Actively Recruiting

Age: 18Years +
All Genders
ID06100965

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older
  • Treated with alemtuzumab for severe or glucocorticoid-resistant kidney transplant rejection
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Monitoring

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

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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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