An observational study in Systemic Lupus Erythematosus, Systemic Lupus Erythematosus(SLE) and Lupus Nephritis (LN), sponsored by Assiut University. Active, not recruiting at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Assiut University · Observational
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Among 23 studies in Lupus Nephritis by Assiut University — 17 open to participants now, 18 under way, none of them phase 3. Lupus Nephritis · Assiut University.
Among the 23 studies in Lupus Nephritis by Assiut University, this one is the 20th largest by planned enrollment of the 22 observational ones that give a count, is one of 9 that started in 2026, is one of 22 observational ones, reaches primary completion later than 15 of the 17 other live ones, and was the 23rd registered.
342 studies on the registry are indexed under Lupus Nephritis; 136 are open to participants now.
Browse Lupus Nephritis studies →17 of the 23 studies in Lupus Nephritis by Assiut University are open now, in 1 country. Recruiting first, the newest first:
Assiut University
Ages 18–75
Assiut University
Ages 16+
Assiut University
Ages 18+
Assiut University
Ages 18+
Assiut University
Ages 18–60
By country, each count listing its studies:
Of the 89 Lupus Nephritis studies recruiting now, 30 (34%) set no upper age limit and 52 (58%) stop at 75 or younger; 30 take children under 18; 7 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
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23 studies; the count open now beside each. This study's row is marked.
First in 2019; this study’s year is marked. 9 started in 2026.
This study's planned enrollment of 50 is below the median of 100 across 79 observational studies indexed under Lupus Nephritis.
Median enrollment 60 across the 1 interventional studies, 93 across the 22 observational. None of them has completed or been terminated yet.
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Assiut University is the lead sponsor of 5,079 studies on the registry; 2,177 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
7 of the studies in Lupus Nephritis by Assiut University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06564181Assiut UniversityThe Relation Between Serum Zinc and Lupus Nephritis | 2026-12 |
| NCT07505576Assiut UniversityAnti-alpha-actinin Antibodies and Lupus Nephritis Activity | 2027-04-01 |
| NCT06837558Assiut UniversityPredictors of Bone Mineral Density in Lupus Nephritis Activity | 2027-04-01 |
| NCT07780045Assiut UniversitySII and SIRI as Prognostic Biomarkers in Lupus Nephritis | 2027-08-19 |
| NCT07837544Assiut UniversityDiastolic Dysfunction and Inflammatory Biomarkers in Lupus Nephritis | 2027-09-20 |
Add all 7 to your calendar (.ics) → With an account.
Among the 23 studies in Lupus Nephritis by Assiut University, from their registry updates:
This tab as a report to print or save as PDF → With an account.
kidney damage. Monitoring disease activity and predicting treatment response remain challenging because conventional laboratory markers may not always accurately reflect ongoing kidney inflammation.
This prospective observational study aims to evaluate the potential of urinary soluble CD163 (uCD163) as a non-invasive biomarker for predicting renal remission in patients with lupus nephritis. The study will investigate the relationship between urinary CD163 levels, clinical and laboratory parameters, and kidney biopsy findings. Serial urinary CD163 measurements will be performed during a six-month follow-up period to assess their association with changes in disease activity and response to standard immunosuppressive treatment.
The study may help determine whether urinary CD163 can provide additional information for monitoring lupus nephritis and predicting treatment outcomes.
Lupus nephritis (LN) is a major complication of systemic lupus erythematosus (SLE) and an important cause of progressive kidney damage and kidney failure. Assessment of renal disease activity and prediction of treatment response remain challenging because conventional clinical and laboratory markers, including proteinuria, serum creatinine, complement levels, and anti-double-stranded DNA antibodies, may not accurately reflect ongoing inflammation within the kidney.
CD163 is a receptor expressed mainly on macrophages involved in inflammatory processes. Its soluble form can be released into the circulation and urine. Urinary soluble CD163 (uCD163) is a potential non-invasive biomarker of renal inflammation and may provide additional information about disease activity, histopathological findings, and response to immunosuppressive treatment.
This study is designed as a prospective longitudinal observational cohort study conducted at Assiut University Hospitals, involving the Nephrology and Rheumatology Units of the Internal Medicine Department. Adult patients with biopsy-proven active lupus nephritis requiring immunosuppressive treatment will be enrolled and followed for six months.
At baseline, demographic and clinical information will be collected, including age, sex, duration of SLE, relevant medical history, clinical manifestations, current medications, and previous immunosuppressive treatment. Renal biopsy findings will be reviewed to determine the histopathological class according to the International Society of Nephrology/Renal Pathology Society (ISN/RPS) classification, together with the histological activity and chronicity indices.
Urinary soluble CD163 will be measured at baseline and at weeks 4, 8, 12, 16, and 24. Urinary CD163 levels will be assessed in relation to urinary creatinine to account for variations in urine concentration. The laboratory assessment will also include serial measurements of proteinuria, serum creatinine, estimated glomerular filtration rate (eGFR), complement components C3 and C4, and anti-double-stranded DNA antibodies. Additional investigations will include complete blood count, erythrocyte sedimentation rate, and C-reactive protein, as clinically indicated.
