Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05894512
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2023-05-31
Brief Title:
Analysis of T- and B-Cell Subpopulations in Membranous Nephropathy
Sponsor:
Istanbul University
Organization:
Istanbul University
Study Overview
Official Title:
Analysis of T- and B-Cell Subpopulations in Patients With Primary Membranous Nephropathy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this observational study is to provide analysis of T and B lymphocyte subgroups in peripheral blood samples of patients with primary membranous nephropathy MN A search for disease-related circulating antibodies anti-phospholipase A2 receptor antibody anti-PLA2R and anti-thrombospondin type 1 domain-containing 7A antibody anti-THSD7A in patients sera is also planned
The main questions to answer are
1 What is the relationship of these cell populations and their distribution during follow-up with treatment treatment responses and relapses
2 What is the relationship of the cell populations with anti-PLA2R or anti-THSD7A antibody levels
Participants will provide peripheral venous blood samples at pre-designated regular intervals
The research team will compare results of the primary MN group with two control groups IgA nephropathy and healthy volunteer groups to see if the findings are specific for primary MN
The main questions to answer are
1 What is the relationship of these cell populations and their distribution during follow-up with treatment treatment responses and relapses
2 What is the relationship of the cell populations with anti-PLA2R or anti-THSD7A antibody levels
Participants will provide peripheral venous blood samples at pre-designated regular intervals
The research team will compare results of the primary MN group with two control groups IgA nephropathy and healthy volunteer groups to see if the findings are specific for primary MN
Detailed Description:
Primary membranous nephropathy MN which is one of the most common causes of nephrotic syndrome in adults is an autoimmune disease characterized with remissions and exacerbations About half of the patients who do not go into remission progress to end-stage kidney disease
In recent years a lot of progress has been made in the fields of nephrology and immunology regarding primary MN The process which began with the detection of autoantibodies against the M-type phospholipase A2 receptor PLA2R in approximately 70 of the patients continued with the discovery of new molecules for diagnosis and follow-up However despite all these advances studies based on the analysis of peripheral blood mononuclear cells in patients with primary MN are very few Rosenzwajg et al analyzed lymphocyte subgroups in 25 MN patients and 27 healthy controls and showed that regulatory T cells were significantly decreased in patients naive B cells were increased and memory B cells were decreased Rosenzwajg et al Kidney Int 2017 In 2020 Cantarelli et al performed an extensive analysis in 30 patients with MN showing that regulator B cells were increased in the MN group Cantarelli et al Kidney Int Rep 2020 These studies were generally cross-sectional or sampling was performed at a maximum of 6 months of follow-up More studies based on long-term follow-up are needed
Therefore the aim of this observational study is to provide analysis of T and B lymphocyte subgroups in peripheral blood samples of patients with primary MN A search for disease-related circulating antibodies anti-phospholipase A2 receptor antibody anti-PLA2R and anti-thrombospondin type 1 domain-containing 7A antibody anti-THSD7A in patients sera is also planned It is designed to investigate the relationship of these cell populations and their distribution during follow-up with treatment treatment responses and relapses The relationship of cell populations with antibody levels over time will also be examined
By investigating the distribution of T and B lymphocyte subgroups in patients with primary MN during the follow-up and its relationship with treatment treatment responses and relapses it is expected to better elucidate the pathogenesis of the disease and to detect cell changes suggestive of remission and recurrence
In recent years a lot of progress has been made in the fields of nephrology and immunology regarding primary MN The process which began with the detection of autoantibodies against the M-type phospholipase A2 receptor PLA2R in approximately 70 of the patients continued with the discovery of new molecules for diagnosis and follow-up However despite all these advances studies based on the analysis of peripheral blood mononuclear cells in patients with primary MN are very few Rosenzwajg et al analyzed lymphocyte subgroups in 25 MN patients and 27 healthy controls and showed that regulatory T cells were significantly decreased in patients naive B cells were increased and memory B cells were decreased Rosenzwajg et al Kidney Int 2017 In 2020 Cantarelli et al performed an extensive analysis in 30 patients with MN showing that regulator B cells were increased in the MN group Cantarelli et al Kidney Int Rep 2020 These studies were generally cross-sectional or sampling was performed at a maximum of 6 months of follow-up More studies based on long-term follow-up are needed
Therefore the aim of this observational study is to provide analysis of T and B lymphocyte subgroups in peripheral blood samples of patients with primary MN A search for disease-related circulating antibodies anti-phospholipase A2 receptor antibody anti-PLA2R and anti-thrombospondin type 1 domain-containing 7A antibody anti-THSD7A in patients sera is also planned It is designed to investigate the relationship of these cell populations and their distribution during follow-up with treatment treatment responses and relapses The relationship of cell populations with antibody levels over time will also be examined
By investigating the distribution of T and B lymphocyte subgroups in patients with primary MN during the follow-up and its relationship with treatment treatment responses and relapses it is expected to better elucidate the pathogenesis of the disease and to detect cell changes suggestive of remission and recurrence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None