IgA NephropathySCD163-IgANNCT07754019
Serum and Urinary sCD163 in IgA Nephropathy
An observational study of IgA Nephropathy, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- IgA Nephropathy
- How many people
- 87 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Feb 2025to 1 Sep 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: 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.
Who may be able to join
- - Age 18 years or older
- Biopsy-proven primary IgA nephropathy or primary focal segmental glomerulosclerosis
- Stable kidney function with an estimated glomerular filtration rate greater than 30 mL/min/1.73 m²
- Availability of serum and urine samples for soluble CD163 measurement
- Availability of relevant demographic, clinical, laboratory, histopathologic, and follow-up data
- For the healthy control group: age- and sex-matched individuals without known chronic disease and with normal kidney function
- Written informed consent
Who cannot join
- - Secondary IgA nephropathy or secondary focal segmental glomerulosclerosis
- Active infection
- Acute kidney injury
- End-stage kidney disease or ongoing dialysis treatment
- Estimated glomerular filtration rate below 15 mL/min/1.73 m²
- Recent use of corticosteroids or immunosuppressive therapy
Show all 11Show fewer
- Pregnancy
- Active malignancy or history of malignancy
- Inadequately stored or unavailable serum and/or urine samples
- Missing essential clinical, laboratory, histopathologic, or follow-up data
- Absence of written informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University Health Application and Research Center
Istanbul, 34093
About this study
Official title: Association of Serum and Urinary Soluble CD163 Levels With Disease Activity, Histopathologic Severity, and Prognosis in Patients With IgA Nephropathy: A Single-Center Observational Study
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.
Read the detailed description
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.
- Conditions
- IgA Nephropathy
- Keywords
- Soluble CD163, Oxford MEST-C Classification, Proteinuria, Renal Prognosis, sCD163, Urinary Biomarker, Serum Biomarker, IgA Nephropathy, Kidney Biopsy
- Medical subject headings
- Glomerulonephritis, IGA, Proteinuria
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 |
|---|---|---|
| Patients With Biopsy-Proven IgA Nephropathy | 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 FSGS | 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 Controls | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline sample collection
Secondary outcomes (2)
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.
Measured: 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.
Measured: At baseline kidney biopsy assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start3 Feb 2025
- Primary completion1 Sep 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IgA NephropathyStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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
- Other
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Omer Celal Elcioglu, Professor, Study chair, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754019
- Sponsor's protocol ID
- IGAN-SCD163-2026
- Acronym
- SCD163-IgAN
- Status last verified
- Oct 2026
- First submitted
- 4 Aug 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because data sharing was not included in the approved study protocol or informed consent documents.
Publications
Gong S, Jin S, Li Y, Jiang W, Zhang Z, Shen Z, Wang J, Zhou H, Liu X, Xu X, Ding X, Shi Y, Liu H. Urinary Soluble CD163 Levels Predict IgA Nephropathy Remission Status. Front Immunol. 2021 Dec 23;12:769802. doi: 10.3389/fimmu.2021.769802. eCollection 2021.
PubMed 35003086
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Serum and Urinary Soluble CD163 Levels With Disease Activity, Histopathologic Severity, and Prognosis in Patients With IgA Nephropathy: A Single-Center Observational Study
- ClinicalTrials.gov ID
- NCT07754019
- Acronym / sponsor ID
- SCD163-IgAN / IGAN-SCD163-2026
- Conditions
- IgA Nephropathy
- Keywords
- Soluble CD163, Oxford MEST-C Classification, Proteinuria, Renal Prognosis, sCD163, Urinary Biomarker, Serum Biomarker, IgA Nephropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 10 Aug 2026 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients With Biopsy-Proven IgA Nephropathy | – | –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 FSGS | – | –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 Controls | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- - Age 18 years or older
- Biopsy-proven primary IgA nephropathy or primary focal segmental glomerulosclerosis
- Stable kidney function with an estimated glomerular filtration rate greater than 30 mL/min/1.73 m²
- Availability of serum and urine samples for soluble CD163 measurement
- Availability of relevant demographic, clinical, laboratory, histopathologic, and follow-up data
Key exclusion criteria (11 listed)
- - Secondary IgA nephropathy or secondary focal segmental glomerulosclerosis
- Active infection
- Acute kidney injury
- End-stage kidney disease or ongoing dialysis treatment
- Estimated glomerular filtration rate below 15 mL/min/1.73 m²
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
Comparison of Serum and Urinary Soluble CD163 Levels Among IgAN, FSGS, and Healthy Control Groups
Time frame: At baseline sample collection
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.
2 secondary outcomes
Association of Soluble CD163 Levels With Clinical Disease Activity in IgA Nephropathy
Time frame: At baseline assessment
Association of Soluble CD163 Levels With Histopathologic Severity
Time frame: At baseline kidney biopsy assessment
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 27 Oct 2026.
- Background: PubMed 35003086Gong S, Jin S, Li Y, Jiang W, Zhang Z, Shen Z, Wang J, Zhou H, Liu X, Xu X, Ding X, Shi Y, Liu H. Urinary Soluble CD163 Levels Predict IgA Nephropathy Remission Status. Front Immunol. 2021 Dec 23;12:769802. doi: 10.3389/fimmu.2021.769802. eCollection 2021.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because data sharing was not included in the approved study protocol or informed consent documents.
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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.
Omer Celal Elcioglu, Professor study chair
Bezmialem Vakif 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 IgA Nephropathy, run by Bezmialem Vakif 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 7 inclusion and 11 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 27 Oct 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?
Comparison of Serum and Urinary Soluble CD163 Levels Among IgAN, FSGS, and Healthy Control Groups (time frame: At baseline sample collection). 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 NCT07754019, which also lists 1 linked publication.
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 27 Oct 2026.