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Uric AcidNCT05402735

Value of Uric Acid as Early Predictor of Lupus Nephritis

An observational study of Uric Acid, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of the present work is to determine the role of uric acid as a predictor and prognostic factor in the development of lupus nephritis. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Uric Acid
What is being tested?
Serum uric acid level
How many people
100 participants
Where
1 siteEgypt
Study dates
15 Jun 2022to 25 Aug 2023
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 75 years
  • All sexes
  • Adult, Older adult

Study population: All patients fulfilled the European League Against Rheumatism (EULAR) and the American college of rheumatology (ACR)

Who may be able to join

  • All patients fulfilled the European League Against Rheumatism (EULAR) and the American college of rheumatology (ACR)

Who cannot join

  • Exclusion criteria were the use of diuretics, aspirin, cyclosporine, or any drugs affect level of uric acid Also exlude patients with hypertension, diabetes , dyslipidemia and obesity

Trial locations and contacts

1 site in 1 country.

Eman gamal neyaz contact

01060893042

geman3171@gmail.com

Salwa Salah Eldeen Elgendi salah contact

01005766155

salwaelgendi@yahoo.com

Egypt1 site, 1 recruiting

  • assuit University

    Asyut

    Eman gamal

    salwa salah

    Recruiting

Other trials in Egypt

About this study

Official title: Value of Uric Acid as Early Predictor of Lupus Nephritis in Assiut University Hospital

The aim of the present work is to determine the role of uric acid as a predictor and prognostic factor in the development of lupus nephritis.

Read the detailed description

Systemic Lupus Erythematosus (SLE) is a systemic autoimmune disorder identified by the production of autoantibodies and immune complex deposition [1]. It presents with a variety of unpredictable flares of disease activity and irreversible organ damage [2]. Half or more (45%-85%) of patients with SLE will develop Lupus Nephritis (LN) over the course of their lifetime, which is a major concern [3,4]. Despite advanced immunosuppressive therapy, the 5-year survival rate of SLE patients with severe renal damage (11%-33%) is usually very low [5].

Hence, early prediction and diagnosis of LN are of great value. So far, renal biopsy remains to be the gold standard tool for diagnosis of LN [6] and assumes a vital role in its management and prognosis. However, renal biopsy can have various complications including hemorrhage and infection. Besides, some patients have contraindications for renal biopsy, which indicates the requirement for noninvasive markers for evaluating renal dysfunction and its grade [7].

  • Elimination of serum uric acid (SUA), the circulating endproduct of purine metabolism, occurs via both renal and extrarenal (gastrointestinal tract) pathways [8]. Kang and colleagues [9] have reported that elevated serum uric acid may also be a risk factor for progression of renal disease, in spite of the fact that it is considered as one of the markers of renal dysfunction. Elevated serum uric acid itself can lead to kidney damage without the deposition of uric acid crystals as reported in different studies [10]. Other studies strongly suggest to consider the concept of asymptomaticity for chronic hyperuricemia and hence to check the normal level of serum uric acid levels [11].

Hyperuricemia can be observed in patients with diabetic nephropathy , IgA nephropathy , metabolic syndrome and cardiovascular diseases [12,13,14,15]. In addition, a noteworthy positive relationship was detected between serum level of uric acid and new onset lupus nephritis. Elevated sUA has been observed as an independent risk factor for the development of LN . The correlation between sUA and the degree of renal dysfunction in LN patients was previously analyzed but in a few studies as in Calich and colleagues study who reported an association between lupus nephritis and high serum UA . Therefore the aim of the current study was to evaluate serum uric acid level and detect if hyperuricemia can independently predict and affect prognosis of LN among SLE patients.

Conditions
Uric Acid
Being tested
Serum uric acid level

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Serum uric acid levelDiagnostic test

    Serum uric acid level

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Value of uric acid as early predictor of lupus nephritis in Assiut University hospital

    The aim of the present work is to determine the role of uric acid as a predictor and prognostic factor in the development of lupus nephritis.

    The aim of the present work is to determine the role of uric acid as a predictor and prognostic factor in the development of lupus nephritis.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2022
  2. Study start15 Jun 2022 (estimated)
  3. Primary completion12 Jul 2023 (estimated)
  4. Study completion25 Aug 2023 (estimated)

Resources

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 only
Time perspective
Cross-sectional
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05402735
Sponsor's protocol ID
Serum uric acid in SLE
Status last verified
May 2022
First submitted
29 May 2022
Last updated
2 Jun 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Yuan W, DiMartino SJ, Redecha PB, Ivashkiv LB, Salmon JE. Systemic lupus erythematosus monocytes are less responsive to interleukin-10 in the presence of immune complexes. Arthritis Rheum. 2011 Jan;63(1):212-8. doi: 10.1002/art.30083.

