NCT03714113

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

Clinical Significance of Donor-specific Anti-HLA Antibodies Monitoring in Kidney Transplant Recipients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Transplant Rejection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Anti-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.

Timeline

• Start date: 2018-10-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2018-10-22
• Last updated: 2021-03-09

Locations

1 site across 1 country: Poland