A Study of TCD601 in de Novo Renal Transplant Recipients

Purpose

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.

Condition

  • Renal Transplantation

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
TCD601 (siplizumab) 		TCD601 administered in combination with belatacept, mycophenolic Acid (MPA), and corticosteroids
  • Biological: TCD601
    Investigational Product
    Other names:
    • siplizumab
  • Biological: belatacept
    Study Product
  • Drug: MPA
    Immunosuppression Therapy
    Other names:
    • mycophenolic acid
  • Drug: Corticosteroids
    Immunosuppression Therapy
Active Comparator
ATG 		Antithymocyte globulin (ATG), tacrolimus (TAC), mycophenolic acid (MPA), and corticosteroids
  • Drug: ATG
    Comparator
    Other names:
    • antithymocyte globulin
  • Drug: TAC
    Comparator
    Other names:
    • tacrolimus
  • Drug: MPA
    Immunosuppression Therapy
    Other names:
    • mycophenolic acid
  • Drug: Corticosteroids
    Immunosuppression Therapy

Recruiting Locations

UT Health San Antonio
San Antonio, Texas 78229
Contact:
Study Coordinator

More Details

Status
Recruiting
Sponsor
ITB-Med LLC

Study Contact

Britain Javens, MS
(212) 969-7823
britain.javens@itb-med.com

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.