Siplizumab vs rATG for kidney transplant induction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 trial randomizes approximately 120 adult renal transplant candidates to three groups: two different doses of siplizumab or rATG as induction therapy, with stratification by donor type. All participants will receive standard background immunosuppression and monitoring for safety and rejection through 12 months. The study assesses safety by recording adverse events and biopsy-proven acute rejection, as well as how each treatment affects immune response and transplant outcomes. Final analysis will determine whether siplizumab at either dose is as safe and effective as rATG for induction therapy. Safety, pharmacodynamics, and immunologic effects will be evaluated throughout the study period.

Why it matters

Who can join: the full rules

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

Where it's running

• Keck Hospital of the University of Southern California
  Los Angeles, California, United States Recruiting
• University of California - Los Angeles, Connie Frank Kidney Transplant Center
  Los Angeles, California, United States Recruiting
• UC Davis Medical Center
  Sacramento, California, United States Recruiting
• Tampa General Hospital
  Tampa, Florida, United States Recruiting
• Emory University Hospital
  Atlanta, Georgia, United States Recruiting
• University of Kansas Hospital
  Kansas City, Kansas, United States Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using Siplizumab to prevent immune issues in liver transplant patients with autoimmune liver disease

  This study is testing if a new medication called siplizumab can help prevent immune problems in adults with autoimmune liver disease who are getting a liver transplant.

  Recruiting Phase 1 Columbia University · New York, New York · NCT06455280

• Evaluating Siplizumab for Hidradenitis Suppurativa Treatment

  This study is testing whether a new medication called siplizumab can help people with moderate to severe Hidradenitis Suppurativa who haven't found relief with other treatments.

  Recruiting Early Phase 1 University of Alabama at Birmingham · Birmingham, Alabama · NCT06326476

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.