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

RecruitingPhase 1, Phase 2Ages 18 Years - 100 YearsAllEledon Pharmaceuticals
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Male or female ≥ 18 years of age 2. Recipient of their first kidney transplant from a living or deceased donor 3. Agree to comply with contraception requirements during and for at least 90 days after the last administration of study drug Exclusion Criteria: 1. Induction therapy, other than study assigned rATG, planned as part of initial immunosuppressive regimen 2. Currently treated with any systemic immunosuppressive regimen, including immunologic biologic therapies, with the exception of 5 mg prednisone or equivalent daily; 3. Previous treatment with AT 1501 or any other anti CD40LG therapy 4. The patient has previously received a bone marrow transplant or any other solid organ transplant, including a kidney, or will be undergoing a multi organ or dual kidney transplant 5. Will receive a kidney with an anticipated cold ischemia time of \> 30 hours; 6. Will receive a kidney from a donor that meets any of the following criteria: * Donation after Cardiac Death (DCD) criteria; or * Extended Criteria Donor (ECD) criteria, defined as: * Is blood group (ABO) incompatible; or * Age ≥ 60 years; or Age 50-59 years with any 2 of the following criteria: * Death due to cerebrovascular accident * History of hypertension * Terminal creatinine ≥ 133 μmol/L (1.5 mg/dL) 7. Human leukocyte antigen identical (two haplotype match or zero HLA mismatch) donor 8. Medical conditions that require chronic use of systemic steroids at a dose higher than 5 mg prednisone or equivalent per day 9. History of a TE event, known hypercoagulable state, or condition requiring long term anticoagulation: 10. Positive T- or B-cell crossmatch that is due to HLA antibodies or presence of a DSA at Screening
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What it tests

  • AT-1501
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Where

9 sites
University of Cincinnati
Cincinnati, United States
Royal Prince Alfred Hospital
Camperdown, Australia
Royal Adelaide Hospital
Adelaide, Australia
Fundação Oswaldo Ramos - Hospital do Rim
São Paulo, Brazil
Providence Health Care - St. Paul's Hospital
Vancouver, Canada
Vancouver General Hospital
Vancouver, Canada
McGill University Health Care Centre
Montreal, Canada
Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital
Liverpool, United Kingdom

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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