Evaluating AT 1501 for kidney transplant patients
A Phase 1b, Multicenter, Open Label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant
This study is testing if a new treatment called AT 1501 can help prevent kidney transplant rejection in patients getting their first transplant.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Eledon Pharmaceuticals Industry-sponsored |
| Drugs / interventions | prednisone |
| Locations | 9 sites (Cincinnati, Ohio and 8 other locations) |
| Trial ID | NCT05027906 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, pharmacokinetics, and efficacy of AT 1501 in patients undergoing their first kidney transplant. Up to 24 participants will receive AT-1501 alongside rATG induction therapy and maintenance with corticosteroids and mycophenolate. The goal is to assess how well this treatment can prevent renal allograft rejection in these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are receiving their first kidney transplant.
Not a fit: Patients who have previously received a kidney transplant or are undergoing multi-organ transplants will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve kidney transplant outcomes by reducing the risk of organ rejection.
How similar studies have performed: Other studies have explored CD40L inhibitors in transplant settings, showing promise, but this specific approach with AT 1501 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cincinnati, Ohio and 8 other locations
- University of Cincinnati — Cincinnati, Ohio, United States (Recruiting)
- Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia (Recruiting)
- Royal Adelaide Hospital — Adelaide, South Australia, Australia (Recruiting)
- Fundação Oswaldo Ramos - Hospital do Rim — São Paulo, Brazil (Recruiting)
- Providence Health Care - St. Paul's Hospital — Vancouver, British Columbia, Canada (Recruiting)
- Vancouver General Hospital — Vancouver, British Columbia, Canada (Recruiting)
- McGill University Health Care Centre — Montreal, Quebec, Canada (Recruiting)
- Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital — Liverpool, United Kingdom (Recruiting)
- Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital — Oxford, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Eledon Pharmaceuticals
- Email: clinicaltrials@eledon.com
- Phone: 949-238-8090
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.