RECRUITING Phase 2 ClinicalTrials.gov

A Study Comparing Siplizumab With Rabbit Anti-Thymocyte Globulin to Help the Body Accept a Kidney Transplant

Sponsor: Nefro Avillion Clinical Development, LLC • ClinicalTrials.gov ID: NCT07508787

Registry updated: 2026-10-06

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Description

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.

Interventions

Siplizumab (Drug)
A non-agonistic, humanized, anti-CD2 monoclonal antibody of the IgG1κ class
Rabbit anti-thymocyte globulin (Drug)
An anti-human thymocyte immunoglobulin preparation made of purified polyclonal antibodies derived from rabbits

Eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * Transplant recipients seronegative for EBV. * Transplant recipients receiving a kidney from a non-heart beating donor (ie, DCD) whose organ is retrieved from an uncontrolled DCD or whose donor age \> 55 years of age. * Multi-organ transplant recipients (eg, kidney-pancreas, organ other than kidney), dual-kidney transplant recipients, recipients with more than one prior kidney transplant, or hematopoietic stem cell transplantation recipients. * Presence of current or historical DSA via single-antigen bead assay or local SoC. The MFI cut-off value used to determine the presence of DSA will be defined as per the institutional SoC. Results within 3 months prior to transplant are acceptable. * Crossmatch positive (isolated positive B cell crossmatches are not an exclusion criterion). * ABO-incompatible recipient. * Administration of complement inhibitor therapy within 6 months prior to the transplant, or likely to require treatment with complement inhibitor therapy during the study. * Participants receiving immunosuppressive therapies prior to transplant for pre-existing conditions must be candidates for the protocol-defined regimen. * History of malignancy of any organ system, except for localized excised non-melanomatous skin lesions or carcinoma in situ of the cervix. * Seropositive for human immunodeficiency virus or hepatitis B surface antigen. Participants who are seropositive for hepatitis C virus (HCV) are excluded without proof of sustained viral response after anti-HCV treatment. * Recipient of a kidney from a donor who tests positive for human immunodeficiency virus or hepatitis B surface antigen/hepatitis B core protein. * History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes (eg, siplizumab, rATG, TAC, MPA derivatives, CS). * Evidence of active tuberculosis (TB) infection (participants with a history of latent TB may become eligible after treatment with anti-TB therapy according to national guidelines). * Participants with severe systemic infection(s), at the time of screening or within 2 weeks prior to randomization

Conditions

Renal Transplant Failure and Rejection

Locations

UC Davis Medical Center — Sacramento, California, United States
Tampa General Hospital — Tampa, Florida, United States
Emory University Hospital — Atlanta, Georgia, United States
UMass Chan Medical Center — Worcester, Massachusetts, United States
University of Michigan - Michigan Medicine — Ann Arbor, Michigan, United States
Henry Ford Health — Detroit, Michigan, United States
Cooperman Barnabus Medical Center — Livingston, New Jersey, United States
University of Texas Southwestern Medical Center — Dallas, Texas, United States
Inova Fairfax Hospital — Falls Church, Virginia, United States
Virginia Commonwealth University Health — Richmond, Virginia, United States
University of Washington Medical Center — Seattle, Washington, United States
Fundação Faculdade Regional de Medicina de São José do Rio Preto - Centro Integrado de Pesquisa — São José do Rio Preto, Brazil
Hospital Universitari Vall D'Hebron — Barcelona, Spain
Hospital Universitario Regional de Malaga — Málaga, Spain

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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