NCT07835581

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
620

participants targeted

Target at P75+ for phase_3

Timeline
78mo left

Started Oct 2026

Longer than P75 for phase_3

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 23, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2033

Last Updated

September 30, 2026

Status Verified

September 1, 2026

Enrollment Period

2.4 years

First QC Date

September 16, 2026

Last Update Submit

September 25, 2026

Conditions

Kidney Transplant Rejection

Keywords

AT-1501Kidney TransplantRenal Allograft RejectionProphylaxisCD40L InhibitorHumanized blocking antibody to CD40Lmonoclonal antibodyrenaltransplantESRDtegoprubart

Outcome Measures

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

    12 months post-transplant

Secondary Outcomes (9)

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

    12 months post-transplant

  • Participant and graft survival

    12 months post-transplant

  • iBox score at 12 months post-transplant survival

    12 months post-transplant

  • Mean Renal graft function as assessed by estimated glomerular filtration rate

    12 months post-transplant

  • Incidence of new-onset diabetes after transplantation

    12 months post-transplant

  • +4 more secondary outcomes

Study Arms (2)

Investigative Arm

EXPERIMENTAL

Tegoprubart

Drug: Tegoprubart

Comparator Arm

ACTIVE COMPARATOR

Tacrolimus

Drug: Tacrolimus

Interventions

TegoprubartDRUG

Tegoprubart administered via IV infusion

Also known as: AT-1501
Investigative Arm
TacrolimusDRUG

Tacrolimus administered orally

Comparator Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Central Study Contacts

Eledon Main Contact

CONTACT

949-238-8090clinicaltrials@eledon.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2026

First Posted

September 23, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2033

Last Updated

September 30, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share