NCT05027906 Safety, Pharmacokinetics, and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant
| NCT ID | NCT05027906 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Eledon Pharmaceuticals |
| Condition | Prevention of Rejection in Kidney Transplant |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2022-02-18 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 48 participants in total. It began in 2022-02-18 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05027906 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Prevention of Rejection in Kidney Transplant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05027906 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05027906 currently recruiting?
Yes, NCT05027906 is actively recruiting participants. Contact the research team at clinicaltrials@eledon.com for enrollment information.
Where is the NCT05027906 trial being conducted?
This trial is being conducted at Cincinnati, United States, Camperdown, Australia, Adelaide, Australia, São Paulo, Brazil and 5 additional locations.
Who is sponsoring the NCT05027906 clinical trial?
NCT05027906 is sponsored by Eledon Pharmaceuticals. The trial plans to enroll 48 participants.
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