Reduced-dose Alemtuzumab for Kidney Transplant Rejection

Recruiting

• Conditions: Kidney Transplant Rejection

• Registration Number: NCT06100965
• Lead Sponsor: Erasmus Medical Center

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.

Study Timeline

• Study First Submitted: 2023-10-20
• Study First Submitted QC: 2023-10-20
• Study First Posted: 2023-10-25
• Study Start: 2023-12-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-21
• Primary Completion: 2025-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Erasmus MC; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands