Kidney Transplant Rejection
Conditions
Keywords
AT-1501, Kidney Transplant, Renal Allograft Rejection, Prophylaxis, CD40L Inhibitor, Humanized blocking antibody to CD40L, Monoclonal Antibody, Renal, Transplant, ESRD, Tegoprubart
Brief summary
This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation.
Detailed description
This study is a randomized, multicenter, open-label, active control study to evaluate the safety and efficacy of AT-1501 compared with tacrolimus in the prevention of rejection in patients undergoing kidney transplantation. Up to 120 de novo kidney transplant recipients will receive rATG induction with corticosteroids (CS), and mycophenolate as maintenance therapy, and will be randomized 1:1 to receive either AT-1501 or tacrolimus.
Interventions
DRUGAT-1501
IV infusions of AT-1501 20 mg/kg over 1 hour.
DRUGTacrolimus
Tacrolimus will be administered BID, targeting a whole blood trough concentration of 6-12 ng/mL until Month 6, and 6-8 ng/mL thereafter.
Sponsors
Eledon Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Currently treated with corticosteroids other than topical or inhaled corticosteroids * 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: * 5a. Donation after Cardiac Death (DCD) criteria; Or * 5b. Kidney Donor Profile Index (KDPI) of \> 85%; Or * 5c. Is blood group (ABO) incompatible * Medical conditions that require chronic use of systemic corticosteroids or other immunosuppressants * History of a thromboembolic event, known hypercoagulable state, or condition requiring long term anticoagulation * 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 |
|---|---|---|
| eGFR at 12 months | Assessed from date of transplant through Day 364 (Month 12) | Estimated Glomerular Filtration Rate (eGFR) at 12 months post-transplant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NODAT at 12 months post-transplant | Assessed from date of transplant through Day 364 (Month 12 | The proportion of new onset diabetes after transplant (NODAT) at 12 months post-transplant |
| The proportion of patient and graft survival at 12 months post-transplant | Assessed from date of transplant through Day 364 (Month 12) | Patient and graft survival are defined as either A) Death, B) re-transplantation or C) Requirement for regular dialysis |
| BPAR-free patient and graft survival at 12 months post-transplant | The proportion of BPAR-free patient and graft survival at 12 months post-transplant | Assessed from date of transplant through Day 364 (Month 12) |
| BPAR at 12 months | Assessed from date of transplant through Day 364 (Month 12) | The proportion of BPAR at 12 months |
Countries
Australia, Brazil, Canada, France, Germany, Spain, United States
Outcome results
None listed