Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients

• Status: Enrolling by invitation
• Trial end date: 2029-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the long term safety and efficacy of AT-1501 (tegoprubart) compared with tacrolimus in patients undergoing kidney transplantation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eledon Pharmaceuticals
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.