Clinical trial NCT03714113: Donor-specific Anti-HLA Antibodies Monitoring in Kidney Transplant Recipients
Official title: Clinical Significance of Donor-specific Anti-HLA Antibodies Monitoring in Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Transplant Rejection
Keywords: Donor-specific antibodies
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Higher Education, Poland
First posted: 2018-10-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of anti-HLA donor-specific antibodies.
timeFrame: 24 months
Secondary outcomes:
measure: Mean fluorescence intensity (MFI) of anti-HLA DSA.
timeFrame: 24 months
measure: Presence of C1q complement binding anti-HLA DSA.
timeFrame: 24 months
measure: Presence of IgG1 subclass of anti-HLA DSA.
timeFrame: 24 months
measure: Presence of IgG2 subclass of anti-HLA DSA.
timeFrame: 24 months
measure: Presence of IgG3 subclass of anti-HLA DSA.
timeFrame: 24 months
measure: Presence of IgG4 subclass of anti-HLA DSA.
timeFrame: 24 months
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Transplantation Medicine, Nephrology and Internal Medicine
Study officials:
References: