About this trial
This study will evaluate the efficacy and safety of tegoprubart compared with tacrolimus in adult participants undergoing first kidney transplantation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Undergoing kidney transplant with a living or deceased donor kidney
Adult participants that have reached the age of consent and are ≥18 years of age
Written informed consent prior to any study assessment
Disqualifiers
Conditions or circumstances that, in the investigator's judgment or according to protocol-defined criteria, would make participation unsafe, interfere with study assessments, or compromise protocol compliance.
Trial design
Parallel
Treatments tested in this trial
Tegoprubart
DrugTegoprubart administered via IV infusion
Tacrolimus
DrugTacrolimus administered orally
Treatment groups
Trial outcomes
Primary outcomes
Efficacy failure rate at 12 months post-transplant, defined as the first occurrence of biopsy proven acute rejection, graft loss, or death
Secondary outcomes
Proportion of participants with for-cause biopsy proven acute rejection, graft loss, or death
Participant and graft survival
iBox score at 12 months post-transplant survival
iBox is the validated tool for predicting the risk of kidney transplant loss based on artificial intelligence. Range of score is 0%-100%, higher score indicates better kidney survival.
Mean Renal graft function as assessed by estimated glomerular filtration rate
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: