This is an open-label, single-institution study to assess the safety and the efficacy of the Sip-Tego regimen for the induction of donor-specific immunologic unresponsiveness to a renal allograft. The investigators propose to treat 6 adult subjects in end-stage renal disease (ESRD) who do not demonstrate evidence of prior sensitization.
Male or female 18-65 years of age.
Subjects with chronic kidney disease stage V (GFR<15ml/min/1.73m2) or ESRD who are treated or imminently be treated with either hemodialysis or peritoneal dialysis.
Candidate for a living-donor renal allograft from an HLA matched or mismatched donor
First or second renal transplant.
ABO blood group-incompatible renal allograft
Participant with a donor-specific antibody (DSA) within 6 months prior to transplant
Persistent Leukopenia (WBC less than 2,000/mm3) or thrombocytopenia (<100,000/mm3)
Seropositivity for HIV-1, hepatitis B core antigen, or hepatitis C virus (confirmed by hepatitis C virus RNA); or positivity for hepatitis B surface antigen.
Tatsuo Kawai, MD, PhD
Lead sponsor
Massachusetts General Hospital
Sponsor institution
Eledon Pharmaceuticals
Collaborator
ITB-Med LLC
Collaborator