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

Sponsor

Medical University of Warsaw (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03714113

Collaborator

Ministry of Science and Higher Education, Poland (Other)

100

Enrollment

Location

Arm

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplant Rejection	Diagnostic Test: Anti-HLA donor-specific antibodies monitoring	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Oct 1, 2018

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Presence of anti-HLA donor-specific antibodies. [24 months]
Binary variable (positive/negative).

Secondary Outcome Measures

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 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).
Presence of IgG4 subclass of anti-HLA DSA. [24 months]
Assessed when anti-HLA DSA positive. Binary variable (positive/negative).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Transplantation Medicine, Nephrology and Internal Medicine	Warsaw		Poland	02-006

Sponsors and Collaborators

Medical University of Warsaw
Ministry of Science and Higher Education, Poland

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medical University of Warsaw

ClinicalTrials.gov Identifier:

NCT03714113

Other Study ID Numbers:

DI2017 002147

First Posted:

Oct 22, 2018

Last Update Posted:

Mar 9, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Medical University of Warsaw

Donor-specific antibodies

Additional relevant MeSH terms:

Antibodies

Study Results

No Results Posted as of Mar 9, 2021