The objective is to characterize intrarenal T cells isolated from transplant biopsies both phenotypically and functionally.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
orgaantransplantatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters will be the number and characterization of intrarenal
T cells in cases of chronic kidney allograft rejection.
Secondary outcome
Intrarenal T cells isolated from cases with chronic rejection will be compared
to those isolated from individuals with chronic interstitial fibrosis without
evidence for rejection.
Background summary
The number of patients reaching end-stage renal disease requiring renal
replacement therapy grows every year. Kidney transplantation is the preferred
option in these patients but donor organs are scarce. After kidney
transplantation, the most frequent cause of progressive loss of the transplant
is chronic rejection. Recent studies have shown that the cellular part of the
immune system is involved and the degree of intrarenal inflammation is the
dominant predictor of graft loss. Previous research of our group showed that
so-called T cells are involved but further functional characterization of these
cells is needed to understand their nature and possible therapeutic options.
Study objective
The objective is to characterize intrarenal T cells isolated from transplant
biopsies both phenotypically and functionally.
Study design
Recipients of a kidney transplantation undergoing a diagnostic renal biopsy
will have an extra biopsy. The tissue obtained from this extra biopsy will be
processed to obtain a single cell population. The individual cells (T cells,
other immune cells, endothelial cells, renal cells) will be characterised by
flow cytometry and T cells will be isolated for functional characterization.
The functional test of these cells will include the assessment of the
reactivity to donor cells and their capacity to promote fibrosis.
Intervention
A diagnostic kidney biopsy procedure will be performed and in addition an extra
biopsy will be taken for research purposes.
In addition, the patients will be asked to give 50 ml of heparin blood to
obtain mononuclear cells from, needed to perform the functional assays.
Study burden and risks
The burden and risks associated with participation are related to the extra
renal biopsy. The kidney transplant is located superficially in the ileac fossa
and can be easily accessed for renal biopsy with adequate local anaesthesia.
Therefore, the procedure is not considered painful by patients and the risk for
bleeding is very low. This procedure is performed frequently (>400 times per
year) at the radiology department of the Erasmus MC.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
-18 years and older
-able to give informed consent
-clinical diagnosis of chronic rejection for which a renal biopsy is indicated
for confirmation
Exclusion criteria
-known extra risk for bleeding (e.g. clotting disorder or medication)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL69727.078.19 |