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

NCT ID: NCT03714113

Last Updated: 2021-03-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2021-12-31

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.

Conditions

Kidney Transplant Rejection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Kidney transplant recipients.

Patients who undergo kidney transplant in 2018 or 2019.

Group Type: EXPERIMENTAL

Anti-HLA donor-specific antibodies monitoring

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Science and Higher Education, Poland

OTHER_GOV

Sponsor Role: collaborator

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Transplantation Medicine, Nephrology and Internal Medicine

Warsaw, , Poland

Countries

Poland

Other Identifiers

DI2017 002147

Identifier Type: -

Identifier Source: org_study_id