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Clinical Utility of Serum Ribonuclease 1(RNASE1) as a Biomarker of Lupus Nephritis.

Clinical Utility of Serum Ribonuclease 1(RNASE1) as a Biomarker of Lupus Nephritis.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07763821
Enrollment
128
Registered
2026-08-13
Start date
2026-09-30
Completion date
2028-12-01
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

System Lupus Erythematosus(SLE)

Keywords

ribonuclease 1, lupus nephritis

Brief summary

This study will identify the level of serum Riboneuclease 1 in systemic lupus patients and compare between its level in lupus nephritis and non nephritis.

Detailed description

Systemic lupus erythematosus (SLE) is a chronic, multisystem autoimmune disease that has a heterogeneous clinical presentation, ultimately leading to damage of multiple organs. Lupus nephritis (LN) constitutes one of the most severe organ manifestations of SLE. Understanding of the genetic and pathogenetic basis of LN has improved substantially over the past few decades. However, despite this increased knowledge and improved treatment options LN remains a substantial cause of morbidity and death among patients with SLE . Renal biopsy remains the gold standard for diagnosing LN and evaluating histological activity and prognostication . However, its invasive nature limits repeated assessment and longitudinal monitoring. In practice, serological markers such as (C3and C4), (dsDNA) antibodies, and routine laboratory parameters including proteinuria and serum creatinine are commonly used to evaluate disease activity . These markers have limited sensitivity and specificity, and their fluctuations often fail to fully reflect parallel histological changes in the kidney. Therefore, the identification of reliable and non-invasive biomarkers that better capture both systemic immune activation and renal involvement remain an important unmet need. Ribonuclease 1 (RNASE1) is a secreted endoribonuclease predominantly produced by endothelial cells and plays an essential role in the degradation of extracellular RNA . These are suggested to promote endothelial activation, immune cell infiltration and activation, so promote inflammatory responses . Since that endothelial dysfunction & inflammatory signalling are central mechanism in LN pathogenesis, dysregulation of RNASE1 mediated extracellular RNA clearance may contribute to renal inflammatory injury, suggesting RNASE1 as a potential biomarker in LN .

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

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

Inclusion criteria

1. Adult patients (≥18 years old) with non lupus nephritis SLE diagnosed according to the 2019 EULAR/ACR Classification Criteria for Systemic Lupus Erythematosus . 2. Adult patients (≥18 years old) with Lupus Nephritis classified according to the 2018 ISN/RPS classification criteria.

Exclusion criteria

1. Patients less than 18 years old 2. Patients with other autoimmune diseases 3. Active infection and malignancy 4. Pregnancy and lactation 5. Inability to provide informed consent

Design outcomes

Primary

MeasureTime frameDescription
Clinical Utility of Serum Ribonuclease 1(RNASE1) as a Biomarker of Lupus Nephritis.1 yearRibonuclease 1 (RNASE1) is a secreted endoribonuclease predominantly produced by endothelial cells and plays an essential role in the degradation of extracellular RNA \[11\]. These are suggested to promote endothelial activation, immune cell infiltration and activation, so promote inflammatory responses \[12-15\]. Since that endothelial dysfunction \& inflammatory signalling are central mechanism in LN pathogenesis, dysregulation of RNASE1 mediated extracellular RNA clearance may contribute to renal inflammatory injury, suggesting RNASE1 as a potential biomarker in LN

Contacts

CONTACTAmira Mohammad Mansour, Assistant lecturer
am9322729@gmail.com0201099777532
STUDY_DIRECTORMarwa Ahmad Abdelaziz, Associate Professor

Marwa.a.galal@aun.edu.eg

STUDY_DIRECTORGehan Ibrahim Salem, Professor

gehan_us@yahoo.com

STUDY_DIRECTORAhmed Abdelkhalk Ibrahim, Lecturer

ahmedhafez_1122@yahoo.com

PRINCIPAL_INVESTIGATORAmira Mohammad Mansour, Assistant Lecturer

am9322729@gmail.com

Outcome results

None listed

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