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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05632523

Acronym

EPIMAC-BELA

Enrollment

Registered

2022-11-30

Start date

2023-12-13

Completion date

2024-11-06

Last updated

2025-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conversion, Renal Transplant

Keywords

Blood sample, Urinary sample

Brief summary

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

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.

Interventions

OTHERBlood sample

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

OTHERurinary sample

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Lymphocyte subpopulations in blood before freezing	Day 0	Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in blood after freezing	Day 0	Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in urine before freezing.	Day 0	Variability in absolute counts and relative proportions immunological analyses in flow cytometry
Lymphocyte subpopulations in urine after freezing.	Day 0	Variability in absolute counts and relative proportions immunological analyses in flow cytometry

Secondary

Measure	Time frame	Description
residual concentrations of belatacept	Day 0	pharmacological analyses by mass spectrometry

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026