A Study Comparing Siplizumab With Rabbit Anti-Thymocyte Globulin to Help the Body Accept a Kidney Transplant
Condition(s) studied
Investigational drug(s) / intervention(s)
Siplizumab: A non-agonistic, humanized, anti-CD2 monoclonal antibody of the IgG1κ class
Rabbit anti-thymocyte globulin: An anti-human thymocyte immunoglobulin preparation made of purified polyclonal antibodies derived from rabbits
Study summary
The goal of this clinical trial is to learn if siplizumab can prevent rejection of a kidney transplant in adult participants with end stage kidney disease. The main questions it aims to answer are:
How many adverse events do participants receiving two different doses of siplizumab have compared to rabbit anti-thymocyte globulin (rATG)?
How many participants successfully keep their kidney transplant after receiving siplizumab or rATG? This will be calculated as those participants that did not: die; have their kidney fail to work properly (graft loss); their body rejects their transplant (tissue sample (biopsy)-proven acute rejection: BPAR); or who were lost to follow-up.
How does the body respond to siplizumab after dosing at each of the 2 dose levels?
How does siplizumab work in the body compared to rATG?
Selected participants will be divided into 3 groups. In 2 of the groups, participants will be given siplizumab at one of the two study medicine doses. Participants in the third group will be given rATG. All participants will take the usual anti-rejection medicines given before, during, and after a kidney transplant. All participants will also be given medicines before the study drug to lower the risk of reactions, and medicines used to prevent or treat infections after the transplant.
Participants will be asked to provide their medical history at the first visit at the study site where you will have your kidney transplant. At the first visit and other visits participants will be asked to provide their medication history, have a physical exam, check vital signs, have blood drawn for tests, and have non-invasive tests that record the electrical activity of your heart (ECG) and blood draws.
Participants will be monitored for 12 months after transplant surgery.
Eligibility
Primary outcome measure(s)
- Assessment of the safety of 2 dose levels of siplizumab versus rATG. — 12 months
Number and percentage of participants at 12 months post-transplant experiencing adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs).
Trial sites (14)
| Facility | City | Region | Status |
|---|---|---|---|
| UC Davis Medical Center | Sacramento | California | Not Yet Recruiting |
| Tampa General Hospital | Tampa | Florida | Recruiting |
| Emory University Hospital | Atlanta | Georgia | Recruiting |
| UMass Chan Medical Center | Worcester | Massachusetts | Recruiting |
| University of Michigan - Michigan Medicine | Ann Arbor | Michigan | Recruiting |
| Henry Ford Health | Detroit | Michigan | Recruiting |
| Cooperman Barnabus Medical Center | Livingston | New Jersey | Recruiting |
| University of Texas Southwestern Medical Center | Dallas | Texas | Recruiting |
| Inova Fairfax Hospital | Falls Church | Virginia | Recruiting |
| Virginia Commonwealth University Health | Richmond | Virginia | Recruiting |
| University of Washington Medical Center | Seattle | Washington | Recruiting |
| Fundação Faculdade Regional de Medicina de São José do Rio Preto - Centro Integrado de Pesquisa | São José do Rio Preto | Brazil | Recruiting |
| Hospital Universitari Vall D'Hebron | Barcelona | Spain | Recruiting |
| Hospital Universitario Regional de Malaga | Málaga | Spain | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07508787 on ClinicalTrials.gov ↗ ← All trials in Spain