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NCT Number: NCT07835581

Phase 3 Randomized Study of Tegoprubart Efficacy and Safety Compared With Tacrolimus in Kidney Transplantation

This study will evaluate the efficacy and safety of tegoprubart compared with tacrolimus in adult participants undergoing first kidney transplantation.

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Key information

Conditions

Kidney Transplant Rejection Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Tegoprubart

Drug

Tegoprubart administered via IV infusion

Other names: AT-1501

Tacrolimus

Drug

Tacrolimus administered orally

Primary outcomes

  1. 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

Secondary outcomes

  1. Proportion of participants with for-cause biopsy proven acute rejection, graft loss, or death

    Time frame: 12 months post-transplant

  2. Participant and graft survival

    Time frame: 12 months post-transplant

  3. Composite risk-prediction score for kidney allograft survival

    Time frame: 12 months post-transplant

  4. Mean Renal graft function as assessed by estimated glomerular filtration rate

    Time frame: 12 months post-transplant

  5. Incidence of new-onset diabetes after transplantation

    Time frame: 12 months post-transplant

  6. Incidence of new or worsening hypertension

    Time frame: 12 months post-transplant

  7. Incidence of new or worsening hyperlipidemia

    Time frame: 12 months post-transplant

  8. Proportion of participants experiencing deterioration on Patient Reported Outcomes

    Time frame: 12 months post-transplant

  9. Incidence of delayed graft function

    Time frame: Initial post-transplant period

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Eledon Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: LEGACY

Important dates

Study start
2026
Primary completion
2029
Study completion
2033
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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