ClinicalTrials.gg
Not yet recruitingNCT07805109Updated Sep 9, 2026

Subclinical Renal Dysfunction in Rheumatoid Arthritis

An observational study in Rheumatoid Arthritis, Renal Dysfunction and Chronic Kidney Diseases, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
120
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 49 studies in Arthritis, Rheumatoid by Assiut University — 23 open to participants now, 23 under way, none of them phase 3. Arthritis, Rheumatoid · Assiut University.

Planned enrollment
6th of 43
120 · median 80
Started
2026
with 9 others
Observational
43 of 49
22 open now
Primary completion
2027-09
later than 15 of 22 live
Registered
47th of 49
by date

Among the 49 studies in Arthritis, Rheumatoid by Assiut University, this one is the 6th largest by planned enrollment of the 43 observational ones, is one of 10 that started in 2026, is one of 43 observational ones, reaches primary completion later than 15 of the 22 other live ones, and was the 47th registered.

By phase

49 studies; the count open now beside each. This study's row is marked.

Observationalthis study43 · 22 open
No phase5 · 1 open
Phase 41 · 0 open

By the year they started

First in 2016; this study’s year is marked. 10 started in 2026.

What they test

Size and results

Median enrollment 90 across the 6 interventional studies, 80 across the 43 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 49 studies in Arthritis, Rheumatoid by Assiut University, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Rheumatoid Arthritis
  • Renal Dysfunction
  • Chronic Kidney Diseases

Keywords

  • Rheumatoid arthritis
  • Subclinical renal dysfunction
  • eGFR
  • Urine albumin-to-creatinine ratio
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 disease or chronic kidney disease
  • Willingness to provide written

Exclusion criteria

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
  • Patients on maintenance hemodialysis
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
120 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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.

06

What researchers measure

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

  5. 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.

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

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 2302273 ↗
  • 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. PubMed 7748016 ↗
  • 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. PubMed 20396921 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 1, 2026
First posted
Sep 4, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Sep 1, 2027
CompletionEst.
Jun 1, 2028
Last update
Sep 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07805109
Lead sponsor
Assiut University
Responsible party
Nermeen Ebrahim Barsoum (An internal medicine resident physician, Assiut University) — Principal investigator
First posted
Sep 4, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Sep 1, 2027 (estimated)
Completion
Jun 1, 2028 (estimated)
Last update
Sep 9, 2026

Study contacts

Nermeen E barsoum, resident
Contact
Nermin.18313211@med.aun.edu.eg
+201282868576
Essam m abd elaziz, prof
study chair · Internal Medicine Department, Assiut University Hospitals, Assiut, Egypt

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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