Siltuximab for Antibody-Mediated Rejection After Lung Transplant
This study is testing a new approach for people who have antibody-mediated rejection (AMR) after a lung transplant. AMR is a serious condition where your body's immune system attacks the transplanted lung. We are looking at the safety of adding a medication called Siltuximab to your usual treatment for AMR. Siltuximab works by blocking a protein called Interleukin-6 (IL-6), which plays a role in inflammation and immune responses. This study will enroll 30 participants who are 18 years or older and have a new diagnosis of AMR. The main goal is to see how safe Siltuximab is by tracking any serious side effects for 90 days. If this study shows Siltuximab is safe, future studies will be needed to see how well it works.
- Study design
- This is an interventional study with a planned enrollment of 30 participants. It is testing Siltuximab against a placebo (an inactive substance).
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track serious side effects for 90 days after randomization.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Phase 1 Clinical Trial of Siltuximab for the Treatment of Antibody-Mediated Rejection After Lung Transplantation
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- Ramsey Hachem, MD · PRINCIPAL_INVESTIGATOR · University of Utah
- Derek Byers, MD, PhD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine
Who to contact
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What this trial measures
- Incidence of CTCAE ≥ grade 3From Randomization to Day 90.
The primary objective is to assess the safety and tolerability of Siltuximab added to routine immunosuppressive treatment for AMR after lung transplantation. The dose of siltuximab (11mg/kg or 5.5 mg/kg) with the least side effect profile will be use for future trials of siltuximab in antibody mediated rejection in lung transplantation.