BESTOW-EXTENSION: A Phase 2, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients (BESTOW-EXTENSION)

Research summary

This is a multicenter, open-label, active control extension study to assess the long-term safety and efficacy of tegoprubart compared with tacrolimus in the preservation of allograft function after kidney transplantation. To be eligible for participation in this study, participants must have completed a designated Parent study. Qualification for this open-label extension (OLE) study will be specified in the Parent study Protocol. Participants who discontinue treatment early or discontinue from the Parent study are not eligible for this OLE study AT-1501-K209. Prospective participants will be consented into the OLE separately from the Parent study, and the Informed Consent Form (ICF) should be signed prior to initiating any of the activities for this study. The End of Treatment visit for the Parent study will also serve as the Baseline visit for Study AT-1501-K209, where the first dose of K209 study medications will be administered. Participants in this study will continue the treatment regimen they were receiving (including any refinements to other regimen components) in the Parent study.

Principal Investigator

Dr Paul Harden

Contact us

Email: renalandtransplanttrials@ouh.nhs.uk

IRAS number

1009614