Prevalence and Pathological Features of C3 Dominant Glomerulonephritis Among Egyptian Population

November 10, 2023 updated by: Alaa Ali Taha, Sohag University

A classification has introduced C3 glomerulopathy (C3 glomerulopathy consensus report) that should be used to designate a disease process due to abnormal control of complement activation, deposition, or degradation and characterized by predominant glomerular C3 fragment deposits with EM dense deposits. Also, the consensus suggested that the term glomerulonephritis with dominant C3 should be used in practice as a morphological term for those cases with dominant C3 (C3c satining) which is defined as C3 intensity ≥ 2 orders of magnitude more than any other immune reactant on a scale of 0 to 3.

C3 glomerulonephritis with 3 dominant C3 deposits include C3 glomerulopathy, post-infectious glomerulonephritis (PIGN) and others such as para-protein associated glomerulonephritis.

In C3 glomerulopathy; the alternative pathway plays a major role in pathogenesis of this group of diseases. It occurs because of dysregulation of alternative complement pathway. Dysregulation can be due to mutations of complement proteins or to autoantibodies that promote complement activation.

Classical/lectin complement pathway has shown potential in evaluation of C3 glomerulopathy. It's suggested that presence of glomerular C4d which is a product of early classical/lectin pathway, should not exclude a C3 glomerulopathy.

Another disease group with prominent C3 deposits is postinfectious glomerulonephritis (PIGN) and although PIGN has traditionally been thought of as a disease triggered by glomerular immune complex deposition but C3 deposition in absence of immune complex deposits can be seen in patients with PIGN but with the emergence of C3 glomerulonephritis (C3GN), the distinction is difficult as the clinical and pathological presentation may be similar. However, their treatment and clinical course vary significantly.

In addition there is overlap between PIGN and C3 glomerulopathy as they may both show prominent sub-epithelial humps on electron microscopy. This overlap means that it may be very difficult to decide on morphology alone whether a biopsy is a typical PIGN that will resolve, or whether it represents a C3 glomerulopathy due to an underlying complement abnormality that will lead to persistent glomerulonephritis.

Study Overview

Status

Status

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Recruiting

Conditions

Conditions

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Study Type

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Observational

Enrollment (Estimated)

Enrollment

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100

Contacts and Locations

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Study Contact

Study Contact

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Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag university , faculty of medicine

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

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Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Formalin-fixed and paraffin embedded renal tissue blocks from 100 patients.

Description

Inclusion Criteria:

  1. Adequate sample with at least 10 glomeruli
  2. Enough residual tissues in the paraffin blocks
  3. Available clinical data

Exclusion Criteria:

Other glomerular diseases such as lupus nephritis, IgA nephropathy, membranous glomerulonephritis and immune complex-mediated membranoproliferative GN. Cases of minimal change were also excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To estimate the prevalence of C3 dominant glomerulonephritis
Time Frame: One or two days after staining sections with the markers
C3 dominant glomerulonephritis
One or two days after staining sections with the markers

Collaborators and Investigators

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Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sohag University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alaa Taha, Sohag university, faculty of medicine, Egypt

Study record dates

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Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2024

Study Completion (Estimated)

Study Completion

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December 1, 2024

Study Registration Dates

First Submitted

First Submitted

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November 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Soh-Med-23-10-12MD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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