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Status unknownNCT05516511Updated Nov 9, 2022

Serum Levels of Angiotensin Converting Enzyme in Systemic Lupus Erythematous Patients

An observational study in Systemic Lupus Erythematosus, sponsored by Sohag University. Status unknown at 1 site in Egypt. Open to participants aged 17 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-09.

Sponsored by Sohag University · Observational

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
75
Ages
17 Years to 60 Years
Sex
All
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Study summary

Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease that involve many different organs and display a variable clinical course.The prevalence of SLE varies across gender, race/ethnicity, and geographic regions. SLE demonstrates a striking female predominance with a peak incidence of disease during the reproductive years. In adults, the female to male ratio is 10- Renal involvement is common in SLE and is a significant cause of morbidity and mortality. It is estimated that as many as 90% of patients with SLE will have pathologic evidence of renal involvement on biopsy, but clinically significant nephritis will develop in only 50%. AII is a potent pro-inflammatory modulator with the ability to augment the immune responses in renal and non-renal tissues. Specifically in the kidney, AII stimulates mononuclear cells, favoring hyperplasia and hypertrophy of mesangial, tubular cells and interstitial fibroblasts, and increases expression and synthesis of the extracellular protein matrix leading to fibrosis.

Angiotensin II and strong candidate for a mediator of the development and progression of renal disease in SLE has been found to promote glomerular cell proliferation, alter growth factor expression, and activate proinflammatory cytokines, all of which promote glomerulosclerosis

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Conditions studied

  • Systemic Lupus Erythematosus
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In context

Lupus Erythematosus, Systemic

1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's planned enrollment of 75 is below the median of 140 across 283 observational studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
17 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

The study will include 50 patients diagnosed by 2019 American College of Rheumatology/European League Against Rheumatism classification criteria as systemic lupus erythematosus, 25of them will be selected as Lupus Nephritis (LN).

  • 25 normal healthy persons matched for age and sex as control group.

Inclusion criteria

  • 1-Patients who fulfill the 2019 American College of Rheumatology/European League against Rheumatism classification criteria of Systemic Lupus Erythematosus 2-Patients diagnosed as lupus nephritis , actually did renal biobsy 3-Patients who is able to give informed consent to join the study

Exclusion criteria

Exclusion Criteria:

    • Any patient with any collagen disease other than systemic lupus erythematosus.
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Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
75 participants (estimated)
Patient registry
No

Groups and cohorts

  • cases

    systemic lupus erythematosus patients

    Diagnostic Test: Angiotensin Converting Enzyme test

  • control

    healthy individuals

    Diagnostic Test: Angiotensin Converting Enzyme test

Interventions

  • Diagnostic testAngiotensin Converting Enzyme test

    blood sample is taken SLE patients , healthy control , ACE level will be measured by ELISA kits

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What researchers measure

Primary outcomes

  1. Angiotensin Converting Enzyme test

    laboratory test, ELISA kits, measure serum levels of angiotensin converting enzyme in SLE patients , control

    Time frame: 3 months

  2. protein creatine ratio

    laboratory test, urine sample used to measure amount of proteinurea

    Time frame: 3 months

  3. serum creatine test

    lab test , to asses renal function

    Time frame: 3 months

Secondary outcomes

  1. Anti nuclear Anti body tset

    lab tset, IF technique, for diagnosis of SLE disease

    Time frame: 3 months

  2. anti ds-DNA test

    lab test , for diagnosis of SLE , lupus nephritis

    Time frame: 3 months

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Study locations

1 site
  • Sohag University Hospital
    Sohag, Egypt
    • osama R Elsherief, professor · Contact
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References and documents

Publications

  • Pons-Estel GJ, Alarcon GS, Scofield L, Reinlib L, Cooper GS. Understanding the epidemiology and progression of systemic lupus erythematosus. Semin Arthritis Rheum. 2010 Feb;39(4):257-68. doi: 10.1016/j.semarthrit.2008.10.007. Epub 2009 Jan 10. PubMed 19136143 ↗
  • Weening JJ, D'Agati VD, Schwartz MM, Seshan SV, Alpers CE, Appel GB, Balow JE, Bruijn JA, Cook T, Ferrario F, Fogo AB, Ginzler EM, Hebert L, Hill G, Hill P, Jennette JC, Kong NC, Lesavre P, Lockshin M, Looi LM, Makino H, Moura LA, Nagata M; International Society of Nephrology Working Group on the Classification of Lupus Nephritis; Renal Pathology Society Working Group on the Classification of Lupus Nephritis. The classification of glomerulonephritis in systemic lupus erythematosus revisited. Kidney Int. 2004 Feb;65(2):521-30. doi: 10.1111/j.1523-1755.2004.00443.x. Erratum In: Kidney Int. 2004 Mar;65(3):1132. PubMed 14717922 ↗
  • Ruiz-Ortega M, Ruperez M, Esteban V, Rodriguez-Vita J, Sanchez-Lopez E, Carvajal G, Egido J. Angiotensin II: a key factor in the inflammatory and fibrotic response in kidney diseases. Nephrol Dial Transplant. 2006 Jan;21(1):16-20. doi: 10.1093/ndt/gfi265. Epub 2005 Nov 9. PubMed 16280370 ↗
  • Klahr S, Morrissey JJ. The role of vasoactive compounds, growth factors and cytokines in the progression of renal disease. Kidney Int Suppl. 2000 Apr;75:S7-14. PubMed 10828755 ↗

Individual participant data

Plan to share: Yes

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05516511
Lead sponsor
Sohag University
Responsible party
Yasmin Abdelfattah Mohamed (resident doctor at Physical medicine,Rheumatolgy and Rehabilitaion Department , Faculty of medicine, Sohag University, Sohag University) — Principal investigator
First posted
Aug 25, 2022
Start date
Jan 2023 (estimated)
Primary completion
Mar 2023 (estimated)
Completion
Mar 2023 (estimated)
Last update
Nov 9, 2022

Study contacts

Yasmine A Mohamed, resident
Contact
yasmine_abdelfattah_post@med.sohag.edu.eg
01032071095
Mohamed A Ismail, assisstant professor
Contact

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 status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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