Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients
About
Brief Summary
This study will evaluate the long term safety and efficacy of AT-1501 (tegoprubart) compared with tacrolimus in patients undergoing kidney transplantation.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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.
Join this Trial
Enrolling by Invitation
These studies are not open to everyone who meets the eligibility criteria, but
only to people in that particular population, who are specifically invited to participate.
Study Stats
Protocol No.
24-5298
Category
Genitourinary Disorders
Immune System/Transplant Related Disorders
Principal Investigator
Contact
Location
- UCLA Westwood