Kidney Transplant Clinical Trials

Clinical trials related to Kidney Transplant Procedure

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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Recipients of a renal allograft from a non-HLA identical living or deceased donor.

• Recipients of a kidney with a cold ischemia time \< 30 hours; hypothermic machine perfusion within the same timeframe is acceptable.

• Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, must agree to use highly effective methods of contraception.

Locations
United States
California
UC Davis Medical Center
NOT_YET_RECRUITING
Sacramento
Florida
Tampa General Hospital
RECRUITING
Tampa
Georgia
Emory University Hospital
RECRUITING
Atlanta
Michigan
University of Michigan - Michigan Medicine
RECRUITING
Ann Arbor
New Jersey
Cooperman Barnabus Medical Center
RECRUITING
Livingston
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Washington
University of Washington Medical Center
RECRUITING
Seattle
Time Frame
Start Date: 2026-06-29
Estimated Completion Date: 2028-03-28
Participants
Target number of participants: 120
Treatments
Experimental: Low dose siplizumab
Experimental: High dose siplizumab
Active_comparator: Rabbit anti-thymocyte globulin
Sponsors
Leads: Nefro Avillion Clinical Development, LLC

This content was sourced from clinicaltrials.gov