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

Conditions

• Renal Transplant Failure and Rejection

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

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

Study Details

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.

Key Dates

Start date

Jun 29, 2026

Status verified

Jun 2026

Primary completion

Mar 28, 2028

Completion

Mar 28, 2028

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Low dose siplizumab
• Experimental: High dose siplizumab
• Active Comparator: Rabbit anti-thymocyte globulin

Primary Outcome Measure

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

Locations (2)

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