Kidney Transplant Rejection
Conditions
Keywords
Donor-specific antibodies
Brief summary
The aim of this study is to evaluate whether anti-HLA donor-specific antibodies monitoring can be used as an effective tool for stratification of immunological risk in Polish kidney transplant recipients.
Detailed description
Monitoring of immune response is one of the most important goals in the management of the patients after kidney transplantation. Researchers and clinicians are trying to extend the survival of the renal graft. Currently, it is believed that the main cause of late transplant loss is antibody-mediated rejection (ABMR). Anti-HLA donor-specific antibodies (DSA) are a proven risk factor for the development of humoral rejection and transplant loss. Antibodies in sensitized recipients occur before transplantation (preformed) or may develop de novo (in 13% -30% of patients). DSA damage the graft in various mechanisms (complement activation, direct influence on endothelial cells, antibody-dependent cytotoxicity) leading to different clinical-morphological phenotypes. The pathogenicity of DSA is determined by number of their additional characteristics, such as: class, specificity, strength, C1q complement binding, IgG subclass . Monitoring the presence of DSA in the kidney recipient serum with the determination of their characteristics may improve the stratification of the risk of immunological loss of the renal allograft. There is no effective treatment for ABMR, hence DSA monitoring allows for early intervention such as biopsy or modification of immunosuppressive therapy at an early stage of rejection.
Interventions
DIAGNOSTIC_TESTAnti-HLA donor-specific antibodies monitoring
Monitoring anti-HLA donor-specific antibodies in the patients serum at the time of kidney transplantation and 3, 12 and 24 months after the procedure. Blood samples from patients will be collected.
Sponsors
Ministry of Science and Higher Education, Poland
Medical University of Warsaw
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Deceased-donor kidney transplant recipient * Older than 18 years * Written consent by the patient
Exclusion criteria
* Younger than 18 years * Lack of written consent by the patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of anti-HLA donor-specific antibodies. | 24 months | Binary variable (positive/negative). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of C1q complement binding anti-HLA DSA. | 24 months | Assessed when anti-HLA DSA positive. Binary variable (positive/negative). |
| Presence of IgG1 subclass of anti-HLA DSA. | 24 months | Assessed when anti-HLA DSA positive. Binary variable (positive/negative). |
| Mean fluorescence intensity (MFI) of anti-HLA DSA. | 24 months | Assessed when anti-HLA DSA positive. Mean fluorescence intensity (MFI) of anti-HLA DSA. \[units\] |
| Presence of IgG3 subclass of anti-HLA DSA. | 24 months | Assessed when anti-HLA DSA positive. Binary variable (positive/negative). |
| Presence of IgG4 subclass of anti-HLA DSA. | 24 months | Assessed when anti-HLA DSA positive. Binary variable (positive/negative). |
| Presence of IgG2 subclass of anti-HLA DSA. | 24 months | Assessed when anti-HLA DSA positive. Binary variable (positive/negative). |
Countries
Poland
Outcome results
None listed