A Study of TCD601 in de Novo Renal Transplant Recipients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Renal Transplantation

Intervention / Treatment
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* Biological: TCD601
* Biological: belatacept
* Drug: ATG
* Drug: TAC
* Drug: MPA
* Drug: Corticosteroids


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TCD601 (siplizumab)<br>TCD601 administered in combination with belatacept, mycophenolic Acid (MPA), and corticosteroids | Biological: TCD601<br>* Investigational Product<br>* Other names: siplizumab;Biological: belatacept<br>* Study Product<br>Drug: MPA<br>* Immunosuppression Therapy<br>* Other names: mycophenolic acid;Drug: Corticosteroids<br>* Immunosuppression Therapy<br>|
| Active Comparator: ATG<br>Antithymocyte globulin (ATG), tacrolimus (TAC), mycophenolic acid (MPA), and corticosteroids | Drug: ATG<br>* Comparator<br>* Other names: antithymocyte globulin;Drug: TAC<br>* Comparator<br>* Other names: tacrolimus;Drug: MPA<br>* Immunosuppression Therapy<br>* Other names: mycophenolic acid;Drug: Corticosteroids<br>* Immunosuppression Therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse events (AEs) and serious adverse events (SAEs) in Arm 1 compared to Arm 2 | The number of adverse events and serious adverse events | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function in Arm 1 compared to Arm 2 | renal function using estimated glomerular filtration rate (eGFR) | 12 months |