NCT06100965

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
1mo left

Started Dec 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Dec 2023Jul 2026

First Submitted

Initial submission to the registry

October 20, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

February 21, 2024

Status Verified

February 1, 2024

Enrollment Period

1.6 years

First QC Date

October 20, 2023

Last Update Submit

February 20, 2024

Conditions

Kidney Transplant Rejection

Keywords

alemtuzumab

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Cumulative incidence of graft loss

    6 months, 1 year

  • Serious infections

    6 months, 1 year

  • Patient survival

    6 months, 1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Kidney transplant recipients who experience severe or glucocorticoid-resistant rejection of their allograft.

You may qualify if:

  • years or older
  • Treatment for severe or glucocorticoid-resistant kidney transplant rejection with alemtuzumab.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urinary samples Whole-blood and serum samples

Central Study Contacts

Lukas K van Vugt, Drs.

CONTACT

0031 10 704 0704l.k.vanvugt@erasmusmc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research coordinator

Study Record Dates

First Submitted

October 20, 2023

First Posted

October 25, 2023

Study Start

December 1, 2023

Primary Completion

July 1, 2025

Study Completion (Estimated)

July 1, 2026

Last Updated

February 21, 2024

Record last verified: 2024-02

Locations

NL(1)