The Renal Safety in Patients With Chronic HCV Undergoing... | NCT04169464

Studies
The Renal Safety in Patients With Chronic HCV Undergoing Sofosbuvir Containing Antiviral Therapy

NCT04169464

Sponsor

MTI University

Status

Unknown status

Last Update Posted

Nov 19, 2019Actual

Enrollment

200Estimated

Phase

Phase 4

Conditions

Egyptian Patients, HCV Treatment, Kidney Function

Interventions

Sofosbuvir Oral Product

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2019Actual

Primary Completion Date

Nov 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Nov 17, 2019

First Submission Date that Met QC Criteria

Nov 17, 2019

First Posted Date

Nov 19, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2019

Last Update Posted Date

Nov 19, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dalia Kamal Zaafar Ali, Lecturer of Pharmacology and Toxicology, MTI UniversityPrincipal Investigator

Lead Sponsor

MTI UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to investigate the occurrence of AKI during antiviral therapy, when compared with baseline values in Egyptian patients.

In addition, the study aims to evaluate the change in insulin resistance value after treating patients from HCV.

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 (Brawn et al., 2018).

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group I	Other	A group of HCV infected patients treated with DAA therapy including Sofospovir	Drug: Sofosbuvir Oral Product

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sofosbuvir Oral Product	Drug	to investigate the drug effect on renal function and insulin resistance	group I

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
occurance of AKI during therapy	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.	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age≥ 18 years Chronic infection with HCV GT 4 No prior HCV treatment experience

Exclusion Criteria:

Co-infection with HBV or HIV, clinical evidence of ischemic heart disease, the presence of diabetic ketoacidosis, Patients admitted to the intensive care unit (ICU), or expected to undergo surgery during the study period, and Child Pough score C.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dalia Zaafar, Phd	Lecturer of pharmacology and toxicology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Thabet Thabet hospital		Cairo		11311	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

IPD are accepted to be shared in some cases where patients code only used without individual name

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided