ClinicalTrials.gg
Not yet recruitingNCT07763821Updated Aug 13, 2026

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

An observational study in System Lupus Erythematosus(SLE), sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.

Primary conditionLupus NephritisRegistry: Lupus Erythematosus, SystemicReclassifiedWhy we changed it
Registry
Lupus Erythematosus, Systemic — the first condition term the registry derived for this study.
ClinicalTrials.gg
Lupus Nephritis
Why
  1. The study's title name Lupus Nephritis, a narrower term within Lupus Erythematosus, Systemic.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Assiut University · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
128
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 22 studies in Lupus Nephritis by Assiut University — 17 open to participants now, 17 under way, none of them phase 3. Lupus Nephritis · Assiut University.

Planned enrollment
3rd of 21
128 · median 96
Started
2026
with 7 others
Observational
21 of 22
17 open now
Primary completion
2027-09
later than 12 of 16 live
Registered
19th of 22
by date

Among the 22 studies in Lupus Nephritis by Assiut University, this one is the 3rd largest by planned enrollment of the 21 observational ones that give a count, is one of 8 that started in 2026, is one of 21 observational ones, reaches primary completion later than 12 of the 16 other live ones, and was the 19th registered.

Lupus Nephritis

340 studies on the registry are indexed under Lupus Nephritis; 135 are open to participants now.

Browse Lupus Nephritis studies →

Open to participants now

17 of the 22 studies in Lupus Nephritis by Assiut University are open now, in 1 country. Recruiting first, the newest first:

11 more — sign in →

By country, each count listing its studies:

All 17 open studies →

Where they have run

Who these studies take

Of the 88 Lupus Nephritis studies recruiting now, 30 (34%) set no upper age limit and 51 (58%) stop at 75 or younger; 29 take children under 18; 7 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 22 studies in Lupus Nephritis by Assiut University, or all of them as a file.
02

Study 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 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 .

03

Conditions studied

  • System Lupus Erythematosus(SLE)

Browse trials for

Keywords

  • ribonuclease 1, lupus nephritis
04

In context

Lupus Nephritis Reclassified

340 studies on the registry are indexed under Lupus Nephritis; 135 are open to participants now.

This study's planned enrollment of 128 is above the median of 100 across 77 observational studies indexed under Lupus Nephritis.

Browse Lupus Nephritis studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Compared within Lupus Nephritis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lupus Erythematosus, Systemic. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Systemic lupus patients from rheumatology outpatient clinic assuit university

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Patients less than 18 years old
  2. Patients with other diseases
  3. Active infection and
  4. Pregnancy and lactation
  5. Inability to provide
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

06

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
128 participants (estimated)
Patient registry
No

Groups and cohorts

  • lupus nephritis

    lupus nephritis serum riboneuclease 1

  • lupus patients without nephritis

    lupus patients without nephritis serum riboneuclease 1

07

What researchers measure

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

    Time frame: 1 year

08

Study locations

No study locations are listed for this record.

09

References and documents

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 27306639 ↗
  • Singh S, Saxena R. Lupus nephritis. Am J Med Sci. 2009 Jun;337(6):451-60. doi: 10.1097/MAJ.0b013e3181907b3d. PubMed 19390431 ↗
  • 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. PubMed 21565286 ↗
  • 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. PubMed 14530779 ↗
  • 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. PubMed 21415024 ↗
  • 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. PubMed 16868977 ↗

Individual participant data

Plan to share: Undecided

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 9, 2026
First posted
Aug 13, 2026
StartEst.
Sep 30, 2026
Primary completionEst.
Sep 30, 2027
CompletionEst.
Dec 2028
Last update
Aug 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT07763821
Lead sponsor
Assiut University
Responsible party
Amira Mohammad Abdalmageed Mansour (assistant lecturer, Assiut University) — Principal investigator
First posted
Aug 13, 2026
Start date
Sep 30, 2026 (estimated)
Primary completion
Sep 30, 2027 (estimated)
Completion
Dec 2028 (estimated)
Last update
Aug 13, 2026

Study contacts

Amira Mohammad Mansour, Assistant lecturer
Contact
am9322729@gmail.com
0201099777532
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
Amira Mohammad Mansour, Assistant Lecturer
principal investigator · am9322729@gmail.com

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion