Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation (NCT05983770) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation
United States127 participantsStarted 2023-08-30
Plain-language summary
This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation.
Who can participate
Age range18 Years – 100 Years
SexALL
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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
What they're measuring
1
eGFR at 12 months
Timeframe: Assessed from date of transplant through Day 364 (Month 12)