Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05890430 |
| Other study ID # |
8968 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 2023 |
| Est. completion date |
July 2033 |
Study information
| Verified date |
May 2023 |
| Source |
University Hospital, Strasbourg, France |
| Contact |
Sophie CAILLARD-OHLMANN, PU-PH |
| Phone |
03 69 55 05 11 |
| Email |
sophie.caillard[@]chru-strasbourg.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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
patient's 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 patient's subsequent management. A routine clinical examination is
performed, and the patient's 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 patient's 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
