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Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients - Bestow Extension - Clinical Trial

What is the Purpose of this Study?

We are doing this study to assess the long-term safety of an experimental drug called tegoprubart (the study drug) when it is given in combination with a standard immunosuppressive medicine, mycophenolate or mycophenolic acid, after a kidney transplant. The study will also look at the function and health of the implanted kidney and will assess how well the study drug can lower the risk of diabetes and transplant rejection.

What is the Condition Being Studied?

Maintenance Following Kidney Transplant

Who Can Participate in the Study?

Adults ages 18+ who participated in a 1-year study of the safety and efficacy of tegoprubart for kidney transplant recipients (parent study).

The parent study at Duke is: Pro00113009 - A Phase 2, Multicenter, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation [BESTOW]

For more information, contact the study team at jerry.turner@duke.edu.

Age Group
Adults

What is Involved?

Participants who participated in the parent study (BESTOW) and choose to participate in this extension study will continue with the same drug regimen they were receiving in the parent study for an additional 48 months (around 4 years).

Study Details

Full Title
BESTOW-EXTENSION: A Phase 2, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients
Principal Investigator
Kidney/Pancreas Transplant Surgeon
Protocol Number
IRB: PRO00116051
NCT: NCT06126380
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment Soon