Rheumatoid ArthritisNCT07805109
Subclinical Renal Dysfunction in Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis and Renal Dysfunction, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Renal Dysfunction, Chronic Kidney Diseases
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Jun 2028
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Known chronic kidney disease
- Acute kidney injury
- Diabetes mellitus
- Uncontrolled hypertension
- Active urinary tract infection
- Pregnancy
Show all 10Show fewer
- History of obstructive uropathy or renal stones
- Systemic lupus erythematosus or other connective tissue diseases
- Malignancy
- Patients on maintenance hemodialysis
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment of Subclinical Renal Dysfunction in Rheumatoid Arthritis and Its Association With Disease Activity
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.
Read the 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.
- Keywords
- Rheumatoid arthritis, Subclinical renal dysfunction, eGFR, Urine albumin-to-creatinine ratio
- Medical subject headings
- Arthritis, Rheumatoid, Renal Insufficiency, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (5)
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.
Measured: Baseline
Comparison of UACR between groups
Difference in urine albumin-to-creatinine ratio (mg/g) between rheumatoid arthritis patients and healthy controls.
Measured: Baseline
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.
Measured: Baseline
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..
Measured: Baseline
Independent predictors of subclinical renal dysfunction
Odds ratios of clinical, inflammatory, serological, disease-related, and treatment-related factors for the presence of subclinical renal dysfunction using multivariable logistic regression analysis.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nermeen Ebrahim Barsoum, Assiut University
- Investigators
- Essam m abd elaziz, prof, Study chair, Internal Medicine Department, Assiut University Hospitals, Assiut, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805109
- Sponsor's protocol ID
- RA-Renal-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 2302273Pedersen 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.
PubMed 7748016Daoussis 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.
PubMed 20396921
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Subclinical Renal Dysfunction in Rheumatoid Arthritis and Its Association With Disease Activity
- ClinicalTrials.gov ID
- NCT07805109
- Acronym / sponsor ID
- RA-Renal-Assiut-2026
- Keywords
- Rheumatoid arthritis, Subclinical renal dysfunction, eGFR, Urine albumin-to-creatinine ratio
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- Known chronic kidney disease
- Acute kidney injury
- Diabetes mellitus
- Uncontrolled hypertension
- Active urinary tract infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
Comparison of eGFR between groups
Time frame: Baseline
Comparison of UACR between groups
Time frame: Baseline
Correlation of subclinical renal dysfunction with disease activity
Time frame: Baseline
Correlation of subclinical renal dysfunction with inflammatory markers
Time frame: Baseline
Independent predictors of subclinical renal dysfunction
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 2302273Boers 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.
- Background: PubMed 7748016Pedersen 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.
- Background: PubMed 20396921Daoussis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Essam m abd elaziz, prof study chair
Internal Medicine Department, Assiut University Hospitals, Assiut, Egypt
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Renal Dysfunction, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nermeen E barsoum, resident (+201282868576, Nermin.18313211@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of subclinical renal dysfunction (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07805109, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.