Diagnostic Performance of Urinary CD163 as a Non-invasive Biomarker for Egyptian Lupus Nephritis Patients Versus Conventional Biomarkers
NCT07930403, Active not recruiting, Assiut University
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Diagnostic Performance of Urinary CD163 as a Non-invasive Biomarker for Egyptian Lupus Nephritis Patients Versus Conventional Biomarkers | ClinicalTrials.gov |
| NCT number | NCT07930403 | ClinicalTrials.gov |
| Status | Active not recruiting | ClinicalTrials.gov |
| Enrollment | 50 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Assiut University | ClinicalTrials.gov |
| Conditions | Systemic Lupus Erythematosus, Systemic Lupus Erythematosus(SLE), Lupus Nephritis (LN) | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Primary (main): Earliest the earliest biochemical level change as a marker of remission/relapse/response to treatment | base line 4 ,8,12,24 and 52 weeks | 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. | ClinicalTrials.gov |
| Secondary | Correlation of uCD163 level with lupus nephritis renal biopsy class, 24-hour urine protein or urine albumin/creatinine ratio, Serum creatinine, and eGFR. | Baseline and weeks 4, 8, 12, 16,24 and 52. | 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. | ClinicalTrials.gov |
| Secondary | Predictive value of uCD163 level for renal outcomes: complete renal response (CRR), partial renal response (PRR), or failure of response. | Baseline and weeks 4, 8, 12, 16,24 and 52 . | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
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Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
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Papers 3
The papers the trial lists on ClinicalTrials.gov.
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
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Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.3.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
Release trials-2026-11-12-0.3.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.