Purpose of this Study
In this study, people will be placed into one of three groups by chance. Two groups will receive a study medicine called VEL 101, which is given as a shot under the skin every two weeks. The third group will receive a standard medicine called tacrolimus, which is taken by mouth twice each day. The study will last about 12 to 14 months, depending on the group. Participants will have up to 26 visits during the study. At these visits, doctors will do blood tests, urine tests, heart checks, physical exams, and ask questions about how the person is feeling.
Who Can Participate?
Eligibility
People can join this study if they are adults who are 18 years old or older and have received a kidney transplant. They must also be up to date on their vaccinations so they are protected from common illnesses.
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
This study is testing a new medicine called VEL 101 in people who have had a kidney transplant. Researchers want to find out if this medicine is safe, easy for the body to handle, and works well. They will also study how the body absorbs the medicine, how it breaks it down, and how it uses it. This information helps doctors understand how the medicine works inside the body. The medicine is still being tested and has not yet been approved by the FDA.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Phase 2, randomized, partially blinded, controlled, dose ranging study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of VEL-101 in kidney transplant recipients. (RENGEVITY-201)
Principal Investigator
Allan
Kirk
Protocol Number
PRO00119645
NCT ID
NCT07290777
Phase
II
Enrollment Status
Pending Open to Enrollment