An observational study in IgA Nephropathy, sponsored by Bezmialem Vakif University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Bezmialem Vakif University · Observational
IgA nephropathy is a common primary glomerular disease with a highly variable clinical course. Soluble CD163 is a marker associated with monocyte and macrophage activation and may reflect inflammatory activity in kidney disease. This single-center observational study aims to evaluate the associations of serum and urinary soluble CD163 levels with clinical disease activity, histopathologic severity, and renal prognosis in patients with IgA nephropathy. Clinical, laboratory, and kidney biopsy findings will be assessed together with serum and urinary soluble CD163 measurements. Participants will also be followed for renal outcomes, including changes in kidney function and proteinuria. The study is expected to clarify whether soluble CD163 may serve as a noninvasive biomarker of disease activity and prognosis in IgA nephropathy.
This is a single-center observational study involving patients with biopsy-proven IgA nephropathy. The study includes both retrospectively collected clinical and histopathologic data and prospectively collected follow-up data, in accordance with the approved study protocol. Serum and urinary soluble CD163 levels will be measured and evaluated in relation to demographic characteristics, kidney function, proteinuria, hematuria, and other relevant laboratory parameters.
Histopathologic severity will be assessed using kidney biopsy findings, including Oxford MEST-C classification components where available. Associations between soluble CD163 levels and markers of disease activity, histopathologic lesions, and renal outcomes will be examined. Follow-up assessments will include changes in estimated glomerular filtration rate, serum creatinine, and proteinuria, as well as other predefined renal outcomes.
No study-specific therapeutic intervention will be assigned. All treatment decisions will be made by the treating physicians according to routine clinical practice. The study is designed to investigate the potential value of serum and urinary soluble CD163 as biomarkers of disease activity, histopathologic severity, and prognosis in IgA nephropathy.
275 studies on the registry are indexed under Glomerulonephritis, IGA; 107 are open to participants now.
This study's enrollment of 87 is below the median of 245 across 45 observational studies indexed under Glomerulonephritis, IGA.
Browse Glomerulonephritis, IGA studies →Bezmialem Vakif University is the lead sponsor of 354 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults aged 18 years or older followed at Bezmialem Vakif University with biopsy-proven primary IgA nephropathy or primary focal segmental glomerulosclerosis, together with age- and sex-matched healthy controls without known chronic disease and with normal kidney function. Clinical, laboratory, histopathologic, biomarker, treatment, and follow-up data will be collected according to the approved observational study protocol.
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.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
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.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
Patients with biopsy-proven IgA nephropathy who undergo assessment of serum and urinary soluble CD163 levels together with clinical, laboratory, histopathologic, and follow-up data. No study-specific therapeutic intervention is assigned, and treatment decisions are made according to routine clinical practice.
Patients with biopsy-proven focal segmental glomerulosclerosis who undergo assessment of serum and urinary soluble CD163 levels together with relevant clinical, laboratory, histopathologic, and follow-up data. This group serves as a disease control group. No study-specific therapeutic intervention is assigned.
Healthy individuals without known kidney disease who undergo serum and urinary soluble CD163 measurement and relevant clinical and laboratory assessment. This group serves as a healthy control group.
Comparison of Serum and Urinary Soluble CD163 Levels Among IgAN, FSGS, and Healthy Control Groups
Serum soluble CD163 concentration, urinary soluble CD163 concentration, and urinary soluble CD163 normalized to urinary creatinine will be compared among participants with biopsy-proven IgA nephropathy, participants with biopsy-proven focal segmental glomerulosclerosis, and healthy controls. Soluble CD163 levels will be measured using a commercially available ELISA kit.
Time frame: At baseline sample collection
Association of Soluble CD163 Levels With Clinical Disease Activity in IgA Nephropathy
Associations of serum and urinary soluble CD163 levels with proteinuria, hematuria, serum creatinine, estimated glomerular filtration rate, and other clinical indicators of disease activity will be evaluated in participants with biopsy-proven IgA nephropathy.
Time frame: At baseline assessment
Association of Soluble CD163 Levels With Histopathologic Severity
Associations of serum and urinary soluble CD163 levels with Oxford MEST-C parameters in IgA nephropathy and with segmental sclerosis and tubulointerstitial fibrosis findings in focal segmental glomerulosclerosis will be evaluated.
Time frame: At baseline kidney biopsy assessment
Plan to share: No — Individual participant data will not be shared because data sharing was not included in the approved study protocol or informed consent documents.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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