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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Kidney Transplant Rejection
• Intervention / Treatment: Diagnostic test: Anti-HLA donor-specific antibodies monitoring

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 02-006
    • Department of Transplantation Medicine, Nephrology and Internal Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kidney transplant recipients.; Patients who undergo kidney transplant in 2018 or 2019.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of anti-HLA donor-specific antibodies.	Binary variable (positive/negative).	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean fluorescence intensity (MFI) of anti-HLA DSA.	Assessed when anti-HLA DSA positive. Mean fluorescence intensity (MFI) of anti-HLA DSA. [units]	24 months
Presence of C1q complement binding anti-HLA DSA.	Assessed when anti-HLA DSA positive. Binary variable (positive/negative).	24 months
Presence of IgG1 subclass of anti-HLA DSA.	Assessed when anti-HLA DSA positive. Binary variable (positive/negative).	24 months
Presence of IgG2 subclass of anti-HLA DSA.	Assessed when anti-HLA DSA positive. Binary variable (positive/negative).	24 months
Presence of IgG3 subclass of anti-HLA DSA.	Assessed when anti-HLA DSA positive. Binary variable (positive/negative).	24 months
Presence of IgG4 subclass of anti-HLA DSA.	Assessed when anti-HLA DSA positive. Binary variable (positive/negative).	24 months

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Collaborators: Ministry of Science and Higher Education, Poland

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: October 3, 2018
• First Submitted That Met QC Criteria: October 17, 2018
• First Posted (Actual): October 22, 2018

Study Record Updates

• Last Update Posted (Actual): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Donor-specific antibodies
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: DI2017 002147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No