Prevalence of Kidney Injury in Patients With HCV Treated With Sofuspovir Containing DAA Therapy

February 11, 2020 updated by: Dalia K. Zaafar, Cairo University

the Prevalence of Acute Kidney Injury in Patients With Chronic Hepatitis c Virus Receiving Sofuspovir Containing Direct Acting Antiviral Therapy

this study aims is to investigate the occurrence of AKI during antiviral therapy, defined as an increase of 0.3 mg/dL or 50% at least in serum creatinine level when compared with baseline values or more than a 25% reduction in (eGFR) when compared with baseline eGFR in Egyptian patients.In addition to evaluate the change in insulin resistance value after treating patients from HCV.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

There are limited published data, currently, suggesting the risk of AKI during oral direct acting antiviral treatment. Most case reports and retrospective studies reported the presence of an intrinsic cause of renal injury, with most of the available biopsies showing acute tubular necrosis (ATN) and acute interstitial nephritis (AIN). Most of these patients had returned to baseline renal function on cessation of sofosbuvir combination therapy.

Recently it was found that a notable percentage of patients experienced a transient increase in creatinine during therapy, which could occasionally lead to a more than 50% decrease in patients' eGFR. Previous studies had also shown that the co-use of nonsteroidal anti-inflammatory drugs (NSAIDs) and recurrent ascites were at increased risk for AKI during sofosbuvir-based antiviral therapy.

The primary endpoint of this study is to investigate the occurrence of AKI in Egyptian patients during antiviral therapy and to highlight its reasons and time of incidence in addition to the mechanism of this injury.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients suffering from HCV
  • male or female
  • easy to treat naive patients

Exclusion Criteria:

  • pregnant women
  • seffering from HBV
  • diffecult to treat
  • other comorbodities as heart diseases or COPD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: HCV infected patients with non-elevated sCr than basal levels
a group of egyption patients with HCV infection with non-elevated sCr than basal levels and treated with sofuspovir as an direct acting antiviral drug
Other: evaluation of sofuspovir containing DAA regien expected insult on kidney
to use different kidney biomarkers to evaluate acute kidney damage after using sofuspovir containing DAA regimen in treatment of HCV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
investigate the renal injury which can be caused during using sofuspovir containing DAA regimen in HCV treatment
Time Frame: from the start to 6 months later
to investigate effect of DAA on kidney of treated patients and the mechanism of the drug to cause this renal effect by causing renal buimarkers including NAG and eGFR
from the start to 6 months later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
highlight the effect of DAAs on insulin resistance in diabetic patients suffering from HCV
Time Frame: from the starting of treatment till the 3-months follow up after the end of the treatment regimen
to estimate the effect of DAAs on HOMA-IR index f insulin resistance in diabetic infected patients and comparing their insulin resistance before and after treatment
from the starting of treatment till the 3-months follow up after the end of the treatment regimen

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Dalia Zaafar, Phd, Lecturer of pharmacology and toxicology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Anticipated)

April 30, 2020

Study Completion (Anticipated)

December 30, 2020

Study Registration Dates

First Submitted

January 26, 2020

First Submitted That Met QC Criteria

February 11, 2020

First Posted (Actual)

February 12, 2020

Study Record Updates

Last Update Posted (Actual)

February 12, 2020

Last Update Submitted That Met QC Criteria

February 11, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 15-2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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