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NCT05632523 Clinical Trial

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

Renal Transplant Clinical Trial

— EPIMAC-BELA  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05632523
Other study ID # DR210053
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 2023
Est. completion date March 2024

Study information
Verified date October 2023
Source University Hospital, Tours
Contact Philippe GATAULT
Phone 02 47 47 37 46
Email philippe.gatault@univ-tours.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 15
Est. completion date March 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Blood sample
Blood samples are taken at each visit to the day hospital for a programmed belatacept perfusion
• urinary sample
Urinary samples are taken at each visit to the day hospital for a programmed belatacept perfusion

Locations
Country Name City State
France University hospital Tours

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Lymphocyte subpopulations in blood before freezing Variability in absolute counts and relative proportions immunological analyses in flow cytometry Day 0
Primary Lymphocyte subpopulations in blood before freezing Variability in absolute counts and relative proportions immunological analyses in flow cytometry Day 14
Primary Lymphocyte subpopulations in blood before freezing Variability in absolute counts and relative proportions immunological analyses in flow cytometry Day 28
Primary Lymphocyte subpopulations in blood before freezing Variability in absolute counts and relative proportions immunological analyses in flow cytometry Day 42
Primary Lymphocyte subpopulations in blood before freezing Variability in absolute counts and relative proportions immunological analyses in flow cytometry Month 2
Primary Lymphocyte subpopulations in blood before freezing Variability in absolute counts and relative proportions immunological analyses in flow cytometry Month 3
Primary Lymphocyte subpopulations in blood before freezing Variability in absolute counts and relative proportions immunological analyses in flow cytometry Month 4
Primary Lymphocyte subpopulations in blood before freezing Variability in absolute counts and relative proportions immunological analyses in flow cytometry Month 5
Primary Lymphocyte subpopulations in blood before freezing Variability in absolute counts and relative proportions immunological analyses in flow cytometry Month 6
Primary Lymphocyte subpopulations in blood after freezing Variability in absolute counts and relative proportions immunological analyses in flow cytometry Day 0
Primary Lymphocyte subpopulations in blood after freezing Variability in absolute counts and relative proportions immunological analyses in flow cytometry Day 14
Primary Lymphocyte subpopulations in blood after freezing Variability in absolute counts and relative proportions immunological analyses in flow cytometry Day 28
Primary Lymphocyte subpopulations in blood after freezing Variability in absolute counts and relative proportions immunological analyses in flow cytometry Day 42
Primary Lymphocyte subpopulations in blood after freezing Variability in absolute counts and relative proportions immunological analyses in flow cytometry Month 2
Primary Lymphocyte subpopulations in blood after freezing Variability in absolute counts and relative proportions immunological analyses in flow cytometry Month 3
Primary Lymphocyte subpopulations in blood after freezing Variability in absolute counts and relative proportions immunological analyses in flow cytometry Month 4
Primary Lymphocyte subpopulations in blood after freezing Variability in absolute counts and relative proportions immunological analyses in flow cytometry Month 5
Primary Lymphocyte subpopulations in blood after freezing Variability in absolute counts and relative proportions immunological analyses in flow cytometry Month 6
Primary Lymphocyte subpopulations in urine before freezing. Variability in absolute counts and relative proportions immunological analyses in flow cytometry Day 0
Primary Lymphocyte subpopulations in urine before freezing. Variability in absolute counts and relative proportions immunological analyses in flow cytometry Day 14
Primary Lymphocyte subpopulations in urine before freezing. Variability in absolute counts and relative proportions immunological analyses in flow cytometry Day 28
Primary Lymphocyte subpopulations in urine before freezing. Variability in absolute counts and relative proportions immunological analyses in flow cytometry Day 42
Primary Lymphocyte subpopulations in urine before freezing. Variability in absolute counts and relative proportions immunological analyses in flow cytometry Month 2
Primary Lymphocyte subpopulations in urine before freezing. Variability in absolute counts and relative proportions immunological analyses in flow cytometry Month 3
Primary Lymphocyte subpopulations in urine before freezing. Variability in absolute counts and relative proportions immunological analyses in flow cytometry Month 4
Primary Lymphocyte subpopulations in urine before freezing. Variability in absolute counts and relative proportions immunological analyses in flow cytometry Month 5
Primary Lymphocyte subpopulations in urine before freezing. Variability in absolute counts and relative proportions immunological analyses in flow cytometry Month 6
Primary Lymphocyte subpopulations in urine after freezing. Variability in absolute counts and relative proportions immunological analyses in flow cytometry Day 0
Primary Lymphocyte subpopulations in urine after freezing. Variability in absolute counts and relative proportions immunological analyses in flow cytometry Day 14
Primary Lymphocyte subpopulations in urine after freezing. Variability in absolute counts and relative proportions immunological analyses in flow cytometry Day 28
Primary Lymphocyte subpopulations in urine after freezing. Variability in absolute counts and relative proportions immunological analyses in flow cytometry Day 42
Primary Lymphocyte subpopulations in urine after freezing. Variability in absolute counts and relative proportions immunological analyses in flow cytometry Month 2
Primary Lymphocyte subpopulations in urine after freezing. Variability in absolute counts and relative proportions immunological analyses in flow cytometry Month 3
Primary Lymphocyte subpopulations in urine after freezing. Variability in absolute counts and relative proportions immunological analyses in flow cytometry Month 4
Primary Lymphocyte subpopulations in urine after freezing. Variability in absolute counts and relative proportions immunological analyses in flow cytometry Month 5
Primary Lymphocyte subpopulations in urine after freezing. Variability in absolute counts and relative proportions immunological analyses in flow cytometry Month 6
Secondary residual concentrations of belatacept pharmacological analyses by mass spectrometry Day 0
Secondary residual concentrations of belatacept pharmacological analyses by mass spectrometry Day 14
Secondary residual concentrations of belatacept pharmacological analyses by mass spectrometry Day 28
Secondary residual concentrations of belatacept pharmacological analyses by mass spectrometry Day 42
Secondary residual concentrations of belatacept pharmacological analyses by mass spectrometry Month 2
Secondary residual concentrations of belatacept pharmacological analyses by mass spectrometry Month 3
Secondary residual concentrations of belatacept pharmacological analyses by mass spectrometry Month 4
Secondary residual concentrations of belatacept pharmacological analyses by mass spectrometry Month 5
Secondary residual concentrations of belatacept pharmacological analyses by mass spectrometry Month 6
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