Assessment of Patients With Biopsy Proven Primary Glomerulonephritis Above 18 Years of Age for MFLD DevelopmentMFLDNCT06157125
Assessment of the Association Between Metabolic Associated Fatty Liver Disease (MFLD) and Biopsy Proved Cases of GN
An observational study of Assessment of Patients With Biopsy Proven Primary Glomerulonephritis Above 18 Years of Age for MFLD Development, run by Assiut University at 2 sites in Egypt.
Trial summary
Fatty liver disease is a global health concern with a prevalence of about 25% amongst United States. Its increased prevalence is attributed to increase in patients with obesity and metabolic syndrome (1). Diabetes mellitus (DM),obesity, hyperinsulinemia are predisposing factors for fatty liver disease(2). Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Assessment of Patients With Biopsy Proven Primary Glomerulonephritis Above 18 Years of Age for MFLD Development
- How many people
- 100 participants
- Where
- 2 sitesEgypt
- Study dates
- Jun 2024to Jul 2025
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inclusion Criteria: * Patients with biopsy proven primary glomerulonephritis. * Age >18 years Exclusion Criteria: 1. Patients with e-GFR<60ml/min/1.73m2 2. Patients with secondary glomerulonephritis 3. Patients with body mass index >35 kg/m2 4. Patients known to be diabetic. 5. Patients known to be hypertensive. 6. Patients with HCV or HBV infection either acute or chronic 7. Patients with acute hepatitis whatever the aetiology 8. Patients with autoimmune diseases
Who may be able to join
- Patients with biopsy proven primary glomerulonephritis.
- Age >18 years
Who cannot join
- Patients with e-GFR<60ml/min/1.73m2
- Patients with secondary glomerulonephritis
- Patients with body mass index >35 kg/m2
- Patients known to be diabetic.
- Patients known to be hypertensive.
- Patients with HCV or HBV infection either acute or chronic
- Patients with acute hepatitis whatever the aetiology
- Patients with autoimmune diseases
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 1 recruiting
- Recruiting
Assiut university hospitals nephrology department
Asyut, 71515
Assiut university, 0020882411900, med@aun.edu.eg
- Active, not recruiting
Assiut university hospitals nephrology department
Asyut, 71515
About this study
Official title: Assessment of the Association Between Metabolic Associated Fatty Liver Disease MFLD and Glomerulonephritis
Fatty liver disease is a global health concern with a prevalence of about 25% amongst United States. Its increased prevalence is attributed to increase in patients with obesity and metabolic syndrome (1). Diabetes mellitus (DM),obesity, hyperinsulinemia are predisposing factors for fatty liver disease(2). Glomerulonephritis (GN), a complex syndrome encompassing a variety of individual disorders, is associated with significant morbidity and mortality(3). Given its association with hyperlipidaemia, metabolic syndrome and long-term use of steroid there is concern that patients with GN may be at increased risk of fatty liver disease Patients with NS are frequently found to have fatty liver disease even when adjusting for common risk factors(1). It is known that obesity is an independent risk factor for CKD and it is associated with the development of proteinuria and pathologic findings of podocyte hypertrophy and focal segmental glomerular sclerosis even in the absence of diabetes and hypertension . In addition, studies have shown that obesity as well as metabolic syndrome is a strong predictor of the development of fatty liver disease (4) . Hence, clinicians should maintain a high index of suspicion regarding presence of NAFLD in patients with NS
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the association between MFLD and GN
Assessment of the association between MFLD and GN
Measured: Within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study startJun 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Assessment of Patients With Biopsy Proven Primary Glomerulonephritis Above 18 Years of Age for MFLD DevelopmentStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randa Abd Elkader Anwar, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157125
- Sponsor's protocol ID
- MFLD and GN
- Acronym
- MFLD
- Status last verified
- Nov 2023
- First submitted
- 27 Nov 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Amarapurkar D, Kamani P, Patel N, Gupte P, Kumar P, Agal S, Baijal R, Lala S, Chaudhary D, Deshpande A. Prevalence of non-alcoholic fatty liver disease: population based study. Ann Hepatol. 2007 Jul-Sep;6(3):161-3.
PubMed 17786142Wetmore JB, Guo H, Liu J, Collins AJ, Gilbertson DT. The incidence, prevalence, and outcomes of glomerulonephritis derived from a large retrospective analysis. Kidney Int. 2016 Oct;90(4):853-60. doi: 10.1016/j.kint.2016.04.026. Epub 2016 Jul 15.
