Purpose of this Study
This study is for people receiving an organ transplant. Everyone in the study will receive standard medicines to help prevent the body from rejecting the new organ. Participants will be placed into one of three groups by chance. One group will receive a commonly used medicine called rATG, while the other two groups will receive a study medicine called siplizumab.
The study medicines are given through a vein during the hospital stay for the transplant. Treatment is given on the day of the transplant and for the next three days. Participants will also have physical exams, blood and urine tests, heart tests, and questionnaires. Researchers want to learn if siplizumab is safe and how well it works compared to the standard treatment for preventing organ rejection after transplant.
Who Can Participate?
Eligibility
People can join this study if they are adults between 18 and 70 years old who are receiving a kidney transplant from a living or deceased donor. The donor cannot be an exact tissue match. Participants cannot be receiving more than one organ transplant at the same time. They also cannot have cancer or infections such as tuberculosis, HIV, hepatitis B, or hepatitis C. Researchers are studying new ways to help prevent kidney transplant rejection while keeping patients safe.
Age Range
18-70
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 siplizumab in people who have end stage kidney disease and are receiving a kidney transplant. Researchers want to learn if siplizumab is safe and works as well as or better than a standard medicine called rATG, which is commonly used to help prevent the body from rejecting a new kidney.
Participants will receive either siplizumab or rATG along with other standard anti rejection medicines after their transplant. The goal is to find out which treatment is better at helping the body accept the transplanted kidney and keeping the kidney healthy after surgery.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Phase 2b, Randomized, Multicenter, Double-Blind, Dose-Finding, Active-Controlled Study of Siplizumab (TCD601) Compared to Rabbit Anti-Thymocyte Globulin in Renal
Transplant Recipients Requiring Induction Therapy and Receiving Standard of Care Immunosuppression with Tacrolimus, Mycophenolic Acid and Corticosteroids (MODERNIZE 1)
Transplant Recipients Requiring Induction Therapy and Receiving Standard of Care Immunosuppression with Tacrolimus, Mycophenolic Acid and Corticosteroids (MODERNIZE 1)
Principal Investigator
Allan
Kirk
Protocol Number
PRO00120258
Phase
II
Enrollment Status
Pending Open to Enrollment