NCT05632523

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 30, 2022

Completed
1 year until next milestone

Study Start

First participant enrolled

December 13, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2024

Completed
Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

11 months

First QC Date

November 7, 2022

Last Update Submit

August 5, 2025

Conditions

Renal TransplantConversion

Keywords

Blood sampleUrinary sample

Outcome Measures

Primary Outcomes (36)

  • 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 Outcomes (9)

  • residual concentrations of belatacept

    Day 0

  • residual concentrations of belatacept

    Day 14

  • residual concentrations of belatacept

    Day 28

  • residual concentrations of belatacept

    Day 42

  • residual concentrations of belatacept

    Month 2

  • +4 more secondary outcomes

Study Arms (1)

adult patients with renal transplant

Conversion from anticalcineurin to belatacept

Other: Blood sampleOther: urinary sample

Interventions

Blood sampleOTHER

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

adult patients with renal transplant
urinary sampleOTHER

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

adult patients with renal transplant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Age ≥ 18 years
  • Renal transplant patient
  • Patient converted from an anticalcineurin to belatacept

You may not qualify if:

  • Opposition to data processing
  • Hemoglobin \< 9g/dL
  • Patient under judicial protection
  • Pregnant or breastfeeding woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital

Tours, 37000, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urinary

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Philippe GATAULT

    University Hospital, Tours

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2022

First Posted

November 30, 2022

Study Start

December 13, 2023

Primary Completion

November 6, 2024

Study Completion

November 6, 2024

Last Updated

August 11, 2025

Record last verified: 2025-08

Locations

FR(1)