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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03714113
Other study ID # DI2017 002147
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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