Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation
Study Details
Study Description
Brief Summary
This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Investigative AT-1501 monoclonal antibody targeting CD40L given as an IV infusion |
Drug: AT-1501
IV infusions of AT-1501 20 mg/kg over 1 hour.
Other Names:
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Active Comparator: Comparator Tacrolimus administered BID, targeting a whole blood trough concentration of 6-12 ng/mL until Month 6, and 6-8 ng/mL thereafter |
Drug: Tacrolimus
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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female ≥ 18 years of age
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Recipient of their first kidney transplant from a living or deceased donor
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Agree to comply with contraception requirements during and for at least 90 days after the last administration of study drug
Exclusion Criteria:
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Induction therapy, other than study assigned rATG, planned as part of initial immunosuppressive regimen
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Currently treated with any systemic immunosuppressive regimen, including immunologic biologic therapies
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Currently treated with corticosteroids other than topical or inhaled corticosteroids
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Will receive a kidney with an anticipated cold ischemia time of > 30 hours
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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 6. Medical conditions that require chronic use of systemic corticosteroids or other immunosuppressants 7. History of a thromboembolic event, known hypercoagulable state, or condition requiring long term anticoagulation 8. Positive T- or B-cell crossmatch that is due to HLA antibodies or presence of a DSA at Screening
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Washington University in St. Louis | Saint Louis | Missouri | United States | 63110 |
2 | Virginia Commonwealth University | Richmond | Virginia | United States | 23298 |
Sponsors and Collaborators
- Eledon Pharmaceuticals
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AT-1501-K207
- 2023-503336-41-00
- U1111-1278-5225