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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04267458
Recruitment Status : Recruiting
First Posted : February 12, 2020
Last Update Posted : February 12, 2020
Information provided by (Responsible Party):
Dalia K. Zaafar, Cairo University

Brief 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.

Condition or disease Intervention/treatment Phase
Investigate the Renal Effect of DAAs on Egyption Patients After Completion of Treatment Other: evaluation of sofuspovir containing DAA regien expected insult on kidney Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: the Prevalence of Acute Kidney Injury in Patients With Chronic Hepatitis c Virus Receiving Sofuspovir Containing Direct Acting Antiviral Therapy
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : December 30, 2020

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04267458

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Contact: Dalia Zaafar, PhD 00201117922833
Contact: soha hassanin, PhD

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Thabet Thabet Hospital For Internal Diseases Recruiting
Cairo, Egypt, 11311
Contact: dalia zaafar, phd   
Contact: soha hassanin, phd   
Sponsors and Collaborators
Cairo University
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Principal Investigator: Dalia Zaafar, PhD Lecturer of pharmacology and toxicology
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Responsible Party: Dalia K. Zaafar, lecturer of pharmacology, Cairo University Identifier: NCT04267458    
Other Study ID Numbers: 15-2019
First Posted: February 12, 2020    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020

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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
Keywords provided by Dalia K. Zaafar, Cairo University:
egyption patients