Prospective, follow-up study of kidney transplant recipients treated with alemtuzumab anti-rejection therapy for severe or glucocorticoid-resistant kidney transplant rejection.
Study design: Prospective observational cohort study. Study population: Adult patients who are treated with alemtuzumab for severe or glucocorticoid-resistant kidney transplant rejection. Intervention (if applicable): Not applicable. Main study parameters/endpoints: 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.
Study Type
OBSERVATIONAL
Enrollment
25
Erasmus MC
Rotterdam, South Holland, Netherlands
RECRUITINGProportion of patients with lymphocyte repopulation
Outcome reporting of the proportion of patients that has repopulation of T and B lymphocytes, defined as cell counts of \>200 10E6/L for T lymphocytes and \> 100 10E6/L for B lymphocytes.
Time frame: 6 months and 1 year
Cumulative incidence of graft loss
Cumulative incidence of graft loss at specified time-points with death as competing risk, computed by cumulative incidence functions.
Time frame: 6 months, 1 year
Serious infections
Necessitating hospital admission, or hospital-acquired
Time frame: 6 months, 1 year
Patient survival
Proportion of patients who survived at specified time-points, computed with kaplan-meier estimates at specified time-points.
Time frame: 6 months, 1 year
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