RecruitingPhase 1Phase 2NCT05027906

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

A Phase 1b, Multicenter, Open Label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant


Sponsor

Eledon Pharmaceuticals

Enrollment

48 participants

Start Date

Feb 18, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a new drug called AT 1501, which works differently from standard anti-rejection medications used after kidney transplants. It targets a specific immune pathway to prevent the body from attacking the new kidney, and researchers are studying whether it is safe and effective when added to standard care. **You may be eligible if...** - You are 18 or older - You are receiving your first kidney transplant from a living or deceased donor - You agree to use contraception during and for 90 days after taking the study drug **You may NOT be eligible if...** - You have previously had a bone marrow transplant or any other organ transplant - You are receiving a multi-organ or dual kidney transplant - You have already been treated with immunosuppressive medications (other than low-dose prednisone) - The donated kidney is expected to be stored in ice for more than 30 hours - The donor kidney comes from an extended criteria donor (older age with specific health conditions) or donation after cardiac death Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAT-1501

Investigative Arm


Locations(9)

University of Cincinnati

Cincinnati, Ohio, United States

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Fundação Oswaldo Ramos - Hospital do Rim

São Paulo, Brazil

Providence Health Care - St. Paul's Hospital

Vancouver, British Columbia, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

McGill University Health Care Centre

Montreal, Quebec, Canada

Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital

Liverpool, United Kingdom

Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital

Oxford, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05027906