Donor-specific Anti-HLA Antibodies Monitoring in Kidney Transplant Recipients

Medical University of Warsaw

Status: Unknown

Conditions: Kidney Transplant Rejection

Treatments: Diagnostic Test: Anti-HLA donor-specific antibodies monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT03714113

DI2017 002147

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

100 participants in 1 patient group

Kidney transplant recipients.

Experimental group

Description:

Patients who undergo kidney transplant in 2018 or 2019.

Treatment:

Diagnostic Test: Anti-HLA donor-specific antibodies monitoring