Recruiting
Phase 2

Siplizumab & rATG

Sponsor:

Nefro Avillion Clinical Development, LLC

Code:

NCT07508787

Conditions

Renal Transplant Failure and Rejection

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Siplizumab

Rabbit anti-thymocyte globulin

Study Details

Brief 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.

Conditions

Renal Transplant Failure and Rejection

Study ID

NCT07508787

Start date

Jun 29, 2026

Status verified date

Aug, 2026

Completion date

Mar 28, 2028

Anticipated

Primary completion date

Mar 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Low dose siplizumab

experimental: High dose siplizumab

active comparator: Rabbit anti-thymocyte globulin

Interventions

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

Primary outcome measure

  • Assessment of the safety of 2 dose levels of siplizumab versus rATG. [ Time Frame: 12 months ]

Central Contacts and Locations

Locations

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

Contacts

Jennifer Schmidt, BSN, RN

813-844-7041jenniferanilsen@tgh.org

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Emily Temponi, Study Coordinator

404-712-1114emily.k.temponi@emory.edu

University of Michigan - Michigan Medicine

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Nerissa Reister, Clinical Research Coordinator

734-763-5718naflow@med.umich.edu

Cooperman Barnabus Medical Center

Recruiting

Livingston, New Jersey, United States, 07039

Contacts

Jayrol Mock, APN

973-322-2339Jayrol.Mock2@rwjbh.org

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

David Wojciechowski, DO

214-645-7846David.Wojciechowski@UTSouthwestern.edu

University of Washington Medical Center

Recruiting

Seattle, Washington, United States, 98195

Contacts

Belinda Pan, Research Coordinator

206-598-1562bcpan@uw.edu

More Information

Sponsor

Nefro Avillion Clinical Development, LLC

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nefro Avillion Clinical Development, LLC on 2026-09-02.