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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
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.
Kidney Transplant
Massachusetts General Hospital
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
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).
Time frame: 12 Months
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).
Time frame: 12 Months
Incidence of Biopsy Proven Acute Rejection
Acute rejection, treatment and outcome biopsy pathology grading (Banff Criteria)
Time frame: 12 months
Incidence of treatment for acute rejection
Acute rejection, treatment and outcome biopsy pathology grading (Banff Criteria)
Time frame: 12 Months
Incidence of de novo DSA development
Time frame: Months 1, 3, 6, 9, 12
Incidence of serious opportunistic infections and malignancies
based upon AE/SAE data and available quantitative and qualitative EBV and CMV surveillance data
Time frame: 12 months
GFR measurement
Assessment of renal function through the estimated glomerular filtration rate at 12 months post-transplant
Time frame: 12 months
Incidence of death
Time frame: 12 months
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Incidence of graft loss
Time frame: 12 months
Degree of Proteinuria
Proteinuria by urine protein-to-creatinine ratio
Time frame: 12 Months
Degree of albuminuria
Albuminuria by urine microalbumin-to-creatinine ratio
Time frame: 12 Months