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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
13
Investigational Product
Standard of Care Concomitant Immunosuppression
Standard of Care Concomitant Immunosuppression
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
Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0.
Time frame: 12 months
Measure Peak Plasma Concentration (Cmax) Over Time.
The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration.
Time frame: 12 months
Measure the Area Under the Plasma Concentration Versus Time Curve (AUC).
The AUC from time zero to the last measurable concentration sampling time.
Time frame: 12 months
The Incidence of Rejection at 12 Months Post-transplant.
The incidence of treated biopsy-proven acute rejection (tBPAR) and antibody medication rejection (AMR) at 12 months post-transplant.
Time frame: 12 months
To Assess the Change in Renal Function Over Time.
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).
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Standard of Care Concomitant Immunosuppression
Standard of Care induction therapy in solid organ transplantation