Investigate the Renal Effect of DAAs on Egyption Patients After Completion of TreatmentPhase 4NCT04267458
Prevalence of Kidney Injury in Patients With HCV Treated With Sofuspovir Containing DAA Therapy
A Phase 4 study testing evaluation of sofuspovir containing DAA regien expected insult on kidney in people with Investigate the Renal Effect of DAAs on Egyption Patients After Completion of Treatment, run by Cairo University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Investigate the Renal Effect of DAAs on Egyption Patients After Completion of Treatment
- What is being tested?
- evaluation of sofuspovir containing DAA regien expected insult on kidney
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2019to 30 Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients suffering from HCV
- male or female
- easy to treat naive patients
Who cannot join
- pregnant women
- seffering from HBV
- diffecult to treat
- other comorbodities as heart diseases or COPD
Trial locations and contacts
1 site in 1 country.
soha hassanin, PhD contact
Egypt1 site, 1 recruiting
- Recruiting
Thabet Thabet Hospital For Internal Diseases
Cairo, 11311
dalia zaafar, phd, dr.moda88@gmail.com
soha hassanin, phd, phsoha@hotmail.com
About this study
Official title: the Prevalence of Acute Kidney Injury in Patients With Chronic Hepatitis c Virus Receiving Sofuspovir Containing Direct Acting Antiviral Therapy
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.
Read the 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.
- Being tested
- evaluation of sofuspovir containing DAA regien expected insult on kidney
- Keywords
- DAA, HCV, egyption patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluation of sofuspovir containing DAA regien expected insult on kidneyOther
to use different kidney biomarkers to evaluate acute kidney damage after using sofuspovir containing DAA regimen in treatment of HCV
| Study group | Role | What they receive |
|---|---|---|
| HCV infected patients with non-elevated sCr than basal levels | Other | 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 Receives: Other: evaluation of sofuspovir containing DAA regien expected insult on kidney |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from the start to 6 months later
Secondary outcomes (1)
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
Measured: from the starting of treatment till the 3-months follow up after the end of the treatment regimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start1 Jul 2019
- Primary completion30 Apr 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Investigate the Renal Effect of DAAs on Egyption Patients After Completion of TreatmentStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalia K. Zaafar, Cairo University
- Investigators
- Dalia Zaafar, PhD, Principal investigator, Lecturer of pharmacology and toxicology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267458
- Sponsor's protocol ID
- 15-2019
- Status last verified
- Feb 2020
- First submitted
- 26 Jan 2020
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Prevalence of Acute Kidney Injury in Patients With Chronic Hepatitis c Virus Receiving Sofuspovir Containing Direct Acting Antiviral Therapy
- ClinicalTrials.gov ID
- NCT04267458
- Acronym / sponsor ID
- 15-2019
- Keywords
- DAA, HCV, egyption patients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCV infected patients with non-elevated sCr than basal levels | Other | Other: evaluation of sofuspovir containing DAA regien expected insult on kidneya group of egyption patients with HCV infection with non-elevated sCr than basal levels and treated with sofuspovir as an direct acting antiviral drug |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients suffering from HCV
- male or female
- easy to treat naive patients
Key exclusion criteria (4 listed)
- pregnant women
- seffering from HBV
- diffecult to treat
- other comorbodities as heart diseases or COPD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| evaluation of sofuspovir containing DAA regien expected insult on kidneyto use different kidney biomarkers to evaluate acute kidney damage after using sofuspovir containing DAA regimen in treatment of HCV | Other | HCV infected patients with non-elevated sCr than basal levels |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
soha hassanin, PhD contact
Dalia Zaafar, PhD principal investigator
Lecturer of pharmacology and toxicology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing evaluation of sofuspovir containing DAA regien expected insult on kidney in people with Investigate the Renal Effect of DAAs on Egyption Patients After Completion of Treatment, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dalia Zaafar, PhD (00201117922833, dr.moda88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.