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Lupus Nephritis (LN)NCT07130448

The Relation of Albumin/Globulin Ratio and Platelet/Albumin Ratio to Lupus Nephritis

An observational study of Lupus Nephritis (LN) and SLE - Systemic Lupus Erythematosus, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Albumin/globulin ratio and platelet/albumin ratio as a predictive non-invasive biomarker for lupus nephritis (LN) presence and severity Read more about this study

Who is it for?
Ages 18 years and older
How many people
120 participants
Where
No sites listed yet
Study dates
Sep 2025to Oct 2026
How long will I take part?
1 Year
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
  • No healthy volunteers
  • Adult, Older adult

Study population: Aged ≥18 years. * SLE patients fulfilling the SLE International Collaborating Clinics (SLICC) - ----classification criteria and matched controls. * Patients cooperative and can answer questions. * Patients who are able and willing to give written informed consent.

Who may be able to join

  • Patients aged 18 years or older diagnosed as SLE according to 2019 ACR/EULAR classification criteria and with lupus nephritis (LN) according to the ACR criteria.
  • Patients with available baseline laboratory investigations and renal biopsy.

Who cannot join

  • Patients with chronic liver disease, hematological disorders, or malignancies affecting albumin/globulin ratio or platelet counts.
  • Patients on nephrotoxic medications not related to SLE management.
  • Recent infections or acute inflammatory conditions.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Mina Maged William contact

+201020910834

Mena.17289637@med.aun.edu.eg

Ghada Hassan Ahmed contact

+201005790410

gh_hassan@aun.edu.eg

About this study

Official title: The Relation of Albumin/Globulin Ratio and Platelet/Albumin Ratio to Lupus Nephritis in Upper Egypt ( Single Center Study)

Albumin/globulin ratio and platelet/albumin ratio as a predictive non-invasive biomarker for lupus nephritis (LN) presence and severity

Read the detailed description

Lupus nephritis (LN) is one of the most frequent and severe manifestations of systemic lupus erythematosus (SLE) and serves as a major predictor of poor prognosis . Delayed diagnosis significantly increases the risk of renal insufficiency and progression to end-stage renal disease (ESRD) . Conventional laboratory markers-such as proteinuria, urine protein-to-creatinine ratio, creatinine clearance, anti-double-stranded DNA (anti-dsDNA) antibodies, and complement levels-are commonly used to assess LN . However, these markers often lack sufficient sensitivity and specificity for early diagnosis and disease monitoring .This limitation has prompted interest in identifying reliable, non-invasive, and cost-effective biomarkers for LN. The albumin/globulin (A/G) ratio is one such biomarker, reflecting systemic inflammation and immune dysregulation. In SLE, inflammation or proteinuria often leads to hypoalbuminemia, while increased immunoglobulin production elevates globulin levels, reducing the A/G ratio. Lower ratios have been associated with increased disease activity and organ damage .

Another emerging marker is the platelet/albumin (P/A) ratio, which integrates inflammatory status with nutritional and renal function indicators. It has demonstrated prognostic value in diabetes mellitus ,cardiovascular, hepatic, and autoimmune conditions .Despite their promise, these biomarkers have not been adequately studied in Egyptian LN patients. Given that regional and demographic variations may influence disease expression, evaluating these ratios in Upper Egypt may provide clinically relevant insights and inform local disease management strategies.

Medical subject headings
Lupus Nephritis, Lupus Erythematosus, Systemic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Association of Albumin/Globulin (A/G) and Platelet/ Albumin (P/A) ratios with the presence of lupus nephritis

    unit of measurments : ratios (no units )

    Measured: baseline

  2. Compare the Albumin/Globulin (A/G) and Platelet/Albumin (P/A) ratios between different classes of lupus nephritis

    unite of measurments : ratios (no units )

    Measured: baseline

Secondary outcomes (2)

  1. • Correlation of A/G and P/A ratios with lupus nephritis class, 24-hour urine protein or urine protein/creatinine ratio, Serum creatinine and eGFR.

    Measured: baseline

  2. • Predictive value of A/G and P/A ratios for renal involvement: Using logistic regression or ROC curve analysis to assess whether these ratios can predict the presence of nephritis.

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2025
  2. Study startSep 2025 (estimated)
  3. Primary completionSep 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

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
Cohort
Time perspective
Cross-sectional
Enrolment
120 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT07130448
Sponsor's protocol ID
Lupus Nephritis biomarkers
Status last verified
Aug 2025
First submitted
10 Aug 2025
Last updated
19 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Leng L, Shen J, Li L, Li J, Li X, Liu D. Nonlinear association between platelet to albumin ratio and disease activity in patients with early rheumatoid arthritis. Sci Rep. 2024 Nov 7;14(1):27112. doi: 10.1038/s41598-024-78582-1.

    PubMed 39511276

  • Cao SL, Zhang GQ, Li J, Bao L, Lan XM, Jin QP, Luo HY, E J, Li B, Ma D, Bao X, Zheng YL. Platelet-to-albumin ratio is a potential biomarker for predicting diabetic nephropathy in patients with type 2 diabetes. Biomark Med. 2023 Oct;17(20):841-848. doi: 10.2217/bmm-2023-0527. Epub 2024 Jan 5.

    PubMed 38180339

  • Hao P, Feng S, Suo M, Wang S, Wu X. Platelet to albumin ratio: A risk factor related to prognosis in patients with non-ST-segment elevation acute coronary syndrome undergoing percutaneous coronary intervention. Int J Cardiol. 2024 Jan 15;395:131588. doi: 10.1016/j.ijcard.2023.131588. Epub 2023 Nov 19.

    PubMed 37989451

  • Liu M, Li X, Huang Y, Huang Z, Huang Q. Albumin to globulin ratio (AGR) in systemic lupus erythematosus: correlation with disease activity. J Int Med Res. 2024 Apr;52(4):3000605241244761. doi: 10.1177/03000605241244761.

    PubMed 38661083

  • Mok CC. Biomarkers for lupus nephritis: a critical appraisal. J Biomed Biotechnol. 2010;2010:638413. doi: 10.1155/2010/638413. Epub 2010 Apr 19.

    PubMed 20414362

  • Faurschou M, Starklint H, Halberg P, Jacobsen S. Prognostic factors in lupus nephritis: diagnostic and therapeutic delay increases the risk of terminal renal failure. J Rheumatol. 2006 Aug;33(8):1563-9.

    PubMed 16881113

  • Dumestre-Perard C, Clavarino G, Colliard S, Cesbron JY, Thielens NM. Antibodies targeting circulating protective molecules in lupus nephritis: Interest as serological biomarkers. Autoimmun Rev. 2018 Sep;17(9):890-899. doi: 10.1016/j.autrev.2018.03.013. Epub 2018 Jul 29.

    PubMed 30009962

Questions about this trial

What is this clinical trial studying?

An observational study of Lupus Nephritis (LN) and SLE - Systemic Lupus Erythematosus, 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 2 inclusion and 3 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 19 Aug 2025. 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 Mina Maged William (+201020910834, Mena.17289637@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Association of Albumin/Globulin (A/G) and Platelet/ Albumin (P/A) ratios with the presence of lupus nephritis (time frame: baseline). The study lists 2 primary outcomes in all. 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 NCT07130448, which also lists 7 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 19 Aug 2025.

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