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Subclinical Renal Dysfunction in Rheumatoid Arthritis

Assessment of Subclinical Renal Dysfunction in Rheumatoid Arthritis and Its Association With Disease Activity

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07805109
Enrollment
120
Registered
2026-09-04
Start date
2026-09-01
Completion date
2028-06-01
Last updated
2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases, Renal Dysfunction, Rheumatoid Arthritis

Keywords

Rheumatoid arthritis, Subclinical renal dysfunction, eGFR, Urine albumin-to-creatinine ratio

Brief summary

This comparative cross-sectional study aims to determine the prevalence of subclinical renal dysfunction in patients with rheumatoid arthritis and to evaluate its association with disease activity and inflammatory markers compared with age- and sex-matched healthy controls at Assiut University Hospitals.

Detailed description

Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease that may be associated with early renal involvement even before overt chronic kidney disease develops. Subclinical renal dysfunction refers to early impairment of renal function that is not detected by conventional serum creatinine alone. This hospital-based comparative cross-sectional study will include two groups: patients with rheumatoid arthritis diagnosed according to the 2010 ACR/EULAR classification criteria, and age- and sex-matched apparently healthy controls. All participants will undergo clinical assessment, disease activity evaluation using DAS28, laboratory investigations including estimated glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio (UACR), and renal ultrasonography. The study will determine the prevalence of subclinical renal dysfunction and assess its association with disease activity, inflammatory markers, serological markers, disease duration, and treatment-related factors.

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age 18 years or older * For patient group: Diagnosis of rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria * For control group: Age- and sex-matched apparently healthy individuals with no history of autoimmune disease or chronic kidney disease * Willingness to provide written informed consent

Exclusion criteria

* Known chronic kidney disease * Acute kidney injury * Diabetes mellitus * Uncontrolled hypertension * Active urinary tract infection * Pregnancy * History of obstructive uropathy or renal stones * Systemic lupus erythematosus or other connective tissue diseases * Malignancy * Patients on maintenance hemodialysis

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of subclinical renal dysfunctionBaselineProportion of participants with subclinical renal dysfunction, defined as the presence of reduced estimated glomerular filtration rate (eGFR \< 90 mL/min/1.73 m²) and/or elevated urine albumin-to-creatinine ratio (UACR ≥ 30 mg/g) in the absence of previously diagnosed chronic kidney disease.

Secondary

MeasureTime frameDescription
Comparison of eGFR between groupsBaselineMean difference in estimated glomerular filtration rate (eGFR) calculated by the CKD-EPI equation between rheumatoid arthritis patients and healthy controls.
Comparison of UACR between groupsBaselineDifference in urine albumin-to-creatinine ratio (mg/g) between rheumatoid arthritis patients and healthy controls.
Correlation of subclinical renal dysfunction with disease activityBaselineCorrelation coefficient between the presence of subclinical renal dysfunction and DAS28-ESR score (and DAS28-CRP), using Spearman or Pearson correlation as appropriate.
Correlation of subclinical renal dysfunction with inflammatory markersBaselineCorrelation coefficient between the presence of subclinical renal dysfunction and levels of erythrocyte sedimentation rate (ESR, mm/h) and C-reactive protein (CRP, mg/L), using Spearman or Pearson correlation as appropriate..
Independent predictors of subclinical renal dysfunctionBaselineOdds ratios of clinical, inflammatory, serological, disease-related, and treatment-related factors for the presence of subclinical renal dysfunction using multivariable logistic regression analysis.

Contacts

CONTACTNermeen E barsoum, resident
Nermin.18313211@med.aun.edu.eg+201282868576
STUDY_CHAIREssam m abd elaziz, prof

Internal Medicine Department, Assiut University Hospitals, Assiut, Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026