To select T cell properties intrinsic to the transplant recipient, which can discriminate between patients who will likely experience acute cellular rejection episodes from those who don*t.
ID
Source
Brief title
Condition
- Other condition
- Immune disorders NEC
- Genitourinary tract disorders NEC
Synonym
Health condition
rejectie na niertransplantatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
We expect to find a combination of read out paramters, measured in one assay ,
which before transplantation can discriminate between patients at risk for
acute cellular rejection and patients who are not.
Secondary outcome
Not apllicable
Background summary
Despite the essential role for T cells in the pathogenesis of acute allograft
rejection, as yet no clinical useful method to measure pre-existing
allospecific T cell immunity exists.
If such could be measured in a reliable way, tailor made immunosuppressive drug
therapy could finally become practice. Considering increasing morbidity due to
infections complicating the immunosuppressive state, a test to predict T cell
alloreactivity after transplantation would be a major step forward in
management of the renal transplant patient.
We now have much experience with the multiparameter MLC-CFSE-assay, which
enables to determine a combination of quantitative and qualitatieve properties
of alloreactive T cells in one assay. Preliminary data indicate that this test
is able to predict the posttranplant clinical course.
Study objective
To select T cell properties intrinsic to the transplant recipient, which can
discriminate between patients who will likely experience acute cellular
rejection episodes from those who don*t.
Study design
A retrospective study is currently being done to select parameters that
discriminate between patients with or without acute cellular rejection. These
parameters will be used during the prospective study.
The findings will be validated in a patientcohort that shifts at 6 months
post-transplantation from triple to double immunosuppressive drug treatment, as
part of current standard treatment.
This enables us to also evaluate the power of this test to predict
alloreactivity after diminution of immunosuppressive drug therapy.
Study burden and risks
For the analysis during this study, 3X42ml blood is needed. 42ml blood
pre-transplant, 42ml blood 6-month post-transplant and 42ml blood 12-month
post-transplant.
According to our experience the risk and burden are minimal.
Meibergdreef 9
1105 AZ
NL
Meibergdreef 9
1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Renal transplant recipients of a first or second graft,.
Exclusion criteria
Highly immunized paitents with panel reactive antibodies >85% will be excluded
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 | NL12588.018.06 |