Kidney Transplant Rejection
Conditions
Keywords
alemtuzumab
Brief summary
Prospective, follow-up study of kidney transplant recipients treated with alemtuzumab anti-rejection therapy for severe or glucocorticoid-resistant kidney transplant rejection.
Detailed description
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.
Interventions
None listed
Sponsors
Erasmus Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with lymphocyte repopulation | 6 months and 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of graft loss | 6 months, 1 year | Cumulative incidence of graft loss at specified time-points with death as competing risk, computed by cumulative incidence functions. |
| Serious infections | 6 months, 1 year | Necessitating hospital admission, or hospital-acquired |
| Patient survival | 6 months, 1 year | Proportion of patients who survived at specified time-points, computed with kaplan-meier estimates at specified time-points. |
Countries
Netherlands
Contacts
Primary ContactLukas K van Vugt, Drs.
Outcome results
None listed