UromodulinNCT07763834
Uromodulin as a Biomarker in Lupus Nephritis
An observational study of Uromodulin and SLE, run by Assiut University.
Trial summary
Evaluation of Uromodulin as a biomarker of renal histological activity/ Chronicity indices in lupus nephritis Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Uromodulin, SLE
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 3 Mar 2030
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Nephrology and Rheumatology unit, Assiut University Hospital
Who may be able to join
- • 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
Show all 19Show fewer
- 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
- Criteria (Ref).Exclusion Criteria:
- • .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
Who cannot join
None listed.
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
Official title: Evaluation of Uromodulin as a Biomarker of Renal Histological Activity/ Chronicity Indices in Lupus Nephritis
Evaluation of Uromodulin as a biomarker of renal histological activity/ Chronicity indices in lupus nephritis
Read the detailed description
Lupus nephritis (LN) is one of the most serious manifestations of systemic lupus erythematosus (SLE) and remains a major cause of chronic kidney disease and end-stage renal disease, particularly among young adults.
Early diagnosis and accurate assessment of disease activity are essential to optimize treatment and improve long- term renal outcomes. Renal biopsy remains the gold standard for the diagnosis and classification of lupus nephritis, providing valuable information regarding histopathological activity and chronicity indices that guide therapeutic decisions. However, renal biopsy is an invasive procedure associated with potential complications and cannot be performed repeatedly for disease monitoring. Consequently, there is growing interest in identifying reliable non-invasive biomarkers that accurately reflect renal inflammation and chronic damage. Uromodulin, also known as Tamm-Horsfall protein, is the most abundant protein produced by the epithelial cells of the thick ascending limb of the loop of Henle. Experimental and clinical studies suggest that serum uromodulin is closely related to renal tubular integrity and overall nephron mass. Reduced serum uromodulin levels have been associated with impaired renal function and progressive kidney diseases. Although serum uromodulin has emerged as a promising biomarker in various chronic kidney disorders, its role in lupus nephritis remains insufficiently investigated. Determining whether serum uromodulin correlates with renal histopathological activity and chronicity indices may provide a valuable non-invasive tool for assessing disease severity and monitoring renal involvement.
- Conditions
- Uromodulin, SLE
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3years
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 start1 Oct 2026 (estimated)
- Primary completion2 Aug 2029 (estimated)
- Study completion3 Mar 2030 (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 UromodulinStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Edwar Zaki Bishay, Assiut University
- Investigators
- Mohsen Muhammed Hussein El Kossi, Study director, Assiut UniversityAyat Salah Ahmed Barakat, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07763834
- Sponsor's protocol ID
- Uromodulin 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
- No
Publications
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.
PubMed 28781372Bedair 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.
PubMed 32129195Steubl 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.
PubMed 26962815Lichtnekert 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.
PubMed 39317803Parodis 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.
PubMed 32153796Anders 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.
PubMed 31974366
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
- Evaluation of Uromodulin as a Biomarker of Renal Histological Activity/ Chronicity Indices in Lupus Nephritis
- ClinicalTrials.gov ID
- NCT07763834
- Acronym / sponsor ID
- Uromodulin in SLE
- Conditions
- Uromodulin, SLE
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 2 Aug 2029 (estimated)
- Study completion
- 3 Mar 2030 (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.
Evaluation of Uromodulin as a biomarker of renal histological activity/ Chronicity indices in lupus nephritis
Detailed description
Lupus nephritis (LN) is one of the most serious manifestations of systemic lupus erythematosus (SLE) and remains a major cause of chronic kidney disease and end-stage renal disease, particularly among young adults.
Early diagnosis and accurate assessment of disease activity are essential to optimize treatment and improve long- term renal outcomes. Renal biopsy remains the gold standard for the diagnosis and classification of lupus nephritis, providing valuable information regarding histopathological activity and chronicity indices that guide therapeutic decisions. However, renal biopsy is an invasive procedure associated with potential complications and cannot be performed repeatedly for disease monitoring. Consequently, there is growing interest in identifying reliable non-invasive biomarkers that accurately reflect renal inflammation and chronic damage. Uromodulin, also known as Tamm-Horsfall protein, is the most abundant protein produced by the epithelial cells of the thick ascending limb of the loop of Henle. Experimental and clinical studies suggest that serum uromodulin is closely related to renal tubular integrity and overall nephron mass. Reduced serum uromodulin levels have been associated with impaired renal function and progressive kidney diseases. Although serum uromodulin has emerged as a promising biomarker in various chronic kidney disorders, its role in lupus nephritis remains insufficiently investigated. Determining whether serum uromodulin correlates with renal histopathological activity and chronicity indices may provide a valuable non-invasive tool for assessing disease severity and monitoring renal involvement.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Nephrology and Rheumatology unit, Assiut University Hospital
Key inclusion criteria (19 listed)
- • 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
Key exclusion criteria (0 listed)
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
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.
Time frame: 3years
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.
- Results publication: PubMed 28781372Devuyst 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.
- Results publication: PubMed 32129195Bedair 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.
- Results publication: PubMed 26962815Steubl 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.
- Results publication: PubMed 39317803Lichtnekert 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.
- Results publication: PubMed 32153796Parodis 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.
- Results publication: PubMed 31974366Anders 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.
- Individual participant dataSharing planned: No
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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.
Mohsen Muhammed Hussein El Kossi study director
Assiut University
Ayat Salah Ahmed Barakat study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Uromodulin and 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 19 inclusion and 0 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 Mariam Edwar Zaki Bishay (01288707608, dr.mariamedwar59@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 3years). 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 NCT07763834, 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.