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

Not Applicable

• Conditions: Kidney Transplant Rejection
• Interventions: Diagnostic Test: Anti-HLA donor-specific antibodies monitoring

• Registration Number: NCT03714113
• Lead Sponsor: Medical University of Warsaw

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.

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2018-10-03
• Study First Submitted QC: 2018-10-17
• Study First Posted: 2018-10-22
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-09
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Kidney transplant recipients.	Anti-HLA donor-specific antibodies monitoring	Patients who undergo kidney transplant in 2018 or 2019.

Primary Outcome Measures

Name	Time	Method
Presence of anti-HLA donor-specific antibodies.	24 months	Binary variable (positive/negative).

Secondary Outcome Measures

Name	Time	Method
Presence of IgG2 subclass of anti-HLA DSA.	24 months	Assessed when anti-HLA DSA positive. Binary variable (positive/negative).
Presence of IgG3 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 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).
Presence of IgG4 subclass of anti-HLA DSA.	24 months	Assessed when anti-HLA DSA positive. Binary variable (positive/negative).

Trial Locations

Locations (1)

Department of Transplantation Medicine, Nephrology and Internal Medicine; 🇵🇱 Warsaw, Poland