Reduced-dose Alemtuzumab for kidney transplant rejection
The Effects of Reduced Dose Alemtuzumab for Severe Kidney Transplant Rejection
This study is testing whether using lower doses of alemtuzumab can help kidney transplant recipients who are having severe rejection issues feel better and keep their transplant for longer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Drugs / interventions | alemtuzumab |
| Locations | 1 site (Rotterdam, South Holland) |
| Trial ID | NCT06100965 on ClinicalTrials.gov |
What this trial studies
This observational study follows kidney transplant recipients who are treated with reduced doses of alemtuzumab for severe or glucocorticoid-resistant kidney transplant rejection. It aims to assess various parameters such as lymphocyte repopulation, serious infections, and one-year graft survival among participants. The study will also evaluate alemtuzumab plasma levels and the immune response of T and B cells post-treatment. By analyzing these factors, the study seeks to improve understanding of the effectiveness and safety of reduced-dose alemtuzumab in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adult patients aged 18 years or older who are experiencing severe or glucocorticoid-resistant kidney transplant rejection and are being treated with alemtuzumab.
Not a fit: Patients who have received other lymphocyte depleting agents prior to alemtuzumab treatment or have low T cell counts may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of kidney transplant rejection, enhancing graft survival and reducing complications.
How similar studies have performed: While this approach is observational, similar studies using alemtuzumab for kidney transplant rejection have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older * Treatment for severe or glucocorticoid-resistant kidney transplant rejection with alemtuzumab. Exclusion Criteria: * Treatment with a different lymphocyte depleting agent (e.g. rATG) prior to treatment with alemtuzumab for the same rejection episode. * Recipients who have T cell counts below 200 × 106/L before the start of therapy (for instance, because of lymphocyte depleting induction therapies). * Inability to provide written informed consent
Where this trial is running
Rotterdam, South Holland
- Erasmus MC — Rotterdam, South Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Lukas K van Vugt, Drs.
- Email: l.k.vanvugt@erasmusmc.nl
- Phone: 0031 10 704 0704
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.