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Not yet recruiting NCT07130448

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

Observational Lupus Nephritis (LN) SLE - Systemic Lupus Erythematosus Biomarkers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Lupus Nephritis (LN), SLE - Systemic Lupus Erythematosus, Biomarkers. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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.

Primary outcome measures

  • Association of Albumin/Globulin (A/G) and Platelet/ Albumin (P/A) ratios with the presence of lupus nephritis [Time frame: baseline]
  • Compare the Albumin/Globulin (A/G) and Platelet/Albumin (P/A) ratios between different classes of lupus nephritis [Time frame: baseline]
Secondary outcome measures (2)
  • • 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. [Time frame: baseline]
  • • 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. [Time frame: baseline]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 30009962

Identifiers

NCT: NCT07130448 · Lupus Nephritis biomarkers

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