    PubMed 20954190

  • Borchers AT, Leibushor N, Naguwa SM, Cheema GS, Shoenfeld Y, Gershwin ME. Lupus nephritis: a critical review. Autoimmun Rev. 2012 Dec;12(2):174-94. doi: 10.1016/j.autrev.2012.08.018. Epub 2012 Sep 8.

    PubMed 22982174

  • Zubair A, Frieri M. Lupus nephritis: review of the literature. Curr Allergy Asthma Rep. 2013 Dec;13(6):580-6. doi: 10.1007/s11882-013-0394-4.

    PubMed 24234325

  • Koutsokeras T, Healy T. Systemic lupus erythematosus and lupus nephritis. Nat Rev Drug Discov. 2014 Mar;13(3):173-4. doi: 10.1038/nrd4227. Epub 2014 Feb 14. No abstract available.

    PubMed 24525782

  • Cameron JS, Hicks J. The introduction of renal biopsy into nephrology from 1901 to 1961: a paradigm of the forming of nephrology by technology. Am J Nephrol. 1997;17(3-4):347-58. doi: 10.1159/000169122.

    PubMed 9189255

  • Xie T, Chen M, Tang X, Yin H, Wang X, Li G, Li J, Zuo X, Zhang W. Hyperuricemia is an independent risk factor for renal pathological damage and poor prognosis in lupus nephritis patients. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2016 Oct 28;41(10):1052-1057. doi: 10.11817/j.issn.1672-7347.2016.10.007.

    PubMed 27807327

  • Kang DH, Nakagawa T, Feng L, Watanabe S, Han L, Mazzali M, Truong L, Harris R, Johnson RJ. A role for uric acid in the progression of renal disease. J Am Soc Nephrol. 2002 Dec;13(12):2888-97. doi: 10.1097/01.asn.0000034910.58454.fd.

    PubMed 12444207

  • Desideri G, Castaldo G, Lombardi A, Mussap M, Testa A, Pontremoli R, Punzi L, Borghi C. Is it time to revise the normal range of serum uric acid levels? Eur Rev Med Pharmacol Sci. 2014;18(9):1295-306.

    PubMed 24867507

  • Mazzali M, Hughes J, Kim YG, Jefferson JA, Kang DH, Gordon KL, Lan HY, Kivlighn S, Johnson RJ. Elevated uric acid increases blood pressure in the rat by a novel crystal-independent mechanism. Hypertension. 2001 Nov;38(5):1101-6. doi: 10.1161/hy1101.092839.

    PubMed 11711505

  • Liu P, Chen Y, Wang B, Zhang F, Wang D, Wang Y. Allopurinol treatment improves renal function in patients with type 2 diabetes and asymptomatic hyperuricemia: 3-year randomized parallel-controlled study. Clin Endocrinol (Oxf). 2015 Oct;83(4):475-82. doi: 10.1111/cen.12673. Epub 2014 Dec 29.

    PubMed 25400252

  • Cheng GY, Liu DW, Zhang N, Tang L, Zhao ZZ, Liu ZS. Clinical and prognostic implications of serum uric acid levels on IgA nephropathy: a cohort study of 348 cases with a mean 5-year follow-up. Clin Nephrol. 2013 Jul;80(1):40-6. doi: 10.5414/CN107813.

    PubMed 23391320

  • Li C, Hsieh MC, Chang SJ. Metabolic syndrome, diabetes, and hyperuricemia. Curr Opin Rheumatol. 2013 Mar;25(2):210-6. doi: 10.1097/BOR.0b013e32835d951e.

    PubMed 23370374

  • Sertoglu E. Serum uric acid: an independent predictive marker for coronary artery disease. Clin Rheumatol. 2015 Sep;34(9):1659. doi: 10.1007/s10067-015-2919-9. Epub 2015 Mar 22. No abstract available.

    PubMed 25796387

Questions about this trial

What is this clinical trial studying?

An observational study of Uric Acid, run by Assiut University at 1 site in Egypt.

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 1 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 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Contact Eman gamal neyaz (01060893042, geman3171@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Value of uric acid as early predictor of lupus nephritis in Assiut University hospital (time frame: 1 year). 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 NCT05402735, which also lists 13 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 2 Jun 2022.

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