Reduced-dose Alemtuzumab for Kidney Transplant Rejection (ROSETTE)

Erasmus University

Status: Enrolling

Conditions: Kidney Transplant Rejection

Study type: Observational

Funder types: Other

Identifiers

NCT06100965

NL82152.078.23

Details and patient eligibility

About

Prospective, follow-up study of kidney transplant recipients treated with alemtuzumab anti-rejection therapy for severe or glucocorticoid-resistant kidney transplant rejection.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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