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NCT Number: NCT07130448

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: baseline

    unit of measurments : ratios (no units )

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

    Time frame: baseline

    unite of measurments : ratios (no units )

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Ghada Hassan Ahmed

CONTACT

[email protected]

+201005790410

Mina Maged William

CONTACT

[email protected]

+201020910834

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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