Summary

Eligibility
for people ages 18-100 (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

Summary

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

Official Title

AT-1501-K209: BESTOW-EXTENSION: a Phase 2, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients

Details

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 function after kidney transplantation.

The number of patients enrolled for OLE study will depend on the enrollment in the Parent studies. To be eligible for participation in this study, participants must have completed a designated Parent study.

Participants in this study will continue the treatment regimen they were receiving in the Parent study. Dose regimens will include either AT-1501 (tegoprubart) or tacrolimus.

Keywords

Kidney Transplant Rejection, Kidney Transplant, AT-1501, Renal Allograft Rejection, Prophylaxis, CD40L Inhibitor, Humanized blocking antibody to CD40L, monoclonal antibody, renal, transplant, ESRD, tegoprubart, Tacrolimus

Eligibility

You can join if…

Open to people ages 18-100

  • 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.

You CAN'T join if...

  • 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.

Locations

  • University of California Los Angeles
    Los Angeles California 90024 United States
  • St. Paul's Hospital
    Vancouver British Columbia V6Z IY6 Canada

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Eledon Pharmaceuticals
ID
NCT06126380
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 132 study participants
Last Updated