The primary objective is to investigate the safety 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)
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.
Single group
TNX-1500
DrugThis is an open-label, single-center, single-arm study to assess the safety of TNX-1500, an Fc-modified anti-DF154 mAb in five adult kidney transplant recipients.
Kidney Transplant
Procedure/SurgeryKidney Transplant
Number of Adverse Events in each subject
The primary endpoint is the cumulative incidence of all AEs and SAEs in subjects treated with TNX-1500 at 12-months (Day 364, Week 52).
Number of Serious Adverse Events in each subject
The primary endpoint is the cumulative incidence of all AEs and SAEs in subjects treated with TNX-1500 at 12-months (Day 364, Week 52).
Incidence of Biopsy Proven Acute Rejection
Acute rejection, treatment and outcome biopsy pathology grading (Banff Criteria)
Incidence of treatment for acute rejection
Acute rejection, treatment and outcome biopsy pathology grading (Banff Criteria)
Incidence of de novo DSA development
Incidence of serious opportunistic infections
based upon AE/SAE data and available quantitative and qualitative EBV and CMV surveillance data
Click on the lead sponsor to view all of their trials.
Ayman Al Jurdi, MD
Lead sponsor
Massachusetts General Hospital
Sponsor institution
Tonix Pharmaceuticals, Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
