A Phase 3 interventional study of Tegoprubart and Tacrolimus in Kidney Transplant Rejection, sponsored by Eledon Pharmaceuticals. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Eledon Pharmaceuticals · Phase 3, Interventional, and Treatment
This study will evaluate the efficacy and safety of tegoprubart compared with tacrolimus in adult participants undergoing first kidney transplantation.
This is a multicenter, randomized, active-controlled, open-label study to assess the efficacy and safety of tegoprubart compared with tacrolimus as part of an immunosuppressive regimen in adult participants undergoing first kidney transplantation. Dose regimens will include either tegoprubart (AT-1501) or tacrolimus.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's planned enrollment of 620 is above the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Eledon Pharmaceuticals is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tegoprubart
Drug: Tegoprubart
Tacrolimus
Drug: Tacrolimus
Tegoprubart administered via IV infusion
Also known as: AT-1501
Tacrolimus administered orally
Efficacy failure rate at 12 months post-transplant, defined as the first occurrence of biopsy proven acute rejection, graft loss, or death
Time frame: 12 months post-transplant
Proportion of participants with for-cause biopsy proven acute rejection, graft loss, or death
Time frame: 12 months post-transplant
Participant and graft survival
Time frame: 12 months post-transplant
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.
Time frame: 12 months post-transplant
Mean Renal graft function as assessed by estimated glomerular filtration rate
Time frame: 12 months post-transplant
Incidence of new-onset diabetes after transplantation
Time frame: 12 months post-transplant
Incidence of new or worsening hypertension
Time frame: 12 months post-transplant
Incidence of new or worsening hyperlipidemia
Time frame: 12 months post-transplant
Proportion of participants experiencing deterioration on Patient Reported Outcomes
Time frame: 12 months post-transplant
Incidence of delayed graft function
Time frame: Initial post-transplant period
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tegoprubart
Eledon Pharmaceuticals