CKD With Hepatitis CNCT02563665
Safety and Efficacy of Sofosbuvir Based Antiviral Regimen for Treating Hepatitis C in Patients With Moderate to Advanced Chronic Kidney Disease and Patients Receiving Renal Replacement Therapy
An observational study of CKD With Hepatitis C, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
All patients with chronic kidney disease (stages 3, 4 and 5) and chronic dialysis patients with HCV infection attending nephrology and Hepatology OPD or getting outpatient dialysis at the dialysis unit of ILBS. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CKD With Hepatitis C
- How many people
- 0 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2015to Sep 2017
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with chronic kidney disease (stages 3, 4 and 5) and chronic dialysis patients with Hepatitis C infection attending nephrology and Hepatology OPD (Out Patient Department) or getting outpatient dialysis at the dialysis unit of Institute of Liver and Biliary Sciences.
Who may be able to join
- Patients with moderate to severe renal dysfunction (CKD stage 3, 4, 5) and chronic dialysis patients
- Patients consented for the study protocol by signing the informed consent.
Who cannot join
- Age less than 18 years
- Confirmed pregnancy
- HCV-HIV Co infection
- HBV-HCV co infection
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: A Prospective Study on Safety and Efficacy of Sofosbuvir Based Antiviral Regimen for Treating Hepatitis C in Patients With Moderate to Advanced Chronic Kidney Disease and Patients Receiving Renal Replacement Therapy
All patients with chronic kidney disease (stages 3, 4 and 5) and chronic dialysis patients with HCV infection attending nephrology and Hepatology OPD or getting outpatient dialysis at the dialysis unit of ILBS.
- Conditions
- CKD With Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| advanced chronic kidney disease | Subjects on dialysis with GFR (Glomerular Filtration Rate) > 30 | |
| Renal replacement therapy. | Subjects who are not on dialysis with GFR (Glomerular Filtration Rate) < 15 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Virologic Response 24 defined as HCV RNA <Lower Level of Qunatification 24 weeks after discontinuation of therapy.
Measured: 1 year
Secondary outcomes (1)
number of adverse Events in both groups
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Why it stopped: Lack of funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKD With Hepatitis CStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Suman Lata Nayak, DM, Principal investigator, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563665
- Sponsor's protocol ID
- ILBS-HCKD/001/SOFO/2015
- Status last verified
- Oct 2016
- First submitted
- 26 Sep 2015
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on Safety and Efficacy of Sofosbuvir Based Antiviral Regimen for Treating Hepatitis C in Patients With Moderate to Advanced Chronic Kidney Disease and Patients Receiving Renal Replacement Therapy
- ClinicalTrials.gov ID
- NCT02563665
- Acronym / sponsor ID
- ILBS-HCKD/001/SOFO/2015
- Conditions
- CKD With Hepatitis C
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of funds
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 30 Sep 2015 (estimated)
- 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.
All patients with chronic kidney disease (stages 3, 4 and 5) and chronic dialysis patients with HCV infection attending nephrology and Hepatology OPD or getting outpatient dialysis at the dialysis unit of ILBS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| advanced chronic kidney disease | – | –Subjects on dialysis with GFR (Glomerular Filtration Rate) > 30 |
| Renal replacement therapy. | – | –Subjects who are not on dialysis with GFR (Glomerular Filtration Rate) < 15 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with chronic kidney disease (stages 3, 4 and 5) and chronic dialysis patients with Hepatitis C infection attending nephrology and Hepatology OPD (Out Patient Department) or getting outpatient dialysis at the dialysis unit of Institute of Liver and Biliary Sciences.
Key inclusion criteria (2 listed)
- Patients with moderate to severe renal dysfunction (CKD stage 3, 4, 5) and chronic dialysis patients
- Patients consented for the study protocol by signing the informed consent.
Key exclusion criteria (4 listed)
- Age less than 18 years
- Confirmed pregnancy
- HCV-HIV Co infection
- HBV-HCV co infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sustained Virologic Response 24 defined as HCV RNA <Lower Level of Qunatification 24 weeks after discontinuation of therapy.
Time frame: 1 year
1 secondary outcome
number of adverse Events in both groups
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
Related trials for CKD With Hepatitis C
Not yet recruitingPhase 2/3
Treatment of CKD Patients With HCV
HCV Infection ( Genotype 4) in CKD Patients
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.
Dr Suman Lata Nayak, DM principal investigator
Institute of Liver and Biliary Sciences, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CKD With Hepatitis C, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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 2 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: withdrawn, as of the sponsor's last update on 5 Nov 2019. 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 India. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained Virologic Response 24 defined as HCV RNA <Lower Level of Qunatification 24 weeks after discontinuation of therapy. (time frame: 1 year). 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 5 Nov 2019.