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Uromodulin as a Biomarker in Lupus Nephritis

Evaluation of Uromodulin as a Biomarker of Renal Histological Activity/ Chronicity Indices in Lupus Nephritis

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07763834
Enrollment
90
Registered
2026-08-13
Start date
2026-10-01
Completion date
2030-03-03
Last updated
2026-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SLE, Uromodulin

Brief summary

Evaluation of Uromodulin as a biomarker of renal histological activity/ Chronicity indices in lupus nephritis

Detailed description

Lupus nephritis (LN) is one of the most serious manifestations of systemic lupus erythematosus (SLE) and remains a major cause of chronic kidney disease and end-stage renal disease, particularly among young adults. Early diagnosis and accurate assessment of disease activity are essential to optimize treatment and improve long- term renal outcomes. Renal biopsy remains the gold standard for the diagnosis and classification of lupus nephritis, providing valuable information regarding histopathological activity and chronicity indices that guide therapeutic decisions. However, renal biopsy is an invasive procedure associated with potential complications and cannot be performed repeatedly for disease monitoring. Consequently, there is growing interest in identifying reliable non-invasive biomarkers that accurately reflect renal inflammation and chronic damage. Uromodulin, also known as Tamm-Horsfall protein, is the most abundant protein produced by the epithelial cells of the thick ascending limb of the loop of Henle. Experimental and clinical studies suggest that serum uromodulin is closely related to renal tubular integrity and overall nephron mass. Reduced serum uromodulin levels have been associated with impaired renal function and progressive kidney diseases. Although serum uromodulin has emerged as a promising biomarker in various chronic kidney disorders, its role in lupus nephritis remains insufficiently investigated. Determining whether serum uromodulin correlates with renal histopathological activity and chronicity indices may provide a valuable non-invasive tool for assessing disease severity and monitoring renal involvement.

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* • Group I: 30 patients with different classes of Lupus Nephritis. These cases are biopsy proven LN. Histological diagnosis of LN is according to the revised International Society of Nephrology/ Renal Pathology Society (ISN/RPS) classification and modified National Institute of Health (NIH) activity and chronicity indices (Bajema et al 2018) . * Biopsy-proven lupus nephritis at the time of uromodulin blood sampling. * Group II: 10 patients with active SLE without renal involvement and with SLEDAI score ≥6 * Group III: 10 patients with non-active SLE with SLEDAI score \<6 * Group IV: 30 patients with primary forms of non-lupus Glomerulonephritis * Group V: 10 healthy control subjects * All cases are adults ≥18 years. * Diagnosis of systemic lupus erythematosus according to the 2019 EULAR/ACR Classification Criteria (Ref).

Exclusion criteria

* • .Pregnancy or lactation * AKI secondary to pre renal OR post renal cause (from clinical history and imaging). * End-stage renal disease requiring dialysis * Active infection or sepsis * Active malignancy (either under treatment or within 5 years of successful treatment) * History of renal transplantation * Heart failure with NYHA III and IV * Hhistory of other autoimmune diseases or diabetes mellitus

Design outcomes

Primary

MeasureTime frame
To determine the correlation between serum uromodulin levels and renal histopathological Activity Index (AI) and Chronicity Index (CI) in patients with biopsy-proven lupus nephritis.3years

Contacts

CONTACTMariam Edwar Zaki Bishay
dr.mariamedwar59@gmail.com01288707608
STUDY_DIRECTORMohsen Muhammed Hussein El Kossi

Assiut University

STUDY_DIRECTORAyat Salah Ahmed Barakat

Assiut University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 14, 2026