Analysis of T- and B-Cell Subpopulations in Membranous Nephropathy

February 28, 2026 updated by: Safak Mirioglu, Istanbul University

Analysis of T- and B-Cell Subpopulations in Patients With Primary Membranous Nephropathy

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with biopsy-proven membranous nephropathy (study group) and IgA nephropathy (control group).

Description

Inclusion Criteria:

  • Having a diagnosis of primary membranous nephropathy (patient group).
  • Having a diagnosis of primary IgA nephropathy (diseased control group).
  • Being healthy (healthy control group).
  • Agreeing to participate in the research (informed consent).

Exclusion Criteria:

  • Refusing to participate in the research.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Study Group (Primary Membranous Nephropathy)

Patients with biopsy-proven primary membranous nephropathy will be included (n=18).

Samples will be collected from patients diagnosed with primary MN before starting conventional immunosuppressive therapy with calcineurin inhibitors (CNI) and corticosteroids (CS) and at 3, 6, 12, 18 and 24 months after starting the treatment.

In case of failure after treatment with CNIs and CS treatment, rituximab (RTX) is used. If patient switches to RTX, samples will be taken before and 1, 3, 6, 12, 18, and 24 months after the first dose of RTX.

If relapse occurs, sampling will be done regardless of the timing.

Treatment decisions will solely be made in line with the guidelines, and there will be no intervention.
Control Group 1 (IgA Nephropathy)

After the patient group sampling is completed, a diseased control group will be formed from patients with primary IgA nephropathy according to the distribution of age and sex (n=12).

Samples will be collected from the patients for one time only (cross-sectional sampling).
Control Group 2 (Healthy Volunteers)

After the patient group sampling is completed, a healthy control group will be formed from healthy volunteers according to the distribution of age and sex (n=14).

Samples will be collected from healthy volunteers for one time only (cross-sectional sampling).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distribution of T- and B-cell subpopulations
Time Frame: 2 years
Distribution of T- and B-cell subpopulations will be evaluated with flow cytometry throughout the 2-year follow-up process.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete remission
Time Frame: 2 years
Reduction of proteinuria to <0.3 g/g or g/day, stable serum creatinine, and serum albumin >3.5 g/dl.
2 years
Partial remission
Time Frame: 2 years
Reduction of proteinuria to 0.3-3.5 g/g or g/day with an at least a 50% decrease from the baseline.
2 years
Relapse
Time Frame: 2 years
Proteinuria of at least 3.5 g/g or g/day after complete or partial remission has been reached.
2 years
Composite kidney outcome
Time Frame: 2 years
Initiation of kidney replacement therapies (hemodialysis, peritoneal dialysis or kidney transplantation), development of stage 5 chronic kidney disease (eGFR <15 ml/min/1.73 m2), or at least a 50% loss in eGFR.
2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum anti-PLA2R IgG antibody levels
Time Frame: 2 years
Serum anti-PLA2R IgG antibody levels will be evaluated with enzyme-linked immunosorbent assay (ELISA) throughout the 2-year follow-up process.
2 years
Serum anti-THSD7A IgG antibody levels
Time Frame: 2 years
In PLA2R-negative patients, serum anti-THSD7A IgG antibody levels will be evaluated with indirect immunofluorescence test (IIFT) throughout the 2-year follow-up process.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Study Chair: Suzan Adin Cinar, PhD, Istanbul University
  • Principal Investigator: Safak Mirioglu, MD, Istanbul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

February 15, 2026

Study Completion (Actual)

February 15, 2026

Study Registration Dates

First Submitted

May 31, 2023

First Submitted That Met QC Criteria

May 31, 2023

First Posted (Actual)

June 8, 2023

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 28, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/887

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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