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NCT Number: NCT07805109

Subclinical Renal Dysfunction in Rheumatoid Arthritis

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Chronic Disease Chronic Kidney Diseases Connective Tissue Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Immune System Diseases Joint Diseases Kidney Diseases Male Urogenital Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Dysfunction Renal Insufficiency Renal Insufficiency, Chronic Rheumatic Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Prevalence of subclinical renal dysfunction

    Time frame: Baseline

    Proportion 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 outcomes

  1. Comparison of eGFR between groups

    Time frame: Baseline

    Mean difference in estimated glomerular filtration rate (eGFR) calculated by the CKD-EPI equation between rheumatoid arthritis patients and healthy controls.

  2. Comparison of UACR between groups

    Time frame: Baseline

    Difference in urine albumin-to-creatinine ratio (mg/g) between rheumatoid arthritis patients and healthy controls.

  3. Association with disease activity

    Time frame: Baseline

    Association between subclinical renal dysfunction and DAS28-ESR (and DAS28-CRP) scores.

  4. Association with inflammatory markers

    Time frame: Baseline

    Association between subclinical renal dysfunction and levels of ESR and CRP.

  5. Independent predictors of subclinical renal dysfunction

    Time frame: Baseline

    Clinical, inflammatory, serological, disease-related, and treatment-related factors independently associated with subclinical renal dysfunction using multivariable regression analysis.

Study contacts

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

Nermeen E barsoum, resident

CONTACT

[email protected]

+201282868576

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 4, 2026
Registry last updated
Sep 4, 2026

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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