Actively Recruiting
The Effects of Reduced Dose Alemtuzumab for Severe Kidney Transplant Rejection
Led by Erasmus Medical Center · Updated on 2024-02-21
25
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to follow adult kidney transplant recipients who receive alemtuzumab treatment for severe or glucocorticoid-resistant transplant rejection. The study is observational and focuses on patients treated specifically with alemtuzumab to better understand immune cell recovery and related health outcomes after this treatment. Participants are observed without intervention from the study team. Researchers will monitor lymphocyte subtype repopulation, plasma levels of alemtuzumab, immune cell signaling, cytokine levels, and donor-specific T cell responses. They will also assess various biomarkers such as donor-derived cell-free DNA, plasma nucleosomes, urinary chemokines, extracellular vesicles, and breath patterns to gather comprehensive data on immune response and transplant status. Throughout the study, patients will be followed for up to one year to evaluate important outcomes including lymphocyte recovery, graft survival, serious infections, and patient survival. Data collection involves regular blood tests and other assessments to track immune system changes and transplant health. This approach helps researchers understand the effects of alemtuzumab on transplant rejection and patient health over time.
CONDITIONS
Brief Title
Reduced-dose Alemtuzumab for Kidney Transplant Rejection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Treated with alemtuzumab for severe or glucocorticoid-resistant kidney transplant rejection
You will not qualify if you...
- Prior treatment with a different lymphocyte depleting agent (e.g., rATG) for the same rejection episode
- T cell counts below 200 �d7 10�sup� 6�/L before starting therapy
- Unable to provide written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 year
Participants who have been treated with alemtuzumab for severe kidney transplant rejection are observed to assess lymphocyte repopulation, infections, graft survival, and other biological markers.
Trial Site Locations
Total: 1 location
1
Erasmus MC
Rotterdam, South Holland, Netherlands, 3015 GD
Actively Recruiting
Research Team
L
Lukas K van Vugt, Drs.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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