The objective of the current study is to determine whether the presence of donor-specific B cell memory determines whether a patient will develop graft rejection or inferior graft function, especially in kidney transplant recipients who have donor-…
ID
Source
Brief title
Condition
- Other condition
- Nephropathies
Synonym
Health condition
orgaantransplantatie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main parameter to be assessed in the current study is the frequency of
donor-specific memory B cells as determined by a novel ELISPOT based technique.
Furthermore, donor-specific antibody levels will be determined by CDC and
Luminex techniques.
Secondary outcome
The secondary study parameters are clinical parameters. The transplant function
at 6 and 12 months will be determined by using the estimated Glomerular
Filtration Rate (eGFR). Furthermore, the occurence of cellular and antibody
mediated rejection within the first year after transplantation will be
recorded,
Background summary
Determining the risk of rejection prior to organ transplantation is an
important aspect of the transplant procedure, especially in immunised patients.
Historically, donor-specific antibodies are detected in the serum of the
patient by using a complement dependent cytotoxicity (CDC) assay. This assay
has been used ever since to prevent hyper-acute rejection. Recently, novel
techniques for the detection of donor-specific antibodies have been introduced,
based on the binding of antibodies to synthetic HLA molecules on polystyrene
beads (Luminex). Although this technique is much more sensitive in detecting
donor-specific antibodies, the clinical relevance of the detected antibodies is
currently unknown. In some patients the presence of antibodies only detected by
Luminex is associated with early rejection, while in others no negative effect
of these antibodies are observed. We hypothesise that the presence of
donor-specific memory B cells underlies this divergence. We have recently
developed a novel technique to determine the frequency of HLA-specific memory B
cells in the circulation of transplant patients and will use this technique to
determine the donor-specific B cell load in immunised transplant recipients.
Study objective
The objective of the current study is to determine whether the presence of
donor-specific B cell memory determines whether a patient will develop graft
rejection or inferior graft function, especially in kidney transplant
recipients who have donor-specific antibodies only detectable with the Luminex
technique.
Study design
The current study is a pilot study to determine whether the newly developed
HLA-specific memeory B cell ELISPOT assay provides clinically useful
information for risk assessment of (immunised) kidney transplant recipients.
Study burden and risks
There are no risks involved in participation in this study. There are also no
direct benefits for the participating patients.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Kidney transplant recipients who receive a kidney transplant after having rejected their previous transplant. Additionally, thier kidney donors in case of living donor transplantation.
Exclusion criteria
Subjects infected with HIV or Hepatitis C
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 | NL42616.058.12 |