Kidney Transplant RejectionPhase 3LEGACYNCT07835581
Study of Tegoprubart Efficacy and Safety Compared With Tacrolimus in Kidney Transplantation
A Phase 3 study testing Tegoprubart and Tacrolimus in people with Kidney Transplant Rejection, run by Eledon Pharmaceuticals.
Trial summary
This study will evaluate the efficacy and safety of tegoprubart compared with tacrolimus in adult participants undergoing first kidney transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Rejection
- What is being tested?
- Tegoprubart and Tacrolimus
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 620 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Mar 2033
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Phase 3 Randomized, Active-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of Tegoprubart Compared With Tacrolimus in Adult Participants Undergoing De Novo Kidney Transplantation
This study will evaluate the efficacy and safety of tegoprubart compared with tacrolimus in adult participants undergoing first kidney transplantation.
Read the detailed description
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.
- Conditions
- Kidney Transplant Rejection
- Being tested
- Tegoprubart, Tacrolimus
- Keywords
- AT-1501, Kidney Transplant, Renal Allograft Rejection, Prophylaxis, CD40L Inhibitor, Humanized blocking antibody to CD40L, monoclonal antibody, renal, transplant, ESRD, tegoprubart
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TegoprubartDrug
Also called AT-1501
Tegoprubart administered via IV infusion
TacrolimusDrug
Tacrolimus administered orally
| Study group | Role | What they receive |
|---|---|---|
| Investigative Arm | Experimental | Tegoprubart Receives: Drug: Tegoprubart |
| Comparator Arm | Active comparator | Tacrolimus Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy failure rate at 12 months post-transplant, defined as the first occurrence of biopsy proven acute rejection, graft loss, or death
Measured: 12 months post-transplant
Secondary outcomes (9)
Proportion of participants with for-cause biopsy proven acute rejection, graft loss, or death
Measured: 12 months post-transplant
Participant and graft survival
Measured: 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.
Measured: 12 months post-transplant
Mean Renal graft function as assessed by estimated glomerular filtration rate
Measured: 12 months post-transplant
Incidence of new-onset diabetes after transplantation
Measured: 12 months post-transplant
Incidence of new or worsening hypertension
Measured: 12 months post-transplant
Incidence of new or worsening hyperlipidemia
Measured: 12 months post-transplant
Proportion of participants experiencing deterioration on Patient Reported Outcomes
Measured: 12 months post-transplant
Incidence of delayed graft function
Measured: Initial post-transplant period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionMar 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 620 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eledon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835581
- Sponsor's protocol ID
- AT-1501-K301
- Other IDs
- 2026-528156-15-00, U1111-1346-1557
- Acronym
- LEGACY
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase 3 Randomized, Active-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of Tegoprubart Compared With Tacrolimus in Adult Participants Undergoing De Novo Kidney Transplantation
- ClinicalTrials.gov ID
- NCT07835581
- Acronym / sponsor ID
- LEGACY / AT-1501-K301
- Conditions
- Kidney Transplant Rejection
- Keywords
- AT-1501, Kidney Transplant, Renal Allograft Rejection, Prophylaxis, CD40L Inhibitor, Humanized blocking antibody to CD40L, monoclonal antibody, renal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 620 participants (estimated)
- Lead sponsor
- Eledon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2033 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy and safety of tegoprubart compared with tacrolimus in adult participants undergoing first kidney transplantation.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigative Arm | Experimental | Drug: TegoprubartTegoprubart |
| Comparator Arm | Active comparator | Drug: TacrolimusTacrolimus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TegoprubartAlso: AT-1501Tegoprubart administered via IV infusion | Drug | Investigative Arm |
| TacrolimusTacrolimus administered orally | Drug | Comparator Arm |
Primary outcome
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
9 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tegoprubart and Tacrolimus in people with Kidney Transplant Rejection, run by Eledon Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eledon Main Contact (949-238-8090, clinicaltrials@eledon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.