Study of Tegoprubart Efficacy and Safety Compared With Tacrolimus in Kidney Transplantation (LEGACY)

Eledon Pharmaceuticals

Status and phase: Not yet enrolling; Phase 3

Conditions: Kidney Transplant Rejection

Treatments: Drug: Tegoprubart; Drug: Tacrolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT07835581

2026-528156-15-00 (EU Trial (CTIS) Number)

U1111-1346-1557 (Other Identifier)

AT-1501-K301

Details and patient eligibility

About

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

Full 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.

Enrollment: 620 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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620 participants in 2 patient groups

Investigative Arm

Experimental group

Description:

Tegoprubart

Treatment:

Drug: Tegoprubart

Comparator Arm

Active Comparator group

Description:

Tacrolimus

Treatment:

Drug: Tacrolimus