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

Kidney Transplant Rejection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03714113
• Other study ID #: DI2017 002147
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: December 2021

Study information

• Verified date: March 2021
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplant Rejection

Intervention

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.

Locations

Country	Name	City	State
Poland	Department of Transplantation Medicine, Nephrology and Internal Medicine	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Warsaw	Ministry of Science and Higher Education, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of anti-HLA donor-specific antibodies.	Binary variable (positive/negative).	24 months
Secondary	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
Secondary	Presence of C1q complement binding anti-HLA DSA.	Assessed when anti-HLA DSA positive. Binary variable (positive/negative).	24 months
Secondary	Presence of IgG1 subclass of anti-HLA DSA.	Assessed when anti-HLA DSA positive. Binary variable (positive/negative).	24 months
Secondary	Presence of IgG2 subclass of anti-HLA DSA.	Assessed when anti-HLA DSA positive. Binary variable (positive/negative).	24 months
Secondary	Presence of IgG3 subclass of anti-HLA DSA.	Assessed when anti-HLA DSA positive. Binary variable (positive/negative).	24 months
Secondary	Presence of IgG4 subclass of anti-HLA DSA.	Assessed when anti-HLA DSA positive. Binary variable (positive/negative).	24 months