NCT07805109

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.

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
20mo left

Started Sep 2026

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Sep 2026Jun 2028

First Submitted

Initial submission to the registry

September 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

September 9, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 1, 2026

Last Update Submit

September 4, 2026

Conditions

Keywords

Rheumatoid arthritisSubclinical renal dysfunctioneGFRUrine albumin-to-creatinine ratio

Outcome Measures

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.

    Baseline

Secondary Outcomes (5)

  • Comparison of eGFR between groups

    Baseline

  • Comparison of UACR between groups

    Baseline

  • Correlation of subclinical renal dysfunction with disease activity

    Baseline

  • Correlation of subclinical renal dysfunction with inflammatory markers

    Baseline

  • Independent predictors of subclinical renal dysfunction

    Baseline

Study Arms (2)

Rheumatoid arthritis patients (n=80)

Adult patients diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria attending the Rheumatology outpatient clinic and inpatient wards at Assiut University Hospitals.

Healthy controls (n=40)

Age- and sex-matched apparently healthy individuals with no history of autoimmune disease or chronic kidney disease.

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Boers M, Dijkmans BA, Breedveld FC, Camps JA, Chang PC, van Brummelen P, Pauwels EK, Cats A. Subclinical renal dysfunction in rheumatoid arthritis. Arthritis Rheum. 1990 Jan;33(1):95-101. doi: 10.1002/art.1780330113.

    PMID: 2302273BACKGROUND
  • Pedersen LM, Nordin H, Svensson B, Bliddal H. Microalbuminuria in patients with rheumatoid arthritis. Ann Rheum Dis. 1995 Mar;54(3):189-92. doi: 10.1136/ard.54.3.189.

    PMID: 7748016BACKGROUND
  • Daoussis D, Panoulas VF, John H, Toms TE, Antonopoulos I, Treharne G, Nightingale P, Douglas KM, Kitas GD. Microalbuminuria in rheumatoid arthritis in the post penicillamine/gold era: association with hypertension, but not therapy or inflammation. Clin Rheumatol. 2011 Apr;30(4):477-84. doi: 10.1007/s10067-010-1446-y. Epub 2010 Apr 16.

    PMID: 20396921BACKGROUND

MeSH Terms

Conditions

Arthritis, RheumatoidRenal InsufficiencyRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Essam m abd elaziz, prof

    Internal Medicine Department, Assiut University Hospitals, Assiut, Egypt

    STUDY CHAIR

Central Study Contacts

Nermeen E barsoum, resident

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
An internal medicine resident physician

Study Record Dates

First Submitted

September 1, 2026

First Posted

September 4, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

September 9, 2026

Record last verified: 2026-09