System Lupus Erythematosus(SLE)NCT07763821
Clinical Utility of Serum Ribonuclease 1(RNASE1) as a Biomarker of Lupus Nephritis.
An observational study of System Lupus Erythematosus(SLE), run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- System Lupus Erythematosus(SLE)
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Systemic lupus patients from rheumatology outpatient clinic assuit university
Who may be able to join
- 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.
Who cannot join
- Patients less than 18 years old
- Patients with other autoimmune diseases
- Active infection and malignancy
- Pregnancy and lactation
- Inability to provide informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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 .
- Conditions
- System Lupus Erythematosus(SLE)
- Keywords
- ribonuclease 1, lupus nephritis
- Medical subject headings
- Lupus Erythematosus, Systemic, Lupus Nephritis
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 |
|---|---|---|
| lupus nephritis | lupus nephritis serum riboneuclease 1 | |
| lupus patients without nephritis | lupus patients without nephritis serum riboneuclease 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for System Lupus Erythematosus(SLE)Studies of the same condition, open and under way.
- More trials run by Assiut 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mohammad Abdalmageed Mansour, Assiut University
- Investigators
- Marwa Ahmad Abdelaziz, Associate Professor, Study director, Marwa.a.galal@aun.edu.egGehan Ibrahim Salem, Professor, Study director, gehan_us@yahoo.comAhmed Abdelkhalk Ibrahim, Lecturer, Study director, ahmedhafez_1122@yahoo.comAmira Mohammad Mansour, Assistant Lecturer, Principal investigator, am9322729@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763821
- Sponsor's protocol ID
- Serum Ribonuclease 1 in SLE
- Status last verified
- Aug 2026
- First submitted
- 9 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27306639Singh S, Saxena R. Lupus nephritis. Am J Med Sci. 2009 Jun;337(6):451-60. doi: 10.1097/MAJ.0b013e3181907b3d.
PubMed 19390431Pons-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.
PubMed 21565286Cervera 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.
PubMed 14530779Croca 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.
PubMed 21415024Bernatsky 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.
PubMed 16868977
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of Serum Ribonuclease 1(RNASE1) as a Biomarker of Lupus Nephritis.
- ClinicalTrials.gov ID
- NCT07763821
- Acronym / sponsor ID
- Serum Ribonuclease 1 in SLE
- Conditions
- System Lupus Erythematosus(SLE)
- Keywords
- ribonuclease 1, lupus nephritis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 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.
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 .
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lupus nephritis | – | –lupus nephritis serum riboneuclease 1 |
| lupus patients without nephritis | – | –lupus patients without nephritis serum riboneuclease 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Systemic lupus patients from rheumatology outpatient clinic assuit university
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- Patients less than 18 years old
- Patients with other autoimmune diseases
- Active infection and malignancy
- Pregnancy and lactation
- Inability to provide informed consent
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
Clinical Utility of Serum Ribonuclease 1(RNASE1) as a Biomarker of Lupus Nephritis.
Time frame: 1 year
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Background: PubMed 27306639Kaul 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.
- Background: PubMed 19390431Singh S, Saxena R. Lupus nephritis. Am J Med Sci. 2009 Jun;337(6):451-60. doi: 10.1097/MAJ.0b013e3181907b3d.
- Background: PubMed 21565286Pons-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.
- Background: PubMed 14530779Cervera 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.
- Background: PubMed 21415024Croca 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.
- Background: PubMed 16868977Bernatsky 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.
- Individual participant dataSharing planned: Undecided
Related trials for System Lupus Erythematosus(SLE)
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingPhase 1
To Evaluate the Effects of Cevostamab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
Lupus Erythematosus, Systemic
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.
Marwa Ahmad Abdelaziz, Associate Professor study director
Marwa.a.galal@aun.edu.eg
Gehan Ibrahim Salem, Professor study director
gehan_us@yahoo.com
Ahmed Abdelkhalk Ibrahim, Lecturer study director
ahmedhafez_1122@yahoo.com
Questions about this trial
What is this clinical trial studying?
An observational study of System Lupus Erythematosus(SLE), run by Assiut University.
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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amira Mohammad Mansour, Assistant lecturer (0201099777532, am9322729@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Utility of Serum Ribonuclease 1(RNASE1) as a Biomarker of Lupus Nephritis. (time frame: 1 year). 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 NCT07763821, which also lists 6 linked publications.
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 13 Aug 2026.