The primary objective is to investigate the safety and efficacy of TNX-1500, an FC-modified anti-CD154 mAb, in five kidney transplant recipients at 12 months.
Male or female subjects ≥18 to 75 years of age.
Kidney transplant candidates with chronic kidney disease (stage IV or V) or end-stage kidney disease evaluated and listed for transplantation at Massachusetts General Hospital.
Recipient of an ABO-compatible, non-human leukocyte antigen (HLA) identical living or deceased donor kidney (de novo or second transplant)
Ability to understand the study requirements and provide written informed consent.
Recipient seropositive for human immunodeficiency virus (HIV-1), or hepatitis B surface antigen (HBsAg) or core antibody (Anti-HBc); subjects who are seropositive for hepatitis C virus (HCV) are excluded without proof of sustained viral response (SVR) after anti-HCV treatment or spontaneous clearance.
Recipient of a kidney from a donor who tests positive for HIV, HBsAg, Anti-HBc, or HCV NAT.
Subjects with a severe systemic infection, current or within the 2 weeks prior to screening.
Left ventricular ejection fraction < 40% as determined by TTE or clinical evidence of heart failure.
Ayman Al Jurdi, MD
Lead sponsor
Massachusetts General Hospital
Sponsor institution
Tonix Pharmaceuticals, Inc.
Collaborator