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

Investigate the Renal Effect of DAAs on Egyption Patients After Completion of Treatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04267458
• Other study ID #: 15-2019
• Status: Recruiting
• Phase: Phase 4
• Start date: July 1, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: February 2020
• Source: Cairo University
• Contact: Dalia Zaafar, PhD
• Phone: 00201117922833
• Email: dr.moda88[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Investigate the Renal Effect of DAAs on Egyption Patients After Completion of Treatment

Intervention

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

Locations

Country	Name	City	State
Egypt	Thabet Thabet Hospital For Internal Diseases	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	investigate the renal injury which can be caused during using sofuspovir containing DAA regimen in HCV treatment	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	highlight the effect of DAAs on insulin resistance in diabetic patients suffering from HCV	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