PubMed 27425855Marcuccilli M, Chonchol M. NAFLD and Chronic Kidney Disease. Int J Mol Sci. 2016 Apr 14;17(4):562. doi: 10.3390/ijms17040562.
PubMed 27089331Onwuzo SS, Hitawala AA, Boustany A, Kumar P, Almomani A, Onwuzo C, Monteiro JM, Asaad I. Prevalence of non-alcoholic fatty liver disease in patients with nephrotic syndrome: A population-based study. World J Hepatol. 2023 Feb 27;15(2):265-273. doi: 10.4254/wjh.v15.i2.265.
PubMed 36926242
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Association Between Metabolic Associated Fatty Liver Disease MFLD and Glomerulonephritis
- ClinicalTrials.gov ID
- NCT06157125
- Acronym / sponsor ID
- MFLD / MFLD and GN
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 5 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fatty liver disease is a global health concern with a prevalence of about 25% amongst United States. Its increased prevalence is attributed to increase in patients with obesity and metabolic syndrome (1). Diabetes mellitus (DM),obesity, hyperinsulinemia are predisposing factors for fatty liver disease(2). Glomerulonephritis (GN), a complex syndrome encompassing a variety of individual disorders, is associated with significant morbidity and mortality(3). Given its association with hyperlipidaemia, metabolic syndrome and long-term use of steroid there is concern that patients with GN may be at increased risk of fatty liver disease Patients with NS are frequently found to have fatty liver disease even when adjusting for common risk factors(1). It is known that obesity is an independent risk factor for CKD and it is associated with the development of proteinuria and pathologic findings of podocyte hypertrophy and focal segmental glomerular sclerosis even in the absence of diabetes and hypertension . In addition, studies have shown that obesity as well as metabolic syndrome is a strong predictor of the development of fatty liver disease (4) . Hence, clinicians should maintain a high index of suspicion regarding presence of NAFLD in patients with NS
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion Criteria: * Patients with biopsy proven primary glomerulonephritis. * Age >18 years Exclusion Criteria: 1. Patients with e-GFR<60ml/min/1.73m2 2. Patients with secondary glomerulonephritis 3. Patients with body mass index >35 kg/m2 4. Patients known to be diabetic. 5. Patients known to be hypertensive. 6. Patients with HCV or HBV infection either acute or chronic 7. Patients with acute hepatitis whatever the aetiology 8. Patients with autoimmune diseases
Key inclusion criteria (2 listed)
- Patients with biopsy proven primary glomerulonephritis.
- Age >18 years
Key exclusion criteria (8 listed)
- Patients with e-GFR<60ml/min/1.73m2
- Patients with secondary glomerulonephritis
- Patients with body mass index >35 kg/m2
- Patients known to be diabetic.
- Patients known to be hypertensive.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of the association between MFLD and GN
Time frame: Within 1 year
Assessment of the association between MFLD and GN
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Background: PubMed 17786142Amarapurkar D, Kamani P, Patel N, Gupte P, Kumar P, Agal S, Baijal R, Lala S, Chaudhary D, Deshpande A. Prevalence of non-alcoholic fatty liver disease: population based study. Ann Hepatol. 2007 Jul-Sep;6(3):161-3.
- Background: PubMed 27425855Wetmore JB, Guo H, Liu J, Collins AJ, Gilbertson DT. The incidence, prevalence, and outcomes of glomerulonephritis derived from a large retrospective analysis. Kidney Int. 2016 Oct;90(4):853-60. doi: 10.1016/j.kint.2016.04.026. Epub 2016 Jul 15.
- Background: PubMed 27089331Marcuccilli M, Chonchol M. NAFLD and Chronic Kidney Disease. Int J Mol Sci. 2016 Apr 14;17(4):562. doi: 10.3390/ijms17040562.
- Results publication: PubMed 36926242Onwuzo SS, Hitawala AA, Boustany A, Kumar P, Almomani A, Onwuzo C, Monteiro JM, Asaad I. Prevalence of non-alcoholic fatty liver disease in patients with nephrotic syndrome: A population-based study. World J Hepatol. 2023 Feb 27;15(2):265-273. doi: 10.4254/wjh.v15.i2.265.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Assessment of Patients With Biopsy Proven Primary Glomerulonephritis Above 18 Years of Age for MFLD Development, run by Assiut University at 2 sites 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 2 inclusion and 8 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 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the association between MFLD and GN (time frame: Within 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 NCT06157125, which also lists 4 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 5 Dec 2023.