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A Study Comparing Siplizumab to Help Your Body Accept a Kidney Transplant

This study is looking at whether a drug called siplizumab can help prevent your body from rejecting a new kidney. It compares siplizumab to another drug, rabbit anti-thymocyte globulin (rATG), which is already used for this purpose. We want to see how safe siplizumab is at two different doses and how well it helps people keep their kidney transplant working. You might be able to join if you are an adult between 18 and 70 years old who is receiving a kidney transplant. The study aims to enroll about 120 people, but the current status of recruitment is unclear.

Study design
This study will randomly assign participants into one of three groups: two groups will receive different doses of siplizumab, and one group will receive rATG. About 120 people will be enrolled.
What's involved
You will receive study treatment infusions and other medications, then have assessments and procedures through 12 months after your transplant, or until the study ends.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after their transplant to assess safety and kidney function.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07508787

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

Recruiting
PHASE2Ages 18–70InterventionalPrevention
Nefro Avillion Clinical Development, LLC
~120 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:SiplizumabRabbit anti-thymocyte globulin

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assessment of the safety of 2 dose levels of siplizumab versus rATG.
Measured over 12 months

Conditions

Renal Transplant Failure and Rejection

Explore related trials

Acute Allograft NephropathyChronic Kidney Disease, Stage 5Failed renal transplant

Where it's being run

7 sites across 7 states
California1
Florida1
Georgia1
Michigan1
New Jersey1
Texas1
Washington1

Who to contact

Timothy Huynh, Clinical Research Coordinator
[email protected]
916-703-4471
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 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).