transplantaat-afstoting kidney transplant rejection
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - 18 years or older - Treatment for severe or glucocorticoid-resistant kidney transplant rejection with alemtuzumab.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint is T lymphocyte repopulation. This will be reported as the proportion of patients which is repopulated with T cell counts > 200 x 106/L at six months after initiation of therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Lymphocyte (subtype) repopulation, serious infections, one-year graft survival, alemtuzumab plasma levels, intra-cellular signalling of repopulated T and B cells, cytokine-levels, donor-specificity of repopulated T cells, differences pre- and post-treatment of donor-derived cell-free DNA, plasma nucleosomes, urinary chemokines, urinary extracellular vesicles, breath-pattern analysis. | — |
Countries
Netherlands
Outcome results
None listed