An observational study in Membranous Nephropathy, Minimal Change Disease (MCD) and Focal Segmental Glomerulosclerosis (FSGS), sponsored by University Hospital, Ioannina. Completed at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by University Hospital, Ioannina · Observational
Immunophenotyping profiling of patients with primary MN, primary FSGS and MCD. Evaluation of these immune cell subsets as possible biomarkers to track response to treatment or disease relapse.
Primary nephrotic syndrome caused by membranous nephropathy (MN), focal segmental glomerulosclerosis (FSGS), or minimal change disease (MCD) is, in each case, associated with dysregulation of specific innate and adaptive immune cell populations. However, the relationship between circulating immune cell subsets and key clinical outcomes, specifically treatment response and disease relapse, remains incompletely defined, and the classical clinical and laboratory markers currently used to monitor these diseases are non-specific and have limited predictive value.
The principal parameter used clinically to monitor treatment response remains 24-hour urinary protein excretion. Complete remission is defined as a reduction in proteinuria to below 0.3 g/24h, and partial remission as a reduction of ≥50% from baseline together with total proteinuria below 3.5 g/24h. Non-response is defined as persistent proteinuria above 3.5 g/24h despite guideline-directed therapy, and relapse as recurrence of proteinuria above 3.5 g/24h in a patient who had previously achieved complete remission.
In MN specifically, serum anti-PLA2R antibody titers provide an additional marker of immunological disease activity: a decline in antibody levels can precede and predict clinical response, while re-emergence or a rise in titer in a patient previously in remission can predict relapse.
Despite the established contribution of specific immune cell populations to primary nephrotic syndrome, the literature remains comparatively sparse regarding abnormalities in regulatory T-cell subsets, monocyte subsets, B-cell subsets (including CD5+ B cells), T-helper subsets, and NK cells, and their potential role in disease pathogenesis across MN, MCD, and FSGS. Furthermore, classical clinical and immunological biomarkers of disease activity and treatment response are non-specific, correlate poorly with the degree of underlying renal injury, and in most cases cannot predict renal outcome. Anti-PLA2R1 antibody titers capture humoral activity and glomerular injury, but only partially explain this heterogeneity, are informative in only 70-80% of patients and frequently lag behind cellular events.
Whether changes in specific circulating immune cell subsets are associated with clinical outcomes in primary nephrotic syndrome, and whether they add predictive value beyond classical markers, remains an open question that this study is designed to address.
This prospective, single-center cohort study will enroll adult patients with either de novo or relapsing primary MN, primary FSGS and MCD, diagnosed by renal biopsy , who underwent rituximab (RTX) or corticosteroids treatment at the University Hospital of Ioannina between JUN 2023 and NOV 2025. Baseline was defined as the time of treatment initiation.
Baseline Assessment - Month 0
After baseline serum creatinine, eGFR (CKD-EPI), albumin, urine protein-to-creatinine ratio (UPCR), urine albumin-to-creatinine ratio (UACR), lipid parameters and inflammatory markers (ESR, CRP) were measured every month after treatment.
Anti-PLA2R antibody levels were measured at baseline and months 3,6 and 12 respectively.
Peripheral-blood immune-cell subsets were analysed by flow cytometry at baseline and at months 3, 6 and 12.
The following immune cell subsets were measured through flow cytometry:
The study aims to determine whether baseline levels and treatment-related changes in these immune cell subsets are associated with treatment response and disease relapse, and to correlate them with standard clinical and laboratory markers of renal function and disease activity.
144 studies on the registry are indexed under Glomerulonephritis, Membranous; 58 are open to participants now.
This study's enrollment of 40 is below the median of 120 across 35 observational studies indexed under Glomerulonephritis, Membranous.
Browse Glomerulonephritis, Membranous studies →University Hospital, Ioannina is the lead sponsor of 13 studies on the registry; 4 are open to participants now.
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Adult patients with primary MN, MCD and primary FSGS
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with primary MN
Drug: Rituximab (MABTHERA® or RITUXAN®).
Patients with primary focal segmental glomerulosclerosis
Drug: Corticosteroids (CS)
Patients with minimal change disease
Drug: Corticosteroids (CS)
Patients with primary MN treated with Rituximab
Patients with MCD treated with Corticosteroids
Patients with primary FSGS treated with Corticosteroids
Partial Remission
Urine protein to creatinine ratio\< 3.5 g/g and \>50 % reduction from baseline
Time frame: 12 months
Complete Remission
Urine protein to creatinine ratio \<0.3 g/g
Time frame: 12 months
Relapse
Urine protein to creatinine ratio\>3.5 g/g
Time frame: 24 months
Composite renal outcome
\>50% decline in eGFR (CKD-EPI) from baseline, and/or initiation of kidney replacement therapy
Time frame: 24 months
Cardiovascular events
Incident cardiovascular events during follow-up
Time frame: 24 months
Thromboembolic events
Incident venous or arterial thromboembolic events
Time frame: 24 months
Infections
Incident infections requiring medical evaluation or treatment
Time frame: 24 months
Hospitalization
All-cause hospitalization
Time frame: 24 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Summary Statistics including tables, figures and advanced statistics results (univariate/multivariate logistic regression results and kaplan meier survival analysis)
Supporting information: Study protocol
Access criteria: Data regarding methods and results presented in this study are available upon reasonable request from the primary investigator.
Ran from Jun 2023 to primary completion in Nov 2025, 29 months.
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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Glomerulonephritis, Membranous →
University Hospital, Ioannina