A Dose Escalation Study in de Novo Renal Transplantation
Phase 2
Completed
- Conditions
- Kidney Transplantation
- Interventions
- Drug: Corticosteroids (CS)
- Registration Number
- NCT04311632
- Lead Sponsor
- ITB-Med LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
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.
Key
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Arm 1 Tacrolimus (TAC) TCD601 administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). Arm 1 Corticosteroids (CS) TCD601 administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). Arm 1 Mycophenolate Mofetil (MMF) TCD601 administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). Arm 2 Tacrolimus (TAC) TCD601 administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). Arm 2 Corticosteroids (CS) TCD601 administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). Arm 2 Mycophenolate Mofetil (MMF) TCD601 administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). Arm 3 Tacrolimus (TAC) ATG administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). Arm 3 Corticosteroids (CS) ATG administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). Arm 3 Mycophenolate Mofetil (MMF) ATG administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). Arm 3 ATG ATG administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). Arm 1 TCD601 TCD601 administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS). Arm 2 TCD601 TCD601 administered with the standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0. 12 months Measure Peak Plasma Concentration (Cmax) Over Time. 12 months The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration.
Measure the Area Under the Plasma Concentration Versus Time Curve (AUC). 12 months The AUC from time zero to the last measurable concentration sampling time.
- Secondary Outcome Measures
Name Time Method The Incidence of Rejection at 12 Months Post-transplant. 12 months The incidence of treated biopsy-proven acute rejection (tBPAR) and antibody medication rejection (AMR) at 12 months post-transplant.
To Assess the Change in Renal Function Over Time. 12 months Estimated glomerular filtration rate (eGFR) was calculated using the MDRD4 equation. Mean+-SD eGFR values are presented at 3, 6, and 12. and compared against baseline (1 Month post-transplant).
Trial Locations
- Locations (4)
Emory University
🇺🇸Atlanta, Georgia, United States
Kansas University Medical Center
🇺🇸Kansas City, Kansas, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Saint Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
Emory University🇺🇸Atlanta, Georgia, United States