Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05890430
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-08
First Post:
2023-05-25
Brief Title:
Study of Alloimmune Response in Humoral Rejection After Kidney Transplantation
Sponsor:
University Hospital Strasbourg France
Organization:
University Hospital Strasbourg France
Study Overview
Official Title:
Study of Alloimmune Response in Humoral Rejection After Kidney Transplantation REjet Cellules Immunitaires Transplantation rEnale RECITE
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RECITE
Brief Summary:
We will study a prospective cohort including all kidney transplant recipients undergoing kidney graft biopsy in one kidney transplantation center for a duration of 5 years
Our primary outcome is to compare the number of circulating NK cells between patients and without humoral rejection
Our secondary outcomes are to describe the cellular genetic humoral and histological characteristics of humoral rejection and their evolution
Our primary outcome is to compare the number of circulating NK cells between patients and without humoral rejection
Our secondary outcomes are to describe the cellular genetic humoral and histological characteristics of humoral rejection and their evolution
Detailed Description:
Information and inclusion visit V0 The information and inclusion visit will be carried out on the day of the graft biopsy or in the case of pre-scheduled biopsies during a consultation prior to the biopsy still as part of standard follow-up This is particularly the case for patients undergoing systematic biopsy The indication for graft puncture-biopsy is generally decided by the nephrologist in charge of the patient or at departmental meetings for complex cases
During this consultation the physician verifies the inclusion criteria and obtains the patients consent to take part in the study We explain to the patient the scientific interest of evaluating the immune response in humoral rejection and the absence of repercussions for the patients subsequent management A routine clinical examination is performed and the patients current treatment regimen is notified
If the patient agrees a blood sample is taken for the standard biology follow-up of transplant patients and for the study samples
Serum factors 4 dry tubes or SST or EDTA 5 ml maximum
PBMCs 8 heparinized tubes of 10 ml maximum which may be replaced by Paxgen tubes in case of technical or logistical necessity
Urine 5 dry tubes or SST 5 ml maximum
Patients will be divided into two groups according to the indication for biopsy with an influence on follow-up
patients who underwent systematic biopsy M3 and M12
patients included in a biopsy for cause whatever the distance to the graft
Follow-up visits V1 V2 V3 etc Subsequently new samples may be offered to included patients in order to compare the parameters studied at the time of and after their graft biopsies The different follow-up times are indexed to the standard follow-up of kidney transplant patients
-Patients routinely biopsied between M0 and M6 of transplantation most often M3 Follow-up will be indexed to post-transplant consultation follow-up New samples may be taken at M6 M9 M12 at the time of the second systematic biopsy M18 M24 of transplantation or during a follow-up biopsy
Patients biopsied for cause at any time post-transplant follow-up will be indexed to the completion of patient follow-up consultations New samples may be taken at M3 M6 M9 M12 M18 M24 after the biopsy or during a follow-up biopsy
With the patients consent blood and urine samples are taken for the standard follow-up biology of transplant patients and for the study samples
Serum factors 4 dry tubes or SST or EDTA 5 ml maximum
PBMCs 8 heparinized tubes of 10 ml maximum which may be replaced by Paxgen tubes in case of technical or logistical necessity
Urines 5 dry tubes or SST 5 ml
During this consultation the physician verifies the inclusion criteria and obtains the patients consent to take part in the study We explain to the patient the scientific interest of evaluating the immune response in humoral rejection and the absence of repercussions for the patients subsequent management A routine clinical examination is performed and the patients current treatment regimen is notified
If the patient agrees a blood sample is taken for the standard biology follow-up of transplant patients and for the study samples
Serum factors 4 dry tubes or SST or EDTA 5 ml maximum
PBMCs 8 heparinized tubes of 10 ml maximum which may be replaced by Paxgen tubes in case of technical or logistical necessity
Urine 5 dry tubes or SST 5 ml maximum
Patients will be divided into two groups according to the indication for biopsy with an influence on follow-up
patients who underwent systematic biopsy M3 and M12
patients included in a biopsy for cause whatever the distance to the graft
Follow-up visits V1 V2 V3 etc Subsequently new samples may be offered to included patients in order to compare the parameters studied at the time of and after their graft biopsies The different follow-up times are indexed to the standard follow-up of kidney transplant patients
-Patients routinely biopsied between M0 and M6 of transplantation most often M3 Follow-up will be indexed to post-transplant consultation follow-up New samples may be taken at M6 M9 M12 at the time of the second systematic biopsy M18 M24 of transplantation or during a follow-up biopsy
Patients biopsied for cause at any time post-transplant follow-up will be indexed to the completion of patient follow-up consultations New samples may be taken at M3 M6 M9 M12 M18 M24 after the biopsy or during a follow-up biopsy
With the patients consent blood and urine samples are taken for the standard follow-up biology of transplant patients and for the study samples
Serum factors 4 dry tubes or SST or EDTA 5 ml maximum
PBMCs 8 heparinized tubes of 10 ml maximum which may be replaced by Paxgen tubes in case of technical or logistical necessity
Urines 5 dry tubes or SST 5 ml
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None