Safety, Pharmacokinetics, and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant
Recruiting now · Phase 1/Phase 2
Conditions studied: Prevention of Rejection in Kidney Transplant
In brief
This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation.
Key facts
- Study ID
- NCT05027906
- Run by
- Eledon Pharmaceuticals
- People needed
- 48
- Starts
- 2022-02-18
- Expected to finish
- 2027-01-01
- Last updated by the study team
- 2025-06-29
Who can join
Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female ≥ 18 years of age
- Recipient of their first kidney transplant from a living or deceased donor
- Agree to comply with contraception requirements during and for at least 90 days after the last administration of study drug
You may not qualify if…
- Induction therapy, other than study assigned rATG, planned as part of initial immunosuppressive regimen
- Currently treated with any systemic immunosuppressive regimen, including immunologic biologic therapies, with the exception of 5 mg prednisone or equivalent daily;
- Previous treatment with AT 1501 or any other anti CD40LG therapy
- 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
- Will receive a kidney with an anticipated cold ischemia time of > 30 hours;
- 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)
- Human leukocyte antigen identical (two haplotype match or zero HLA mismatch) donor
- Medical conditions that require chronic use of systemic steroids at a dose higher than 5 mg prednisone or equivalent per day
- History of a TE event, known hypercoagulable state, or condition requiring long term anticoagulation:
- Positive T- or B-cell crossmatch that is due to HLA antibodies or presence of a DSA at Screening
Where it is running
- University of Cincinnati — Cincinnati, Ohio, United States (enrolling)
- Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia (enrolling)
- Royal Adelaide Hospital — Adelaide, South Australia, Australia (enrolling)
- Fundação Oswaldo Ramos - Hospital do Rim — São Paulo, Brazil (enrolling)
- Providence Health Care - St. Paul's Hospital — Vancouver, British Columbia, Canada (enrolling)
- Vancouver General Hospital — Vancouver, British Columbia, Canada (enrolling)
- McGill University Health Care Centre — Montreal, Quebec, Canada (enrolling)
- Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital — Liverpool, United Kingdom (enrolling)
- Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital — Oxford, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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