(TNX-1500) in Kidney Transplant Recipients (NCT07204080) | Clinical Trial Compass
Not Yet RecruitingPhase 2
(TNX-1500) in Kidney Transplant Recipients
United States5 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. Epstein-Barr virus (EBV) seropositive
Exclusion criteria
✕. 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.
✕. Pregnant or nursing (lactating) women confirmed by human chorionic gonadotropin (hCG) laboratory test.
✕. Women of childbearing potential (women capable of becoming pregnant) unless using a highly effective method of contraception during dosing and for 24 weeks after study treatment. Highly effective contraception methods include:
✕. Female sterilization (surgical, bilateral oophorectomy with or without hysterectomy), or tubal ligation at least 6 weeks before taking study treatment.
✕. Male sterilization (at least 6 months prior to screening); for female subjects on the study, the vasectomized male partners should be the sole partners for that subject.