A Study of TCD601 in De Novo Renal Transplant Recipients (ASCEND)

People with de novo Renal Transplant Recipients are asked to participate in a research study being conducted by the Montefiore Medical Center.

You may be eligible to participate in this study if you:

• Are at least ≥18 and ≤70 years of age
• Are Epstein-Barr Virus (EBV) seropositive according to local practice
• Are recipient of an ABO compatible, non-HLA identical, de novo primary, living donor or deceased donor kidney transplant

You may not participate in this study if you:

• Are multi-organ transplant or tissue recipient
• Are recipient of a kidney from a donor after cardiac death
• Are recipient of high Kidney Donor Profile Index ≥85 (for deceased donor allograft recipients)
• Have received a replication-competent live vaccine within 4 weeks of screening
• Have severe systemic infections, current or within the two weeks prior to screening
• Are sero-positive for HIV or Hepatitis B Surface Antigen (HBsAg) and Hepatitis C virus
• Are pregnant or nursing (lactating) women
• Have history of malignancy of any organ system, except for localized excised non-melanomatous skin lesions or carcinoma in situ of the cervix
• Idiopathic FSGS, HUS/TTP, MPGN I or II as cause of end-stage renal disease (ESRD)

Contact Information
Harith Raees, Study Coordinator
Phone: (619) 888-9718
Email: HRAEES@MONTEFIORE.ORG

23-02-129