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.
Who Can Participate?
Eligibility
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 Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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).
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
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
Kadiyala
Ravindra
Protocol Number
PRO00116051
NCT ID
NCT06126380
Phase
II
Enrollment Status
Pending Open to Enrollment