NCT07763821

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
26mo left

Started Sep 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 30, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

August 13, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 9, 2026

Last Update Submit

August 9, 2026

Conditions

Keywords

ribonuclease 1, lupus nephritis

Outcome Measures

Primary Outcomes (1)

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

    Ribonuclease 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

    1 year

Study Arms (2)

lupus nephritis

lupus nephritis serum riboneuclease 1

lupus patients without nephritis

lupus patients without nephritis serum riboneuclease 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Systemic lupus patients from rheumatology outpatient clinic assuit university

You may qualify if:

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

You may not qualify if:

  • Patients less than 18 years old
  • Patients with other autoimmune diseases
  • Active infection and malignancy
  • Pregnancy and lactation
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Kaul A, Gordon C, Crow MK, Touma Z, Urowitz MB, van Vollenhoven R, Ruiz-Irastorza G, Hughes G. Systemic lupus erythematosus. Nat Rev Dis Primers. 2016 Jun 16;2:16039. doi: 10.1038/nrdp.2016.39.

    PMID: 27306639BACKGROUND
  • Singh S, Saxena R. Lupus nephritis. Am J Med Sci. 2009 Jun;337(6):451-60. doi: 10.1097/MAJ.0b013e3181907b3d.

    PMID: 19390431BACKGROUND
  • Pons-Estel GJ, Serrano R, Plasin MA, Espinosa G, Cervera R. Epidemiology and management of refractory lupus nephritis. Autoimmun Rev. 2011 Sep;10(11):655-63. doi: 10.1016/j.autrev.2011.04.032. Epub 2011 May 1.

    PMID: 21565286BACKGROUND
  • Cervera R, Khamashta MA, Font J, Sebastiani GD, Gil A, Lavilla P, Mejia JC, Aydintug AO, Chwalinska-Sadowska H, de Ramon E, Fernandez-Nebro A, Galeazzi M, Valen M, Mathieu A, Houssiau F, Caro N, Alba P, Ramos-Casals M, Ingelmo M, Hughes GR; European Working Party on Systemic Lupus Erythematosus. Morbidity and mortality in systemic lupus erythematosus during a 10-year period: a comparison of early and late manifestations in a cohort of 1,000 patients. Medicine (Baltimore). 2003 Sep;82(5):299-308. doi: 10.1097/01.md.0000091181.93122.55.

    PMID: 14530779BACKGROUND
  • Croca SC, Rodrigues T, Isenberg DA. Assessment of a lupus nephritis cohort over a 30-year period. Rheumatology (Oxford). 2011 Aug;50(8):1424-30. doi: 10.1093/rheumatology/ker101. Epub 2011 Mar 16.

    PMID: 21415024BACKGROUND
  • Bernatsky S, Boivin JF, Joseph L, Manzi S, Ginzler E, Gladman DD, Urowitz M, Fortin PR, Petri M, Barr S, Gordon C, Bae SC, Isenberg D, Zoma A, Aranow C, Dooley MA, Nived O, Sturfelt G, Steinsson K, Alarcon G, Senecal JL, Zummer M, Hanly J, Ensworth S, Pope J, Edworthy S, Rahman A, Sibley J, El-Gabalawy H, McCarthy T, St Pierre Y, Clarke A, Ramsey-Goldman R. Mortality in systemic lupus erythematosus. Arthritis Rheum. 2006 Aug;54(8):2550-7. doi: 10.1002/art.21955.

    PMID: 16868977BACKGROUND

MeSH Terms

Conditions

Lupus Erythematosus, SystemicLupus Nephritis

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesGlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Marwa Ahmad Abdelaziz, Associate Professor

    Marwa.a.galal@aun.edu.eg

    STUDY DIRECTOR
  • Gehan Ibrahim Salem, Professor

    gehan_us@yahoo.com

    STUDY DIRECTOR
  • Ahmed Abdelkhalk Ibrahim, Lecturer

    ahmedhafez_1122@yahoo.com

    STUDY DIRECTOR
  • Amira Mohammad Mansour, Assistant Lecturer

    am9322729@gmail.com

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amira Mohammad Mansour, Assistant lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

August 9, 2026

First Posted

August 13, 2026

Study Start (Estimated)

September 30, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

August 13, 2026

Record last verified: 2026-08