Rheumatoid ArthritisNCT06227442
Renal Resistive Index as a Predictor of Renal Involvement in Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Assiut University.
Trial summary
Evaluation of resistive index on the renal artery as early predictor factor of renal affection in patients with rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- KDIGO criteria of 2010
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Base on determining the main outcome variable, the estimated minimum required sample size is 144 cases (48 case in each group) The sample size was calculated using G*power software 3.1.9.7 based on following assumptions: Mean serum creatinine level in RA patients without renal affection compared to mean serum creatinine level RA patients with renal affection and control group. The Effect size is estimated to be 0.3. Main statistical test is one way ANOVA ,Alpha=0.05, power=90
Who may be able to join
- Patients of rheumatoid arthritis è renal affection
- Patients of rheumatoid arthritis without renal affection
- Patients of rheumatoid arthritis on drugs (NSAIDs, DMARDS, methotrexate..).
Who cannot join
- Diabetic and hypertensive patients, patients with hepatitis B, C viruses or liver cell failure, patients with acute kidney injury, patients with another autoimmune disease as (SLE, sjogren disease, multiple sclerosis, patients with malignancy, patients on another drugs otherwise rheumatoid arthritis drugs).
About this study
Official title: Predictor of Renal Involvement in Rheumatoid Arthritis:Value of Renal Resistive Index
Evaluation of resistive index on the renal artery as early predictor factor of renal affection in patients with rheumatoid arthritis.
Read the detailed description
Rheumatoid arthritis (RA) is a chronic autoimmune disorder characterized by synovial hyperplasia and inflammation, progressive joint destruction, and significant disability (1). It can occur at any age, but it predominantly affects women, with a peak onset between the ages of 40 and 60. RA etiology is not yet clear, Recent studies have shown that its mechanism is closely related to genetics, environment, and immune response. Genes such as MHC and HLA-DR4 are involved in the occurrence of RA. (2) Renal complications in RA can range from mild abnormalities in kidney function to more severe conditions, such as glomerulonephritis and renal amyloidosis. Understanding these renal complications is crucial for healthcare providers to ensure comprehensive care for RA patients. (3.4) Vasculitis is an uncommon complication of RA (in approximately 2 to 5% of patients), males with RA are more likely (2 to 4 times more likely) than females with RA to develop RV. Rheumatoid vasculitis most often occur in people with at least 10 years of severe disease. Fortunately, recent reports have noted declines in the prevalence of RV ( 5.6). So The renal arterial resistive index (RI)which is a sonographic index of intrarenal arteries defined as (peak systolic velocity - end-diastolic velocity) / peak systolic velocity. The normal range is 0.50-0.70. Elevated values are associated with poorer prognosis in various renal disorders .
- Conditions
- Rheumatoid Arthritis
- Being tested
- KDIGO criteria of 2010
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KDIGO criteria of 2010Diagnostic test
They are guidelines for the diagnosis, evaluation, and management of chronic kidney disease (CKD). They cover the classification of CKD stages based on glomerular filtration rate and albuminuria, criteria for diagnosing acute kidney injury, and recommendations for managing CKD-related complications.
| Study group | Role | What they receive |
|---|---|---|
| Group A | will include 48 RA patients without renal affection. Receives: Diagnostic Test: KDIGO criteria of 2010 | |
| Group B | will include 48 RA patients with renal affection. Receives: Diagnostic Test: KDIGO criteria of 2010 | |
| Group C | will include 48 healthy control. Receives: Diagnostic Test: KDIGO criteria of 2010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating predictive value of renal resistive index in detection of rheumatoid arthritis.
Assesses the predictive utility of renal resistive index in detecting rheumatoid arthritis. Delve into the exploration of whether renal resistive index serves as a reliable marker, offering valuable insights into the potential diagnostic relevance for rheumatoid arthritis.
Measured: baseline
Secondary outcomes (1)
Identify the risk factor for renal complication in RA patients
Explore the factors contributing to renal complications in rheumatoid arthritis (RA) patients with a focus on identifying key risk factors. Uncover insights that enhance our understanding of the complex relationship between RA and renal involvement, ultimately aiding in targeted prevention and management strategies.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Noman Mohamed AbdElaziz, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227442
- Sponsor's protocol ID
- PORIIRA
- Status last verified
- Jan 2024
- First submitted
- 18 Jan 2024
- Last updated
- 26 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li XF, Sun YY, Bao J, Chen X, Li YH, Yang Y, Zhang L, Huang C, Wu BM, Meng XM, Li J. Functional role of PPAR-gamma on the proliferation and migration of fibroblast-like synoviocytes in rheumatoid arthritis. Sci Rep. 2017 Oct 4;7(1):12671. doi: 10.1038/s41598-017-12570-6.
PubMed 28978936Jung JY, Kim YB, Kim JW, Suh CH, Kim HA. Biologic therapy for amyloid A amyloidosis secondary to rheumatoid arthritis treated with interleukin 6 therapy: Case report and review of literature. Medicine (Baltimore). 2021 Aug 13;100(32):e26843. doi: 10.1097/MD.0000000000026843.
PubMed 34397890Oweis AO, Alawneh KM, Alshelleh SA, Alnaimat F, Alawneh D, Zahran DJ. Renal dysfunction among rheumatoid arthritis patients: A retrospective cohort study. Ann Med Surg (Lond). 2020 Nov 4;60:280-284. doi: 10.1016/j.amsu.2020.11.011. eCollection 2020 Dec.
PubMed 33204418Alamanos Y, Voulgari PV, Drosos AA. Incidence and prevalence of rheumatoid arthritis, based on the 1987 American College of Rheumatology criteria: a systematic review. Semin Arthritis Rheum. 2006 Dec;36(3):182-8. doi: 10.1016/j.semarthrit.2006.08.006. Epub 2006 Oct 11.
