Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 100Years
All Genders
NCT05027906

Safety, Pharmacokinetics, and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant

Led by Eledon Pharmaceuticals · Updated on 2025-06-29

48

Participants Needed

9

Research Sites

254 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation.

CONDITIONS

Official Title

Safety, Pharmacokinetics, and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female 18 years of age or older
  • Recipient of their first kidney transplant from a living or deceased donor
  • Agree to use contraception during and for at least 90 days after the last dose of study drug
Not Eligible

You will not qualify if you...

  • Planned induction therapy other than study-assigned rATG
  • Currently treated with systemic immunosuppressive regimens except prednisone 5 mg or less daily
  • Previous treatment with AT 1501 or any anti CD40LG therapy
  • History of bone marrow transplant, any other solid organ transplant, multi-organ or dual kidney transplant
  • Receiving a kidney with expected cold ischemia time over 30 hours
  • Receiving kidney from donor meeting Donation after Cardiac Death or Extended Criteria Donor definitions
  • Receiving kidney from donor with blood group incompatibility or certain age and health criteria
  • Receiving kidney from a donor who is HLA identical (two haplotype match or zero mismatch)
  • Medical conditions requiring chronic steroids over 5 mg prednisone or equivalent daily
  • History of thromboembolic events, known hypercoagulable state, or requiring long-term anticoagulation
  • Positive T- or B-cell crossmatch due to HLA antibodies or donor-specific antibodies at screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 9 locations

1

University of Cincinnati

Cincinnati, Ohio, United States, 45267

Actively Recruiting

2

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia, 2050

Actively Recruiting

3

Royal Adelaide Hospital

Adelaide, South Australia, Australia, SA 5000

Actively Recruiting

4

Fundação Oswaldo Ramos - Hospital do Rim

São Paulo, Brazil

Actively Recruiting

5

Providence Health Care - St. Paul's Hospital

Vancouver, British Columbia, Canada, V6Z 1Y6

Actively Recruiting

6

Vancouver General Hospital

Vancouver, British Columbia, Canada, V6Z 1Y6

Actively Recruiting

7

McGill University Health Care Centre

Montreal, Quebec, Canada, H4A 3J1

Actively Recruiting

8

Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital

Liverpool, United Kingdom, L78XP

Actively Recruiting

9

Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital

Oxford, United Kingdom, OX3 9DU

Actively Recruiting

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Research Team

E

Eledon Pharmaceuticals

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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