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

Launched by ELEDON PHARMACEUTICALS · Aug 25, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called AT 1501 to see how safe it is, how the body processes it, and how effective it is for patients who are receiving a kidney transplant. The trial is currently looking for participants aged 18 and older who are about to have their first kidney transplant from either a living or deceased donor. To be eligible, participants need to agree to use contraception during the study and for at least 90 days after the last dose of the medication.

If you decide to join this trial, you will be monitored closely for any side effects and how well the medication works for you. It's important to know that there are certain conditions that might exclude someone from participating, such as having received other specific treatments before or needing a kidney transplant from certain types of donors. Overall, this trial aims to help improve kidney transplant outcomes and ensure that new medications like AT 1501 are safe for patients.

Gender

ALL

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:
• • • 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
• • 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:
• • 1. Patients with a history of clotted venous access not requiring long term anticoagulation may be included at the Investigator's discretion if have no other history of TE events or known hypercoagulable state