To determine 1) the incidence of ABMR and mixed ABMR / T cell-mediated rejection (TCMR) in immunological high-risk kidney transplant recipients treated with the currently prevailing immunosuppressive regimens, 2) to relate ABMR and mixed-type…
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoints are the incidence of ABMR, the incidence of mixed
ABMR/TCMR, and kidney function after at least one year of follow-up.
Secondary outcome
In addition, the immune system will be mapped with a focus on B cell function,
the development of (non-)HLA antibodies, the interaction between B cells and T
follicular helper cells, and complete immune phenotypic profiling.
Background summary
Despite improved patient and graft survival of kidney transplant recipients, as
much as 20% of these patients will again reach end-stage kidney disease within
5 years after transplantation. Antibody-mediated rejection (ABMR) is one of the
major causes of early graft loss and perhaps even more important, of late
deterioration of graft function.
Study objective
To determine 1) the incidence of ABMR and mixed ABMR / T cell-mediated
rejection (TCMR) in immunological high-risk kidney transplant recipients
treated with the currently prevailing immunosuppressive regimens, 2) to relate
ABMR and mixed-type rejection to clinical outcome (graft survival, function,
proteinuria, histology), and 3) to test novel state-of-the-art immunological
assays in a clinical setting.
Study design
Prospective cohort study.
Study burden and risks
Limited benefits or risks are associated with participation in this study since
this study is a prospective observational clinical cohort study and all
patients will receive standard of care. The only possible adverse event will be
mild discomfort or a local hematoma resulting from the venous puncture
necessary for the drawing of blood.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- >=18 years old
- About to receive a deceased donor or living donor renal transplant
- Provide informed consent
- Immunological high risk for rejection
a. Luminex positive DSAs (Immucor background corrected MFI >500)8;
and/or
b. Re-transplantation with repeated mismatch; and/or
c. Husband to wife donation (after fathering children); and/or
d. Offspring to mother donation
The healthy subjects are the living donors of aforementioned patients, they
have to meet the following criteria,
- >=18 years old
- About to donate a kidney as a living donor
- Provide informed consent
Exclusion criteria
A potential subject who meets the following criterium will be excluded from
participation in this study:
- Regular follow-up after transplantation is not feasible
- AB0-incompatible or HLA-incompatible kidney transplantation
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 |
|---|---|
| ClinicalTrials.gov | NCT05140018 |
| CCMO | NL76773.042.21 |