ROSETTE: Reduced-dose Alemtuzumab for Kidney Transplant Rejection

Sponsor

Erasmus Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06100965

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Anticipated Enrollment :

25 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The Effects of Reduced Dose Alemtuzumab for Severe Kidney Transplant Rejection

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2026

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Erasmus Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lukas K. van Vugt, Research coordinator, Erasmus Medical Center

ClinicalTrials.gov Identifier:

NCT06100965

Other Study ID Numbers:

NL82152.078.23

First Posted:

Oct 25, 2023

Last Update Posted:

Oct 26, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Lukas K. van Vugt, Research coordinator, Erasmus Medical Center

alemtuzumab

Study Results

No Results Posted as of Oct 26, 2023