NCT06100965

Reduced-dose Alemtuzumab for Kidney Transplant Rejection

The Effects of Reduced Dose Alemtuzumab for Severe Kidney Transplant Rejection

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 25 (estimated)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Transplant Rejection

Timeline

• Start date: 2023-12-01
• Primary completion: 2025-07-01
• Completion: 2026-07-01
• First posted: 2023-10-25
• Last updated: 2024-02-21

Locations

1 site across 1 country: Netherlands