Reduced-dose Alemtuzumab for Kidney Transplant Rejection

Kidney Transplant Rejection Clinical Trial

— ROSETTE  

Official title:

The Effects of Reduced Dose Alemtuzumab for Severe Kidney Transplant Rejection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06100965
• Other study ID #: NL82152.078.23
• Status: Recruiting
• Start date: December 1, 2023
• Est. completion date: July 1, 2026

Study information

• Verified date: February 2024
• Source: Erasmus Medical Center
• Contact: Lukas K van Vugt, Drs.
• Phone: 0031 10 704 0704
• Email: l.k.vanvugt[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplant Rejection

Locations

Country	Name	City	State
Netherlands	Erasmus MC	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion 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.	6 months and 1 year
Secondary	Cumulative incidence of graft loss	Cumulative incidence of graft loss at specified time-points with death as competing risk, computed by cumulative incidence functions.	6 months, 1 year
Secondary	Serious infections	Necessitating hospital admission, or hospital-acquired	6 months, 1 year
Secondary	Patient survival	Proportion of patients who survived at specified time-points, computed with kaplan-meier estimates at specified time-points.	6 months, 1 year