NCT03476031

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 23, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 23, 2018

Status Verified

March 1, 2018

Enrollment Period

11 months

First QC Date

March 18, 2018

Last Update Submit

March 18, 2018

Conditions

Cryoglobulinaemia Due to Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • prevalence of histopathological pattern in patients with hepatitis C virus

    prevalence of histopathological pattern in patients with hepatitis C virus

    one year

Study Arms (1)

study group

patients with hepatitis c nephropathy detected by lab and renal biopsy

Diagnostic Test: renal biopsy

Interventions

renal biopsyDIAGNOSTIC_TEST

needle biopsy will be taken from the kidney tissue then, diagnosed

study group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

prospective observational study

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit University

Asyut, 7115115, Egypt

Location

Study Officials

  • Mohamed Tohammy, PhD

    Faculty of medicine , internal medicine ,Assuit university

    STUDY DIRECTOR

Central Study Contacts

Mohammad Tohamy, MD

CONTACT

00201227270775proftohammy@yahoo.com

Effat Tony, MD

CONTACT

00201097330309Effattoni@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 18, 2018

First Posted

March 23, 2018

Study Start

November 1, 2018

Primary Completion

October 1, 2019

Study Completion

December 1, 2019

Last Updated

March 23, 2018

Record last verified: 2018-03

Locations

EG(1)