-Med LLC
Org Study Id
TCD601B203
Overall Status
Active, not recruiting
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A 12-Month, Randomized, Open-Label, Phase IIA Study Evaluating the Safety and Efficacy of Siplizumab in Combination With Belatacept and MPA Compared to Standard of Care Immunosuppression in de Novo Renal Transplant Recipients (ASCEND)
Primary Outcomes
Outcome Description
The number of adverse events and serious adverse events
Outcome Measure
The incidence of adverse events (AEs) and serious adverse events (SAEs) in Arm 1 compared to Arm 2
Outcome Time Frame
12 months
Secondary Outcomes
Outcome Description
renal function using estimated glomerular filtration rate (eGFR)
Outcome Time Frame
12 months
Outcome Measure
Renal function in Arm 1 compared to Arm 2
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
70
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Enver Akalin
Investigator Email
eakalin@montefiore.org
Investigator Phone
718-920-4815