NCT07130448

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Sep 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress63%
Sep 2025Oct 2026

First Submitted

Initial submission to the registry

August 10, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

August 10, 2025

Last Update Submit

August 15, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

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

    unit of measurments : ratios (no units )

    baseline

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

    unite of measurments : ratios (no units )

    baseline

Secondary Outcomes (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.

    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.

    baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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: 39511276BACKGROUND
  • 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: 38180339BACKGROUND
  • 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: 37989451BACKGROUND
  • 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: 38661083BACKGROUND
  • 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: 20414362BACKGROUND
  • 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: 16881113BACKGROUND
  • 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: 30009962BACKGROUND

MeSH Terms

Conditions

Lupus NephritisLupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Ghada Hassan Ahmed

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 10, 2025

First Posted

August 19, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

August 19, 2025

Record last verified: 2025-08