Phase II Clinical Trial Evaluating the Safety and Efficacy of Fc-Modified Anti-CD154 mAB (TNX-1500) in Kidney Transplant Recipients
Ayman Al Jurdi, MD
Summary
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.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female subjects ≥18 to 75 years of age. 2. 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. 3. Recipient of an ABO-compatible, non-human leukocyte antigen (HLA) identical living or deceased donor kidney (de novo or second transplant) 4. Ability to understand the study requirements and provide written informed consent. 5. Epstein-Barr virus (EBV) seropositive Exclusion Criteria: 1. Recipient seropositive for human immunodeficiency viru…
Interventions
- DrugTNX-1500
This is an open-label, single-center, single-arm study to assess the safety and efficacy of TNX-1500, an Fc-modified anti-DF154 mAb in five adult kidney transplant recipients.
- ProcedureKidney Transplant
Kidney Transplant
Locations (2)
- Massachusetts General HospitalBoston, Massachusetts
- Massachusetts General HospitalBoston, Massachusetts