Patients will receive standard-of-care immunosuppressive treatment according to their treating physicians' decisions and established clinical practice guidelines. Treatment will not be assigned or modified by the study protocol. The therapeutic approach will include induction therapy aimed at controlling active renal inflammation and achieving remission, followed by maintenance immunosuppression to preserve renal response and reduce the risk of relapse. Treatment details will be documented, including the immunosuppressive agents used, doses, administration schedules, treatment duration, glucocorticoid exposure, dose adjustments, and any changes due to inadequate response, adverse effects, or clinical deterioration. Relevant medications may include glucocorticoids, mycophenolate mofetil, cyclophosphamide, azathioprine, calcineurin inhibitors, and other guideline-based therapies when clinically indicated.
Clinical and laboratory parameters, together with serial urinary CD163 measurements, will be assessed throughout the follow-up period to evaluate changes in renal disease activity and treatment response. The relationship between baseline urinary CD163 levels, early changes during treatment, histopathological findings, and subsequent clinical response will be investigated.
The study will evaluate whether urinary soluble CD163 can serve as a useful non-invasive biomarker for predicting renal remission and monitoring treatment response in patients with lupus nephritis. It will also explore the relationship between urinary CD163 and traditional clinical, laboratory, and histopathological indicators of renal disease activity, with the aim of improving disease monitoring and supporting more accurate assessment of treatment response.
342 studies on the registry are indexed under Lupus Nephritis; 136 are open to participants now.
This study's planned enrollment of 50 is below the median of 100 across 79 observational studies indexed under Lupus Nephritis.
Browse Lupus Nephritis studies →Assiut University is the lead sponsor of 5,079 studies on the registry; 2,177 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 →
The study will be conducted at Assiut University Hospital, Internal Medicine Department, Nephrology unit, and Rheumatology unit,
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.
Exclusion Criteria:
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.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group (I): 30 participants with histologically proven class III, IV, V or any combination of these classes of active LN.
Group (II): 10 patients with active SLE (SLEDAI \> 6) without nephritis confirmed by the absence of albuminuria or microscopic haematuria
Group (III): 10 participants with non-active SLE (SLEDAI score \<2).
Primary (main): Earliest the earliest biochemical level change as a marker of remission/relapse/response to treatment
The predictive performance of urinary soluble CD163 (uCD163), normalized to urinary creatinine, will be evaluated using receiver operating characteristic (ROC) curve analysis to determine its ability to predict complete renal response at 12 months. The area under the ROC curve (AUC) will be calculated, together with sensitivity, specificity, positive predictive value, and negative predictive value, each with 95% confidence intervals. The optimal cutoff value of the uCD163-to-creatinine ratio will be identified using the Youden index. Baseline levels and early changes in uCD163 during follow-up will be assessed as potential predictors of renal response.
Time frame: base line 4 ,8,12,24 and 52 weeks
Correlation of uCD163 level with lupus nephritis renal biopsy class, 24-hour urine protein or urine albumin/creatinine ratio, Serum creatinine, and eGFR.
The association between urinary soluble CD163 (uCD163), normalized to urinary creatinine, and renal disease severity will be assessed by evaluating its correlation with renal biopsy class according to the ISN/RPS classification, 24-hour urinary protein excretion or urine albumin-to-creatinine ratio (ACR), serum creatinine, and estimated glomerular filtration rate (eGFR). Correlations will be analyzed using Pearson's or Spearman's correlation coefficients, as appropriate for the distribution and type of data. Renal biopsy class will be analyzed as a categorical variable. uCD163 and clinical kidney parameters will be assessed at baseline, with serial measurements used where applicable.
Time frame: Baseline and weeks 4, 8, 12, 16,24 and 52.
Predictive value of uCD163 level for renal outcomes: complete renal response (CRR), partial renal response (PRR), or failure of response.
The predictive value of urinary soluble CD163 (uCD163), normalized to urinary creatinine, will be evaluated in relation to renal treatment outcomes in patients with lupus nephritis. Patients will be classified into three response categories: complete renal response (CRR), partial renal response (PRR), or failure to achieve renal response at 12 months , according to predefined clinical and laboratory criteria. Baseline uCD163 levels and early changes during treatment will be analyzed to determine their ability to predict these outcomes. Predictive performance will be assessed using multinomial or binary logistic regression, as appropriate, and receiver operating characteristic (ROC) curve analysis, including area under the curve (AUC), sensitivity, and specificity.
Time frame: Baseline and weeks 4, 8, 12, 16,24 and 52 .
Plan to share: No — These data may contain sensitive patient information. Its not necessarily to share individual-level data publicly.
Started Oct 2026 (actual). Primary completion is estimated for Dec 2027, 14 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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