Understanding how intestinal immune cells contribute to the development and activity of IgA nephropathy

The role of intestinal mucosal B cells in the pathogenesis and activity of IgA nephropathy

Registry ID
ISRCTN11448420
Source registry
ISRCTN
Status
Recruiting
Study type
OBSERVATIONAL
Sponsor
Fundamental and Applied Research Projects in Latvia
Enrollment
60
Start date
2026-04-01
Completion date
2027-12-31
Last update
2026-08-17

Conditions

Summary

IgA nephropathy

Detailed description

This is an observational quantitative cross-sectional study including patients with biopsy-proven IgA nephropathy and controls from the general population. Blood, urine, and intestinal biopsy samples (Peyer’s patches) will be collected during colonoscopy. Peripheral blood mononuclear cells and intestinal immune cells will be isolated and analyzed using flow cytometry, ELISA, and RNA sequencing (bulk RNA-seq and single-cell RNA sequencing) to characterize B cell subpopulations and GdIgA1 production. In vitro B cell stimulation and co-culture models will be used to evaluate mechanisms of GdIgA1 production and B cell activation. Immunofluorescence microscopy will be used to analyze intestinal lymphoid tissue. Clinical and laboratory data will be collected and compared between study groups. Statistical analysis will be performed to identify differences between groups and associations between immunological markers and disease activity.

Interventions

Inclusion criteria

Cases – IgAN group: 1. Adults (≥18 years) 2. Biopsy-proven IgA nephropathy 3. eGFR ≥45 ml/min/1.73 m² 4. Proteinuria <1 g/day 5. Indication for colonoscopy (anemia, change in bowel habits, abdominal pain, positive fecal occult blood test) Controls: 1. Adults (≥18 years) 2. Individuals from general population undergoing screening colonoscopy 3. Positive fecal occult blood test 4. No pathological findings in colonoscopy (no polyps, tumors, inflammation)

Exclusion criteria

1. Age <18 years 2. Pregnancy or breastfeeding 3. Secondary IgA nephropathy 4. IgA vasculitis 5. Liver disease 6. Alcoholism 7. Type 1 or type 2 diabetes mellitus 8. Chronic inflammatory diseases 9. Malignancy 10. Acute myocardial infarction or stroke within the last 6 months 11. Active gastrointestinal bleeding For control group: polyps, tumors, or inflammatory changes detected during colonoscopy

Locations

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