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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03476031
Other study ID # DHPP
Secondary ID
Status Not yet recruiting
Phase
First received March 18, 2018
Last updated March 18, 2018
Start date November 2018
Est. completion date December 2019

Study information

Verified date March 2018
Source Assiut University
Contact Mohammad Tohamy, MD
Phone 00201227270775
Email proftohammy@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Hepatitis c associated glomerulonephritis is an immune complex disease that occurs in 21% of patients who have HCV infection.


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 .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date December 2019
Est. primary completion date October 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
renal biopsy
needle biopsy will be taken from the kidney tissue then, diagnosed

Locations

Country Name City State
Egypt Assuit University Assuit

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary prevalence of histopathological pattern in patients with hepatitis C virus prevalence of histopathological pattern in patients with hepatitis C virus one year