The Renal Safety and Rates of Acute Kidney Injury (AKI) in Patients With Chronic HCV Undergoing Sofosbuvir Containing Direct Acting Antiviral Therapy
The Renal Safety in Patients With Chronic HCV Undergoing Sofosbuvir Containing Antiviral Therapy
Sponsors
Source
MTI University
Oversight Info
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
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.
Overall Status
Enrolling by invitation
Start Date
2019-04-01
Completion Date
2019-12-01
Primary Completion Date
2019-11-01
Phase
Phase 4
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
occurance of AKI during therapy |
3 months |
Enrollment
200
Condition
Intervention
Intervention Type
Drug
Intervention Name
Description
to investigate the drug effect on renal function and insulin resistance
Arm Group Label
group I
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.
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Dalia Zaafar, Phd |
Principal Investigator |
Lecturer of pharmacology and toxicology |
Location
Facility |
|
Thabet Thabet hospital Cairo 11311 Egypt |
Location Countries
Country
Egypt
Verification Date
2019-11-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
MTI University
Investigator Full Name
Dalia Kamal Zaafar Ali
Investigator Title
Lecturer of Pharmacology and Toxicology
Keywords
Has Expanded Access
No
Number Of Arms
1
Intervention Browse
Mesh Term
Antiviral Agents
Sofosbuvir
Arm Group
Arm Group Label
group I
Arm Group Type
Other
Description
A group of HCV infected patients treated with DAA therapy including Sofospovir
Firstreceived Results Date
N/A
Patient Data
Sharing Ipd
No
Ipd Description
IPD are accepted to be shared in some cases where patients code only used without individual name
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Study First Submitted
November 17, 2019
Study First Submitted Qc
November 17, 2019
Study First Posted
November 19, 2019
Last Update Submitted
November 17, 2019
Last Update Submitted Qc
November 17, 2019
Last Update Posted
November 19, 2019
ClinicalTrials.gov processed this data on December 05, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.