AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingPhase 2Ages 18 Years - 70 YearsAllNefro Avillion Clinical Development, LLC
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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, parti

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
๐Ÿ’Š

What it tests

  • Siplizumab
  • Rabbit anti-thymocyte globulin
๐Ÿ“

Where

14 sites
UC Davis Medical Center
Sacramento, United States
Tampa General Hospital
Tampa, United States
Emory University Hospital
Atlanta, United States
UMass Chan Medical Center
Worcester, United States
University of Michigan - Michigan Medicine
Ann Arbor, United States
Henry Ford Health
Detroit, United States
Cooperman Barnabus Medical Center
Livingston, United States
University of Texas Southwestern Medical Center
Dallas, United States

โ€ฆand 6 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy