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

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: Completed
• Conditions: Renal Transplant; Conversion
• Intervention / Treatment: Other: Blood sample; Other: urinary sample

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: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• France
  • Tours, France, 37000
    • University Hospital

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Lymphocyte subpopulations in blood before freezing	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Day 0
Lymphocyte subpopulations in blood before freezing	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Day 14
Lymphocyte subpopulations in blood before freezing	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Day 28
Lymphocyte subpopulations in blood before freezing	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Day 42
Lymphocyte subpopulations in blood before freezing	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Month 2
Lymphocyte subpopulations in blood before freezing	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Month 3
Lymphocyte subpopulations in blood before freezing	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Month 4
Lymphocyte subpopulations in blood before freezing	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Month 5
Lymphocyte subpopulations in blood before freezing	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Month 6
Lymphocyte subpopulations in blood after freezing	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Day 0
Lymphocyte subpopulations in blood after freezing	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Day 14
Lymphocyte subpopulations in blood after freezing	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Day 28
Lymphocyte subpopulations in blood after freezing	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Day 42
Lymphocyte subpopulations in blood after freezing	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Month 2
Lymphocyte subpopulations in blood after freezing	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Month 3
Lymphocyte subpopulations in blood after freezing	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Month 4
Lymphocyte subpopulations in blood after freezing	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Month 5
Lymphocyte subpopulations in blood after freezing	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Month 6
Lymphocyte subpopulations in urine before freezing.	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Day 0
Lymphocyte subpopulations in urine before freezing.	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Day 14
Lymphocyte subpopulations in urine before freezing.	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Day 28
Lymphocyte subpopulations in urine before freezing.	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Day 42
Lymphocyte subpopulations in urine before freezing.	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Month 2
Lymphocyte subpopulations in urine before freezing.	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Month 3
Lymphocyte subpopulations in urine before freezing.	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Month 4
Lymphocyte subpopulations in urine before freezing.	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Month 5
Lymphocyte subpopulations in urine before freezing.	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Month 6
Lymphocyte subpopulations in urine after freezing.	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Day 0
Lymphocyte subpopulations in urine after freezing.	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Day 14
Lymphocyte subpopulations in urine after freezing.	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Day 28
Lymphocyte subpopulations in urine after freezing.	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Day 42
Lymphocyte subpopulations in urine after freezing.	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Month 2
Lymphocyte subpopulations in urine after freezing.	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Month 3
Lymphocyte subpopulations in urine after freezing.	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Month 4
Lymphocyte subpopulations in urine after freezing.	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Month 5
Lymphocyte subpopulations in urine after freezing.	Variability in absolute counts and relative proportions immunological analyses in flow cytometry	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
residual concentrations of belatacept	pharmacological analyses by mass spectrometry	Day 0
residual concentrations of belatacept	pharmacological analyses by mass spectrometry	Day 14
residual concentrations of belatacept	pharmacological analyses by mass spectrometry	Day 28
residual concentrations of belatacept	pharmacological analyses by mass spectrometry	Day 42
residual concentrations of belatacept	pharmacological analyses by mass spectrometry	Month 2
residual concentrations of belatacept	pharmacological analyses by mass spectrometry	Month 3
residual concentrations of belatacept	pharmacological analyses by mass spectrometry	Month 4
residual concentrations of belatacept	pharmacological analyses by mass spectrometry	Month 5
residual concentrations of belatacept	pharmacological analyses by mass spectrometry	Month 6

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Principal Investigator: Philippe GATAULT, University Hospital, Tours

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2023
• Primary Completion (Actual): November 6, 2024
• Study Completion (Actual): November 6, 2024

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 18, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 5, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Blood sample; Urinary sample
• Other Study ID 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