- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06126471
Prevalence and Pathological Features of C3 Dominant Glomerulonephritis Among Egyptian Population
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
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Alaa Taha
- Phone Number: 01000389590
- Email: alaa_ali_taha154@yahoo.com
Study Locations
-
-
-
Sohag, Egypt
- Recruiting
- Sohag university , faculty of medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adequate sample with at least 10 glomeruli
- Enough residual tissues in the paraffin blocks
- 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
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
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
Sponsor
Investigators
- Principal Investigator: Alaa Taha, Sohag university, faculty of medicine, Egypt
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-23-10-12MD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on C3 Nephropathy
-
Suzhou Sanegene Bio Inc.Not yet recruitingIC-MPGN | C3 Glomerulopathy | IgA Nephropathy (IgAN)China
-
NovelMed TherapeuticsNot yet recruitingC3 Glomerulopathy
-
Novartis PharmaceuticalsRecruiting
-
Novartis PharmaceuticalsRecruiting
-
Apellis Pharmaceuticals, Inc.CompletedLupus Nephritis | IgA Nephropathy | Membranous Nephropathy | C3 Glomerulonephritis | Dense Deposit DiseaseUnited States
-
Alexion PharmaceuticalsCompletedC3 Glomerulopathy | C3 Glomerulonephritis | Dense Deposit DiseaseUnited Kingdom, United States
-
Arrowhead PharmaceuticalsCompletedIgA Nephropathy | C3 GlomerulopathyNew Zealand, Australia, Germany, Thailand, United Kingdom, Georgia, South Korea
-
University of CopenhagenRecruitingHealhty | Other: Short-Chain Fatty Acid (SCFA) | Other: Butyrate (C4) | Other: Propionate (C3)Denmark
-
Pierre Fabre MedicamentEurotrials Brasil Consultores Cientificos LtdaWithdrawnVenous Disease Classification (CEAP): C2 or C3
-
Mario Negri Institute for Pharmacological ResearchAlexion PharmaceuticalsCompletedIC-MPGN | C3 Glomerulopathy | C3 Glomerulonephritis | Dense Deposit Disease | Immune Complex Membranoproliferative GlomerulonephritisItaly