Early Pharmacological and Immune Monitoring After Conversion to Belatacept in Renal Transplant Patients

NCT ID: NCT05632523

Last Updated: 2025-08-11

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

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-13

Study Completion Date

2024-11-06

Brief Summary

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Single-center, prospective, translational, clinical-biological, multidisciplinary study

Detailed Description

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All patients starting belatacept will be informed about non-interventional study and will be included unless they do not accept (non-opposition, consent is not required). Patients will be included and followed up during the 6 first months, i.e. 9 infusions. Blood samples (3 heparinized tubes of 7ml + 1 dry tube without separator gel of 5ml, i.e. 26ml maximum per sample) and urine samples will be harvested before each perfusions and in case of rejection. Clinical and biological data will be collected in an electronic CRF.

Conditions

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Renal Transplant Conversion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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adult patients with renal transplant

Conversion from anticalcineurin to belatacept

Blood sample

Intervention Type OTHER

Blood samples are taken at each visit to the day hospital for a programmed belatacept perfusion

urinary sample

Intervention Type OTHER

Urinary samples are taken at each visit to the day hospital for a programmed belatacept perfusion

Interventions

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Blood sample

Blood samples are taken at each visit to the day hospital for a programmed belatacept perfusion

Intervention Type OTHER

urinary sample

Urinary samples are taken at each visit to the day hospital for a programmed belatacept perfusion

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Renal transplant patient
* Patient converted from an anticalcineurin to belatacept

Exclusion Criteria

* Opposition to data processing
* Hemoglobin \< 9g/dL
* Patient under judicial protection
* Pregnant or breastfeeding woman
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe GATAULT

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Tours

Locations

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University hospital

Tours, , France

Site Status

Countries

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France

Other Identifiers

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DR210053

Identifier Type: -

Identifier Source: org_study_id

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