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Completed

NCT Number: NCT05632523

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

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

Completed

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Key information

Conditions

Renal Transplant Conversion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University hospital

Tours, 37000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sample

Other

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

urinary sample

Other

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

Primary outcomes

  1. Lymphocyte subpopulations in blood before freezing

    Time frame: Day 0

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  2. Lymphocyte subpopulations in blood before freezing

    Time frame: Day 14

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  3. Lymphocyte subpopulations in blood before freezing

    Time frame: Day 28

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  4. Lymphocyte subpopulations in blood before freezing

    Time frame: Day 42

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  5. Lymphocyte subpopulations in blood before freezing

    Time frame: Month 2

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  6. Lymphocyte subpopulations in blood before freezing

    Time frame: Month 3

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  7. Lymphocyte subpopulations in blood before freezing

    Time frame: Month 4

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  8. Lymphocyte subpopulations in blood before freezing

    Time frame: Month 5

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  9. Lymphocyte subpopulations in blood before freezing

    Time frame: Month 6

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  10. Lymphocyte subpopulations in blood after freezing

    Time frame: Day 0

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  11. Lymphocyte subpopulations in blood after freezing

    Time frame: Day 14

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  12. Lymphocyte subpopulations in blood after freezing

    Time frame: Day 28

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  13. Lymphocyte subpopulations in blood after freezing

    Time frame: Day 42

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  14. Lymphocyte subpopulations in blood after freezing

    Time frame: Month 2

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  15. Lymphocyte subpopulations in blood after freezing

    Time frame: Month 3

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  16. Lymphocyte subpopulations in blood after freezing

    Time frame: Month 4

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  17. Lymphocyte subpopulations in blood after freezing

    Time frame: Month 5

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  18. Lymphocyte subpopulations in blood after freezing

    Time frame: Month 6

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  19. Lymphocyte subpopulations in urine before freezing.

    Time frame: Day 0

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  20. Lymphocyte subpopulations in urine before freezing.

    Time frame: Day 14

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  21. Lymphocyte subpopulations in urine before freezing.

    Time frame: Day 28

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  22. Lymphocyte subpopulations in urine before freezing.

    Time frame: Day 42

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  23. Lymphocyte subpopulations in urine before freezing.

    Time frame: Month 2

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  24. Lymphocyte subpopulations in urine before freezing.

    Time frame: Month 3

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  25. Lymphocyte subpopulations in urine before freezing.

    Time frame: Month 4

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  26. Lymphocyte subpopulations in urine before freezing.

    Time frame: Month 5

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  27. Lymphocyte subpopulations in urine before freezing.

    Time frame: Month 6

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  28. Lymphocyte subpopulations in urine after freezing.

    Time frame: Day 0

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  29. Lymphocyte subpopulations in urine after freezing.

    Time frame: Day 14

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  30. Lymphocyte subpopulations in urine after freezing.

    Time frame: Day 28

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  31. Lymphocyte subpopulations in urine after freezing.

    Time frame: Day 42

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  32. Lymphocyte subpopulations in urine after freezing.

    Time frame: Month 2

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  33. Lymphocyte subpopulations in urine after freezing.

    Time frame: Month 3

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  34. Lymphocyte subpopulations in urine after freezing.

    Time frame: Month 4

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  35. Lymphocyte subpopulations in urine after freezing.

    Time frame: Month 5

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

  36. Lymphocyte subpopulations in urine after freezing.

    Time frame: Month 6

    Variability in absolute counts and relative proportions immunological analyses in flow cytometry

Secondary outcomes

  1. residual concentrations of belatacept

    Time frame: Day 0

    pharmacological analyses by mass spectrometry

  2. residual concentrations of belatacept

    Time frame: Day 14

    pharmacological analyses by mass spectrometry

  3. residual concentrations of belatacept

    Time frame: Day 28

    pharmacological analyses by mass spectrometry

  4. residual concentrations of belatacept

    Time frame: Day 42

    pharmacological analyses by mass spectrometry

  5. residual concentrations of belatacept

    Time frame: Month 2

    pharmacological analyses by mass spectrometry

  6. residual concentrations of belatacept

    Time frame: Month 3

    pharmacological analyses by mass spectrometry

  7. residual concentrations of belatacept

    Time frame: Month 4

    pharmacological analyses by mass spectrometry

  8. residual concentrations of belatacept

    Time frame: Month 5

    pharmacological analyses by mass spectrometry

  9. residual concentrations of belatacept

    Time frame: Month 6

    pharmacological analyses by mass spectrometry

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

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

Acronym: EPIMAC-BELA

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 30, 2022
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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