A 12-Month, Randomized, Controlled, Open-Label, Dose Escalation Study Evaluating Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of an Anti-CD2 Monoclonal Antibody, TCD601 (Siplizumab) Compared to Anti-thymocyte Globulin (rATG), as Induction Therapy in de Novo Renal Transplant Recipients
Overview
- Phase
- Phase 2
- Intervention
- TCD601
- Conditions
- Kidney Transplantation
- Sponsor
- ITB-Med LLC
- Enrollment
- 33
- Locations
- 7
- Primary Endpoint
- Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0.
- Status
- Terminated
- Last Updated
- last month
Overview
Brief Summary
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients.
Investigators
Eligibility 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 unrelated, or non-HLA identical living related donor.
- •Recipients of a kidney with a cold ischemia time (CIT) less than 30 hours.
Exclusion Criteria
- •Multiple-organ transplant recipients
- •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
- •Subjects at high immunological risk for rejection
Arms & Interventions
Arm 1
TCD601 0.2 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Intervention: TCD601
Arm 1
TCD601 0.2 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Intervention: Tacrolimus (TAC)
Arm 1
TCD601 0.2 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Intervention: Corticosteroids (CS)
Arm 1
TCD601 0.2 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Intervention: Mycophenolate Mofetil (MMF)
Arm 2
TCD601 0.6 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Intervention: TCD601
Arm 2
TCD601 0.6 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Intervention: Tacrolimus (TAC)
Arm 2
TCD601 0.6 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Intervention: Corticosteroids (CS)
Arm 2
TCD601 0.6 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Intervention: Mycophenolate Mofetil (MMF)
Arm 3
TCD601 1.7 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Intervention: TCD601
Arm 3
TCD601 1.7 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Intervention: Tacrolimus (TAC)
Arm 3
TCD601 1.7 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Intervention: Corticosteroids (CS)
Arm 3
TCD601 1.7 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Intervention: Mycophenolate Mofetil (MMF)
Arm 4
TCD601 5.0 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Intervention: TCD601
Arm 4
TCD601 5.0 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Intervention: Tacrolimus (TAC)
Arm 5
ATG 1.5 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Intervention: ATG
Arm 4
TCD601 5.0 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Intervention: Corticosteroids (CS)
Arm 4
TCD601 5.0 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Intervention: Mycophenolate Mofetil (MMF)
Arm 5
ATG 1.5 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Intervention: Tacrolimus (TAC)
Arm 5
ATG 1.5 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Intervention: Corticosteroids (CS)
Arm 5
ATG 1.5 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
Intervention: Mycophenolate Mofetil (MMF)
Outcomes
Primary Outcomes
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0.
Time Frame: 12 months
Measure Peak TCD601 Plasma Concentration (Cmax) Over Time.
Time Frame: 12 months
The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration.
Measure the Area Under the TCD601 Plasma Concentration Versus Time Curve (AUC).
Time Frame: 12 months
The AUC from time zero to the last measurable concentration sampling time.
Secondary Outcomes
- The Incidence of Allograft Rejection at 12 Months Post-Transplant(12 months)
- To Assess Renal Function Over Time(12 months)