Prevention of Rejection in Kidney Transplant
Conditions
Keywords
Kidney Transplant, Renal Allograft Rejection, Prophylaxis, AT-1501, CD40L inhibitor, Humanized blocking antibody to CD40L, Monoclonal Antibody, Renal, Transplant, ESRD, tegoprubart
Brief summary
This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation.
Detailed description
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.
Interventions
DRUGAT-1501
Investigative Arm
Sponsors
Eledon Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
None ( Open Label)
Intervention model description
Phase 1b, open label, single-arm study
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Incidences | Through study completion, an average up to 20 months | Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and Adverse Events of Special Interest (AESIs) |
| Pharmacokinetic- PK profile | Day 1 and at steady state Month 3 | PK profile of the first dose of AT 1501 and at steady state Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (Ct), calculated using noncompartmental analysis (AUC0-t) |
| Pharmacokinetic- Area under the plasma concentration | Day 1 and at steady state Month 3 | Area under the plasma concentration versus time curve from time 0 extrapolated to infinity, calculated using noncompartmental analysis (AUC0-inf) |
| Pharmacokinetic- Cmax | Day 1 and at steady state Month 3 | Maximum observed plasma concentration (Cmax) |
| Pharmacokinetic- Tmax | Day 1 and at steady state Month 3 | Time to reach maximum observed plasma concentration (Tmax) |
| Pharmacokinetic- Ke | Day 1 and at steady state Month 3 | Terminal elimination rate constant (Ke) |
| Pharmacokinetic- (t1/2) | Day 1 and at steady state Month 3 | Terminal phase half-life (t1/2) |
| Pharmacokinetic- CL | Day 1 and at steady state Month 3 | Clearance (CL) |
| Pharmacokinetic- (Vdss) | Day 1 and at steady state Month 3 | Volume of distribution at steady state (Vdss) |
Countries
Australia, Brazil, Canada, United Kingdom, United States
Contacts
Primary ContactEledon Pharmaceuticals
Outcome results
None listed