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Subclinical Renal Dysfunction in Rheumatoid Arthritis

ConditionsRheumatoid ArthritisRenal DysfunctionChronic Kidney Diseases
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Known chronic kidney disease

Acute kidney injury

Diabetes mellitus

Uncontrolled hypertension

Trial population

Adult patients with rheumatoid arthritis attending the Rheumatology outpatient clinic and inpatient wards at Assiut University Hospitals, and age- and sex-matched healthy controls.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 2 trial groups
Group A: Rheumatoid arthritis patients (n=80)
Group B: Healthy controls (n=40)

Trial outcomes

Primary outcomes

1

Prevalence of subclinical renal dysfunction

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.

Time frame
Baseline

Secondary outcomes

1

Comparison of eGFR between groups

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

Time frame
Baseline
2

Comparison of UACR between groups

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

Time frame
Baseline
3

Correlation of subclinical renal dysfunction with disease activity

Correlation coefficient between the presence of subclinical renal dysfunction and DAS28-ESR score (and DAS28-CRP), using Spearman or Pearson correlation as appropriate.

Time frame
Baseline
4

Correlation of subclinical renal dysfunction with inflammatory markers

Correlation 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..

Time frame
Baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: