Cryoglobulinaemia Due to Chronic Hepatitis CNCT03476031
Pathology of Hepatitis c Nephropathy
An observational study of Cryoglobulinaemia Due to Chronic Hepatitis C, run by Assiut University at 1 site in Egypt.
Trial summary
Hepatitis c associated glomerulonephritis is an immune complex disease that occurs in 21% of patients who have HCV infection. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Cryoglobulinaemia Due to Chronic Hepatitis C
- What is being tested?
- renal biopsy
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2018to Dec 2019
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: prospective observational study
Who may be able to join
- it will be conducted on chronic hepatitis C patients with chronic kidney disease .
- The participants will be classified according to their estimated GFR by modified MDRD equation and
- they will be recruited from the renal unit of internal medicine, Assiut University Hospitals and assiut hepatitis viruses unit-ministry of health, Egypt.
Who cannot join
- Patients will be excluded if the underlying causes of CRF are as follows:
- chronic pyelonephritis,obstructive uropathy,Polycystic kidney disease,Patients with ESRD on regular hemodialysis,patients with advanced liver cirrhosis,hepatocellular carcinoma,Patients on steroids or immunosuppressive drugs and Solitary kidney.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Different Histopathological Patterns in Patients With HCV Nephropathy
Hepatitis c associated glomerulonephritis is an immune complex disease that occurs in 21% of patients who have HCV infection.
Read the detailed description
Hepatitis C virus infection is a major public health problem with an estimated global prevalence of 3% and an estimated 5-20% of infected patients will develop liver cirrhosis .The Prevalence of Hepatitis C infection in end stage renal disease is greater than in the general population especially in those on hemodialysis which reflects nosocomial transmission of the disease in the hemodialysis environment.
Hepatitis C associated glomerulonephritis is an immune complex disease that occurs in 21% of patients who have HCV infection. It most commonly presents as membranoproliferative and mixed cryoglobulinemia It characterized by an indolent course in one third of patients , remission in another third and relapsing course in the remaining patients with potential progression to advanced chronic kidney disease.
mechanism of injury : Chronic Hepatitis C is primarily associated with type II cryoglobulinemia , in which the primary mechanism of injury is vasculitis that occurs via immune complex deposition.
hepatitis C virus related glomerular disease :
Type I membranoproliferative was the most common finding associated with mixed cryoglobulinemia but other forms of glomerulonephritis were associated with Hepatitis c like mesangial glomerulonephritis,focal and segmental glomerulonephritis,minimal change nephropathy,membranous nephropathy , Fibrillary glomerulonephritis,immunotactoid glomerulopathy,IgA nephropathy, vasculitic renal involvement ,poly arteritis nodosa and interstitial nephritis .
- Being tested
- renal biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal biopsyDiagnostic test
needle biopsy will be taken from the kidney tissue then, diagnosed
| Study group | Role | What they receive |
|---|---|---|
| study group | patients with hepatitis c nephropathy detected by lab and renal biopsy Receives: Diagnostic Test: renal biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of histopathological pattern in patients with hepatitis C virus
prevalence of histopathological pattern in patients with hepatitis C virus
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study startNov 2018 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryoglobulinaemia Due to Chronic Hepatitis CStudies 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Essmat Mohammad, Assiut University
- Investigators
- Mohamed Tohammy, PhD, Study director, Faculty of medicine , internal medicine ,Assuit university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476031
- Sponsor's protocol ID
- DHPP
- Status last verified
- Mar 2018
- First submitted
- 18 Mar 2018
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Histopathological Patterns in Patients With HCV Nephropathy
- ClinicalTrials.gov ID
- NCT03476031
- Acronym / sponsor ID
- DHPP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 23 Mar 2018 (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.
Hepatitis c associated glomerulonephritis is an immune complex disease that occurs in 21% of patients who have HCV infection.
Detailed description
Hepatitis C virus infection is a major public health problem with an estimated global prevalence of 3% and an estimated 5-20% of infected patients will develop liver cirrhosis .The Prevalence of Hepatitis C infection in end stage renal disease is greater than in the general population especially in those on hemodialysis which reflects nosocomial transmission of the disease in the hemodialysis environment.
Hepatitis C associated glomerulonephritis is an immune complex disease that occurs in 21% of patients who have HCV infection. It most commonly presents as membranoproliferative and mixed cryoglobulinemia It characterized by an indolent course in one third of patients , remission in another third and relapsing course in the remaining patients with potential progression to advanced chronic kidney disease.
mechanism of injury : Chronic Hepatitis C is primarily associated with type II cryoglobulinemia , in which the primary mechanism of injury is vasculitis that occurs via immune complex deposition.
hepatitis C virus related glomerular disease :
Type I membranoproliferative was the most common finding associated with mixed cryoglobulinemia but other forms of glomerulonephritis were associated with Hepatitis c like mesangial glomerulonephritis,focal and segmental glomerulonephritis,minimal change nephropathy,membranous nephropathy , Fibrillary glomerulonephritis,immunotactoid glomerulopathy,IgA nephropathy, vasculitic renal involvement ,poly arteritis nodosa and interstitial nephritis .
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Diagnostic Test: renal biopsypatients with hepatitis c nephropathy detected by lab and renal biopsy |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- prospective observational study
Key inclusion criteria (3 listed)
- it will be conducted on chronic hepatitis C patients with chronic kidney disease .
- The participants will be classified according to their estimated GFR by modified MDRD equation and
- they will be recruited from the renal unit of internal medicine, Assiut University Hospitals and assiut hepatitis viruses unit-ministry of health, Egypt.
Key exclusion criteria (2 listed)
- chronic pyelonephritis,obstructive uropathy,Polycystic kidney disease,Patients with ESRD on regular hemodialysis,patients with advanced liver cirrhosis,hepatocellular carcinoma,Patients on steroids or immunosuppressive drugs and Solitary kidney.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| renal biopsyneedle biopsy will be taken from the kidney tissue then, diagnosed | Diagnostic test | study group |
Primary outcome
prevalence of histopathological pattern in patients with hepatitis C virus
Time frame: one year
prevalence of histopathological pattern in patients with hepatitis C virus
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
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.
Mohamed Tohammy, PhD study director
Faculty of medicine , internal medicine ,Assuit university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cryoglobulinaemia Due to Chronic Hepatitis C, 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 3 inclusion and 2 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 23 Mar 2018. 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 Mohammad Tohamy, MD (00201227270775, proftohammy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of histopathological pattern in patients with hepatitis C virus (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2018.