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

Overview

About this study

The purpose of this study is to evaluate the long term safety and efficacy of AT-1501 (tegoprubart) compared with tacrolimus in patients undergoing kidney transplantation.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 08/16/2024. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Andrew Bentall

Closed for enrollment

Contact information:

Julie Gecox Hanson

Gecox.Julie@mayo.edu

More information

Publications

Publications are currently not available