Reduced-dose Alemtuzumab for Kidney Transplant Rejection

NCT ID: NCT06100965

Last Updated: 2024-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2026-07-01

Brief Summary

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

Detailed Description

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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

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Kidney Transplant Rejection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Lukas K. van Vugt

Research coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Erasmus MC

Rotterdam, South Holland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Lukas K van Vugt, Drs.

Role: CONTACT

0031 10 704 0704

Facility Contacts

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Lukas K van Vugt, Drs.

Role: primary

0031 10 704 0704

Other Identifiers

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NL82152.078.23

Identifier Type: -

Identifier Source: org_study_id

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