Last updated 13 months ago
Safety, Pharmacokinetics, and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant
48 patients around the world
Available in Brazil, United States
This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation. Up to 48 de novo kidney transplant recipients will receive AT-1501 in combination with rATG induction with corticosteroids (CS), and mycophenolate as maintenance therapy.
Eledon Pharmaceuticals
1Research sites
48Patients around the world
This study is for people with
Kidney Transplant
Requirements for the patient
To 100 Years
All Gender
Medical requirements
- 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.
- 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.Donation after Cardiac Death (DCD) criteria.Extended Criteria Donor (ECD) criteria, defined as.Is blood group (ABO) incompatible.Age ≥ 60 years.Age 50-59 years with any 2 of the following criteria.Death due to cerebrovascular accident.History of hypertension.Terminal creatinine ≥ 133 μmol/L.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.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.
Sites
Hospital do Rim - HRIM– Fundação Oswaldo Ramos
Recruiting
SponsorEledon Pharmaceuticals
Study typeInterventional
Conditions
Kidney Transplant
Requirements
To 100 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05027906
