Membranous NephropathyNCT05894512
Analysis of T- and B-Cell Subpopulations in Membranous Nephropathy
An observational study of Membranous Nephropathy and Membranous Nephropathy - PLA2R Induced, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Membranous Nephropathy, Membranous Nephropathy - PLA2R Induced, Membranous Nephropathy - THSD7A Induced
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 15 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with biopsy-proven membranous nephropathy (study group) and IgA nephropathy (control group).
Who may be able to join
- 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).
Who cannot join
- Refusing to participate in the research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- What is the relationship of these cell populations and their distribution during follow-up with treatment, treatment responses, and relapses?
- 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.
Read the 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.
- Conditions
- Membranous Nephropathy, Membranous Nephropathy - PLA2R Induced, Membranous Nephropathy - THSD7A Induced
- Keywords
- membranous nephropathy, rituximab, flow cytometry, immunophenotyping, PLA2R
- Medical subject headings
- Glomerulonephritis, Membranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Distribution of T- and B-cell subpopulations
Distribution of T- and B-cell subpopulations will be evaluated with flow cytometry throughout the 2-year follow-up process.
Measured: 2 years
Secondary outcomes (4)
Complete remission
Reduction of proteinuria to <0.3 g/g or g/day, stable serum creatinine, and serum albumin >3.5 g/dl.
Measured: 2 years
Partial remission
Reduction of proteinuria to 0.3-3.5 g/g or g/day with an at least a 50% decrease from the baseline.
Measured: 2 years
Relapse
Proteinuria of at least 3.5 g/g or g/day after complete or partial remission has been reached.
Measured: 2 years
Composite kidney outcome
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start1 Jun 2023
- Primary completion15 Feb 2026
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Membranous NephropathyStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safak Mirioglu, Istanbul University
- Investigators
- Suzan Adin Cinar, PhD, Study chair, Istanbul UniversitySafak Mirioglu, MD, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894512
- Sponsor's protocol ID
- 2023/887
- Status last verified
- Jul 2026
- First submitted
- 31 May 2023
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rosenzwajg M, Languille E, Debiec H, Hygino J, Dahan K, Simon T, Klatzmann D, Ronco P. B- and T-cell subpopulations in patients with severe idiopathic membranous nephropathy may predict an early response to rituximab. Kidney Int. 2017 Jul;92(1):227-237. doi: 10.1016/j.kint.2017.01.012. Epub 2017 Mar 15.
PubMed 28318628Cantarelli C, Jarque M, Angeletti A, Manrique J, Hartzell S, O'Donnell T, Merritt E, Laserson U, Perin L, Donadei C, Anderson L, Fischman C, Chan E, Draibe J, Fulladosa X, Torras J, Riella LV, La Manna G, Fiaccadori E, Maggiore U, Bestard O, Cravedi P. A Comprehensive Phenotypic and Functional Immune Analysis Unravels Circulating Anti-Phospholipase A2 Receptor Antibody Secreting Cells in Membranous Nephropathy Patients. Kidney Int Rep. 2020 Aug 1;5(10):1764-1776. doi: 10.1016/j.ekir.2020.07.028. eCollection 2020 Oct.
PubMed 33102969
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of T- and B-Cell Subpopulations in Patients With Primary Membranous Nephropathy
- ClinicalTrials.gov ID
- NCT05894512
- Acronym / sponsor ID
- 2023/887
- Conditions
- Membranous Nephropathy, Membranous Nephropathy - PLA2R Induced, Membranous Nephropathy - THSD7A Induced
- Keywords
- membranous nephropathy, rituximab, flow cytometry, immunophenotyping, PLA2R
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the relationship of these cell populations and their distribution during follow-up with treatment, treatment responses, and relapses?
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with biopsy-proven membranous nephropathy (study group) and IgA nephropathy (control group).
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- Refusing to participate in the research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Complete remission
Time frame: 2 years
Partial remission
Time frame: 2 years
Relapse
Time frame: 2 years
Composite kidney outcome
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Background: PubMed 28318628Rosenzwajg M, Languille E, Debiec H, Hygino J, Dahan K, Simon T, Klatzmann D, Ronco P. B- and T-cell subpopulations in patients with severe idiopathic membranous nephropathy may predict an early response to rituximab. Kidney Int. 2017 Jul;92(1):227-237. doi: 10.1016/j.kint.2017.01.012. Epub 2017 Mar 15.
- Background: PubMed 33102969Cantarelli C, Jarque M, Angeletti A, Manrique J, Hartzell S, O'Donnell T, Merritt E, Laserson U, Perin L, Donadei C, Anderson L, Fischman C, Chan E, Draibe J, Fulladosa X, Torras J, Riella LV, La Manna G, Fiaccadori E, Maggiore U, Bestard O, Cravedi P. A Comprehensive Phenotypic and Functional Immune Analysis Unravels Circulating Anti-Phospholipase A2 Receptor Antibody Secreting Cells in Membranous Nephropathy Patients. Kidney Int Rep. 2020 Aug 1;5(10):1764-1776. doi: 10.1016/j.ekir.2020.07.028. eCollection 2020 Oct.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzan Adin Cinar, PhD study chair
Istanbul University
Safak Mirioglu, MD principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Membranous Nephropathy and Membranous Nephropathy - PLA2R Induced, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of T- and B-cell subpopulations (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05894512, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.