Investigate the Renal Effect of DAAs on Egyption Patients After Completion of Treatment
Conditions
Keywords
DAA, HCV, egyption patients
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.
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.
Interventions
OTHERevaluation 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
Sponsors
Cairo University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| investigate the renal injury which can be caused during using sofuspovir containing DAA regimen in HCV treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| highlight the effect of DAAs on insulin resistance in diabetic patients suffering from HCV | 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 |
Countries
Egypt
Contacts
Primary ContactDalia Zaafar, PhD
Backup Contactsoha hassanin, PhD
Outcome results
None listed