NCT07763834

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
42mo left

Started Oct 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

October 1, 2026

Expected
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2029

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2030

Last Updated

August 13, 2026

Status Verified

August 1, 2026

Enrollment Period

2.8 years

First QC Date

August 9, 2026

Last Update Submit

August 9, 2026

Conditions

UromodulinSLE

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

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

Nephrology and Rheumatology unit, Assiut University Hospital

You may qualify if:

  • 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

You may not qualify if:

  • .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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Devuyst O, Olinger E, Rampoldi L. Uromodulin: from physiology to rare and complex kidney disorders. Nat Rev Nephrol. 2017 Sep;13(9):525-544. doi: 10.1038/nrneph.2017.101. Epub 2017 Aug 7.

    PMID: 28781372RESULT

  • Bedair RN, Amin Ismail MM, Gaber EW, Kader Mahmoud RA, Mowafy MN. Study of the relationship between urinary level of uromodulin, renal involvement and disease activity in patients with systemic lupus erythrematosus. Saudi J Kidney Dis Transpl. 2020 Jan-Feb;31(1):32-43. doi: 10.4103/1319-2442.279959.

    PMID: 32129195RESULT

  • Steubl D, Block M, Herbst V, Nockher WA, Schlumberger W, Satanovskij R, Angermann S, Hasenau AL, Stecher L, Heemann U, Renders L, Scherberich J. Plasma Uromodulin Correlates With Kidney Function and Identifies Early Stages in Chronic Kidney Disease Patients. Medicine (Baltimore). 2016 Mar;95(10):e3011. doi: 10.1097/MD.0000000000003011.

    PMID: 26962815RESULT

  • Lichtnekert J, Anders HJ. Lupus nephritis-related chronic kidney disease. Nat Rev Rheumatol. 2024 Nov;20(11):699-711. doi: 10.1038/s41584-024-01158-w. Epub 2024 Sep 24.

    PMID: 39317803RESULT

  • Parodis I, Tamirou F, Houssiau FA. Prediction of prognosis and renal outcome in lupus nephritis. Lupus Sci Med. 2020 Feb 18;7(1):e000389. doi: 10.1136/lupus-2020-000389. eCollection 2020.

    PMID: 32153796RESULT

  • Anders HJ, Saxena R, Zhao MH, Parodis I, Salmon JE, Mohan C. Lupus nephritis. Nat Rev Dis Primers. 2020 Jan 23;6(1):7. doi: 10.1038/s41572-019-0141-9.

    PMID: 31974366RESULT

Study Officials

  • Mohsen Muhammed Hussein El Kossi

    Assiut University

    STUDY DIRECTOR

  • Ayat Salah Ahmed Barakat

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Mariam Edwar Zaki Bishay

CONTACT

01288707608dr.mariamedwar59@gmail.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
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)

October 1, 2026

Primary Completion (Estimated)

August 2, 2029

Study Completion (Estimated)

March 3, 2030

Last Updated

August 13, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share