PubMed 17045630Vollertsen RS, Conn DL. Vasculitis associated with rheumatoid arthritis. Rheum Dis Clin North Am. 1990 May;16(2):445-61.
PubMed 2189161
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictor of Renal Involvement in Rheumatoid Arthritis:Value of Renal Resistive Index
- ClinicalTrials.gov ID
- NCT06227442
- Acronym / sponsor ID
- PORIIRA
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 26 Jan 2024 (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.
Evaluation of resistive index on the renal artery as early predictor factor of renal affection in patients with rheumatoid arthritis.
Detailed description
Rheumatoid arthritis (RA) is a chronic autoimmune disorder characterized by synovial hyperplasia and inflammation, progressive joint destruction, and significant disability (1). It can occur at any age, but it predominantly affects women, with a peak onset between the ages of 40 and 60. RA etiology is not yet clear, Recent studies have shown that its mechanism is closely related to genetics, environment, and immune response. Genes such as MHC and HLA-DR4 are involved in the occurrence of RA. (2) Renal complications in RA can range from mild abnormalities in kidney function to more severe conditions, such as glomerulonephritis and renal amyloidosis. Understanding these renal complications is crucial for healthcare providers to ensure comprehensive care for RA patients. (3.4) Vasculitis is an uncommon complication of RA (in approximately 2 to 5% of patients), males with RA are more likely (2 to 4 times more likely) than females with RA to develop RV. Rheumatoid vasculitis most often occur in people with at least 10 years of severe disease. Fortunately, recent reports have noted declines in the prevalence of RV ( 5.6). So The renal arterial resistive index (RI)which is a sonographic index of intrarenal arteries defined as (peak systolic velocity - end-diastolic velocity) / peak systolic velocity. The normal range is 0.50-0.70. Elevated values are associated with poorer prognosis in various renal disorders .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Diagnostic Test: KDIGO criteria of 2010will include 48 RA patients without renal affection. |
| Group B | – | Diagnostic Test: KDIGO criteria of 2010will include 48 RA patients with renal affection. |
| Group C | – | Diagnostic Test: KDIGO criteria of 2010will include 48 healthy control. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Base on determining the main outcome variable, the estimated minimum required sample size is 144 cases (48 case in each group) The sample size was calculated using G*power software 3.1.9.7 based on following assumptions: Mean serum creatinine level in RA patients without renal affection compared to mean serum creatinine level RA patients with renal affection and control group. The Effect size is estimated to be 0.3. Main statistical test is one way ANOVA ,Alpha=0.05, power=90
Key inclusion criteria (3 listed)
- Patients of rheumatoid arthritis è renal affection
- Patients of rheumatoid arthritis without renal affection
- Patients of rheumatoid arthritis on drugs (NSAIDs, DMARDS, methotrexate..).
Key exclusion criteria (1 listed)
- Diabetic and hypertensive patients, patients with hepatitis B, C viruses or liver cell failure, patients with acute kidney injury, patients with another autoimmune disease as (SLE, sjogren disease, multiple sclerosis, patients with malignancy, patients on another drugs otherwise rheumatoid arthritis drugs).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KDIGO criteria of 2010They are guidelines for the diagnosis, evaluation, and management of chronic kidney disease (CKD). They cover the classification of CKD stages based on glomerular filtration rate and albuminuria, criteria for diagnosing acute kidney injury, and recommendations for managing CKD-related complications. | Diagnostic test | Group A, Group B, Group C |
Primary outcome
Evaluating predictive value of renal resistive index in detection of rheumatoid arthritis.
Time frame: baseline
Assesses the predictive utility of renal resistive index in detecting rheumatoid arthritis. Delve into the exploration of whether renal resistive index serves as a reliable marker, offering valuable insights into the potential diagnostic relevance for rheumatoid arthritis.
1 secondary outcome
Identify the risk factor for renal complication in RA patients
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Background: PubMed 28978936Li XF, Sun YY, Bao J, Chen X, Li YH, Yang Y, Zhang L, Huang C, Wu BM, Meng XM, Li J. Functional role of PPAR-gamma on the proliferation and migration of fibroblast-like synoviocytes in rheumatoid arthritis. Sci Rep. 2017 Oct 4;7(1):12671. doi: 10.1038/s41598-017-12570-6.
- Background: PubMed 34397890Jung JY, Kim YB, Kim JW, Suh CH, Kim HA. Biologic therapy for amyloid A amyloidosis secondary to rheumatoid arthritis treated with interleukin 6 therapy: Case report and review of literature. Medicine (Baltimore). 2021 Aug 13;100(32):e26843. doi: 10.1097/MD.0000000000026843.
- Background: PubMed 33204418Oweis AO, Alawneh KM, Alshelleh SA, Alnaimat F, Alawneh D, Zahran DJ. Renal dysfunction among rheumatoid arthritis patients: A retrospective cohort study. Ann Med Surg (Lond). 2020 Nov 4;60:280-284. doi: 10.1016/j.amsu.2020.11.011. eCollection 2020 Dec.
- Background: PubMed 17045630Alamanos Y, Voulgari PV, Drosos AA. Incidence and prevalence of rheumatoid arthritis, based on the 1987 American College of Rheumatology criteria: a systematic review. Semin Arthritis Rheum. 2006 Dec;36(3):182-8. doi: 10.1016/j.semarthrit.2006.08.006. Epub 2006 Oct 11.
- Background: PubMed 2189161Vollertsen RS, Conn DL. Vasculitis associated with rheumatoid arthritis. Rheum Dis Clin North Am. 1990 May;16(2):445-61.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating predictive value of renal resistive index in detection of rheumatoid arthritis. (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 NCT06227442, which also lists 5 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 26 Jan 2024.