Early Pharmacological and Immune Monitoring After Conversion to Belatacept in Renal Transplant Patients (EPIMAC-BELA)

August 5, 2025 updated by: University Hospital, Tours

Surveillance Pharmacologique et Immunitaire précoce après Conversion au Belatacept Chez Les Patients Ayant Subi Une Transplantation rénale : étude Pilote

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Tours, France, 37000
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with renal transplant, converted from an anticalcineurin to belatacept at the Tours CHRU.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
adult patients with renal transplant
Conversion from anticalcineurin to belatacept
Other: Blood sample
Blood samples are taken at each visit to the day hospital for a programmed belatacept perfusion
Other: urinary sample
Urinary samples are taken at each visit to the day hospital for a programmed belatacept perfusion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Lymphocyte subpopulations in blood before freezing
Time Frame: Day 0
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Day 0
Lymphocyte subpopulations in blood before freezing
Time Frame: Day 14
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Day 14
Lymphocyte subpopulations in blood before freezing
Time Frame: Day 28
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Day 28
Lymphocyte subpopulations in blood before freezing
Time Frame: Day 42
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Day 42
Lymphocyte subpopulations in blood before freezing
Time Frame: Month 2
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Month 2
Lymphocyte subpopulations in blood before freezing
Time Frame: Month 3
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Month 3
Lymphocyte subpopulations in blood before freezing
Time Frame: Month 4
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Month 4
Lymphocyte subpopulations in blood before freezing
Time Frame: Month 5
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Month 5
Lymphocyte subpopulations in blood before freezing
Time Frame: Month 6
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Month 6
Lymphocyte subpopulations in blood after freezing
Time Frame: Day 0
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Day 0
Lymphocyte subpopulations in blood after freezing
Time Frame: Day 14
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Day 14
Lymphocyte subpopulations in blood after freezing
Time Frame: Day 28
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Day 28
Lymphocyte subpopulations in blood after freezing
Time Frame: Day 42
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Day 42
Lymphocyte subpopulations in blood after freezing
Time Frame: Month 2
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Month 2
Lymphocyte subpopulations in blood after freezing
Time Frame: Month 3
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Month 3
Lymphocyte subpopulations in blood after freezing
Time Frame: Month 4
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Month 4
Lymphocyte subpopulations in blood after freezing
Time Frame: Month 5
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Month 5
Lymphocyte subpopulations in blood after freezing
Time Frame: Month 6
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Month 6
Lymphocyte subpopulations in urine before freezing.
Time Frame: Day 0
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Day 0
Lymphocyte subpopulations in urine before freezing.
Time Frame: Day 14
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Day 14
Lymphocyte subpopulations in urine before freezing.
Time Frame: Day 28
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Day 28
Lymphocyte subpopulations in urine before freezing.
Time Frame: Day 42
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Day 42
Lymphocyte subpopulations in urine before freezing.
Time Frame: Month 2
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Month 2
Lymphocyte subpopulations in urine before freezing.
Time Frame: Month 3
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Month 3
Lymphocyte subpopulations in urine before freezing.
Time Frame: Month 4
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Month 4
Lymphocyte subpopulations in urine before freezing.
Time Frame: Month 5
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Month 5
Lymphocyte subpopulations in urine before freezing.
Time Frame: Month 6
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Month 6
Lymphocyte subpopulations in urine after freezing.
Time Frame: Day 0
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Day 0
Lymphocyte subpopulations in urine after freezing.
Time Frame: Day 14
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Day 14
Lymphocyte subpopulations in urine after freezing.
Time Frame: Day 28
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Day 28
Lymphocyte subpopulations in urine after freezing.
Time Frame: Day 42
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Day 42
Lymphocyte subpopulations in urine after freezing.
Time Frame: Month 2
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Month 2
Lymphocyte subpopulations in urine after freezing.
Time Frame: Month 3
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Month 3
Lymphocyte subpopulations in urine after freezing.
Time Frame: Month 4
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Month 4
Lymphocyte subpopulations in urine after freezing.
Time Frame: Month 5
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Month 5
Lymphocyte subpopulations in urine after freezing.
Time Frame: Month 6
Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
residual concentrations of belatacept
Time Frame: Day 0
pharmacological analyses by mass spectrometry
Day 0
residual concentrations of belatacept
Time Frame: Day 14
pharmacological analyses by mass spectrometry
Day 14
residual concentrations of belatacept
Time Frame: Day 28
pharmacological analyses by mass spectrometry
Day 28
residual concentrations of belatacept
Time Frame: Day 42
pharmacological analyses by mass spectrometry
Day 42
residual concentrations of belatacept
Time Frame: Month 2
pharmacological analyses by mass spectrometry
Month 2
residual concentrations of belatacept
Time Frame: Month 3
pharmacological analyses by mass spectrometry
Month 3
residual concentrations of belatacept
Time Frame: Month 4
pharmacological analyses by mass spectrometry
Month 4
residual concentrations of belatacept
Time Frame: Month 5
pharmacological analyses by mass spectrometry
Month 5
residual concentrations of belatacept
Time Frame: Month 6
pharmacological analyses by mass spectrometry
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Tours

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Philippe GATAULT, University Hospital, Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 13, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 6, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 6, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 30, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DR210053

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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