Uromodulin in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Uromodulin Levels in Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03972098
• Other study ID #: Gaziosmanpasa Hospital
• Status: Completed
• Start date: May 1, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: May 2019
• Source: Istanbul Saglik Bilimleri University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the present study was to evaluate the levels of uromodulin in rheumatoid arthritis (RA) and to investigate whether it was correlated with baseline clinical characteristics. In addition CKD epi,MDRD,urine microalbuminuria,pH,serum urea, creatinine,CRP (C-Reactive protein) were measured.The participants consist of ; %68 patients,% 32 control group.

Description:

Uromodulin, also known as Tamm-Horsfall protein, is a protein abundantly excreted in the urine in healthy individuals. It is synthesized in the thick ascending limb of Henle (TALH) and the early distal convoluted tubule. Its biologic function is still obscure; however, some experimental studies indicated that it might serve as an important urinary defense factor against bacterial colonization and stone formation.

There are controversial publications on the frequencies of urinary tract infections and nephrolithiasis in patients with mutations of uromodulin gene. Deposition of mutated uromodulin in the urinary system may lead to tubular cell dysfunction and apoptosis. These alterations may subsequently cause tubular atrophy and interstitial fibrosis . Moreover, the release of abnormal uromodulin after apoptosis through basolateral secretion may elicit an immune response which may give rise to an immune-mediated tubulointerstitial nephritis .

Uromodulin can activate the other components of the immune system and may modulate the inflammatory and immune responses through different mechanisms .

Experimental studies yielded that uromodulin negative mice displayed splenomegaly with infiltration of white pulp by macrophages and increased levels of TNF-α and interleukin-1 . Rheumatoid arthritis is a systemic autoimmune condition that may eventually result in the joint damage, disability and premature mortality.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: June 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who diagnosed of rheumatoid arthritis as criteria of ACR/EULAR 2010.

• All patients age range is 18-80 years.

Exclusion Criteria :

• Renal failure

• Hepatic insufficiency

• Diabetes mellitus

• Other collagen vascular diseases,

• History of smoking and consumption of alcohol

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Turkey	Istanbul saglik Bilimleri Universty Gaziosmanpasa Egitim ve Arastirma Hastanesi	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
neval aksoy

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients with rheumatoid arthritis	The diagnosis of RA was based on the criteria the American College of Rheumatology and European League Against Rheumatism (ACR/EULAR) in 2010.; Patients selected; have at least 1 joint with definite clinical synovitis (swelling); with the synovitis not better explained by another disease Classification criteria for RA (score-based algorithm: add score of categories A-D; a score of >6/10 is needed for classification of a patient as having definite RA)	1 day
Primary	A.joint involvement	1 large joint (score 0) 2-10 large joints (score 1) 1-3 small joints (with or without involvement of large joints)#(score2) 4-10 small joints (with or without involvement of large joints)(score 3) 10 joints (at least 1 small joint) (score 5)	1 day
Primary	B.Serology (at least 1 test result is needed for classification)	Negative RF and negative ACPA (Score 0) Low-positive RF or low-positive ACPA( anticitrullinated protein antibody) (score 2) High-positive RF(rheumatoid factor) or high-positive ACPA (score 3)	1 day
Primary	C.Acute-phase reactants (at least 1 test result is needed for classification)	Normal CRP (C-reactive protein and normal) and normal ESR (erythrocyte sedimentation rate) (score 0) Abnormal CRP or abnormal ESR (score1)	1 day
Primary	D.Duration of symptoms	<6 weeks (score 0) >6 weeks (score 1)	1 day
Primary	Uromodulin measure	First urine sample taken in the morning	1 day
Secondary	CKD-EPI (Chronic Kidney Disease Epidemiology Colloboration)	For estimating the glomerular filtration rate	1 day
Secondary	MDRD (Modification of Diet in Renal Disease)	For estimating the glomerular filtration rate	1 day
Secondary	Urea measure	Fasting blood samples taken in the morning	1 day
Secondary	Creatinine measure	Fasting blood samples taken in the morning	1 day
Secondary	Sedimantation measure	Fasting blood samples taken in the morning	1 day
Secondary	pH measure	First urine sample taken in the morning	1 day
Secondary	Microalbuminuria measure	First urine sample taken in the morning	1 day