Status:
ENROLLING_BY_INVITATION
Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients
Lead Sponsor:
Eledon Pharmaceuticals
Conditions:
Kidney Transplant Rejection
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief Summary
This study will evaluate the long term safety and efficacy of AT-1501 (tegoprubart) compared with tacrolimus in patients undergoing kidney transplantation.
Detailed Description
This is a multicenter, open-label, active control extension study to assess the long-term safety and efficacy of AT-1501 (tegoprubart) compared with tacrolimus in the preservation of allograft functio...
Eligibility Criteria
Inclusion
- Successfully completed qualifying Parent study, where entry into the OLE was offered;
- Continue to be able to understand the key components of the study as described in the written ICF, and is willing and able to provide written informed consent;
- Agree not to participate in another interventional study while on treatment;
- If female, is surgically sterile or 2 years postmenopausal. Women of childbearing potential may be enrolled if a pregnancy test is negative at baseline. Women of childbearing potential and men with partners that are of childbearing potential must agree to use highly effective methods of contraception from baseline, through 90 days after the last administration of the study drug. Examples of acceptable methods of contraception are described in Table 6.
- If male, agree to use a medically accepted highly effective method of contraception and agree to use this method for 90 days after last administration of the study drug and agree to not donate sperm for 90 days after last administration of the study drug.
Exclusion
- Unwilling or unlikely to comply with the study requirements, in the opinion of the Investigator;
- Met any of the stopping criteria or discontinued study drug in the Parent study;
- Pregnant or breastfeeding.
Key Trial Info
Start Date :
October 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT06126380
Start Date
October 25 2023
End Date
December 1 2029
Last Update
December 10 2025
Active Locations (43)
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1
University of California Los Angeles
Los Angeles, California, United States, 90024
2
Keck School of Medicine of USC
Los Angeles, California, United States, 90033
3
University of California, Irvine Medical Center
Orange, California, United States, 92868
4
University of California, Davis Medical Center
Sacramento, California, United States, 95817