Chronic Hepatitis C-virus InfectionPhase 4NCT02108301
Hepatitis C in Renal Transplant Recipients
A Phase 4 study testing tacrolimus-cyclosporine A in people with Chronic Hepatitis C-virus Infection and Renal Transplantation, run by Prof. Dr. Alice Schmidt at 1 site in Austria.
Trial summary
The aim of the present trial is to evaluate whether the conversion of immunosuppression from tacrolimus to cyclosporine A induces changes in (i) hepatitis C-virus load, (ii) parameters of hepatic function and (iii) parameters of glucose tolerance in hepatitis C-positive renal transplant recipients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis C-virus Infection, Renal Transplantation
- What is being tested?
- tacrolimus-cyclosporine A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2011to Jun 2013
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- written informed consent
- prior renal transplantation
- current tacrolimus-based immunosuppressive regimen
- hepatitis C-infection
- age 18-70 years
Who cannot join
- current hemodialysis or peritoneal dialysis
- pregnancy or breastfeeding
- known contraindication for cyclosporine A-treatment
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis
Vienna, State of Vienna, 1090
About this study
Official title: Hepatitis C in Renal Transplant Recipients - Safety and Efficacy of a Conversion of Immunosuppression to High-dose Cyclosporine A and Its Impact on Hepatitis C Virus-replication, Parameters of Liver Function and Glucose Tolerance. An Open Label Trial.
The aim of the present trial is to evaluate whether the conversion of immunosuppression from tacrolimus to cyclosporine A induces changes in (i) hepatitis C-virus load, (ii) parameters of hepatic function and (iii) parameters of glucose tolerance in hepatitis C-positive renal transplant recipients.
- Being tested
- tacrolimus-cyclosporine A
- Keywords
- chronic hepatitis C-virus infection, renal transplantation, glucose tolerance, immunosuppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tacrolimus-cyclosporine ADrug
conversion of immunosuppression from tacrolimus to cyclosporine A in hepatitis C-positive renal transplant recipients
| Study group | Role | What they receive |
|---|---|---|
| tacrolimus-cyclosporine A | Experimental | conversion of immunosuppression from tacrolimus to cyclosporine A in hepatitis C-positive renal transplant recipients Receives: Drug: tacrolimus-cyclosporine A |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Hepatitis C-virus load at 12 weeks
Measured: one day before and 4, 8 and 12 weeks after the conversion
Secondary outcomes (2)
change in oral glucose insulin sensitivity (OGIS) index at 12 weeks
Measured: one day before and 12 weeks after the conversion
change in serum hepcidin levels at 12 weeks
Measured: one day before and 12 weeks after the conversion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startDec 2011
- Primary completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis C-virus InfectionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Alice Schmidt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. Alice Schmidt, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108301
- Sponsor's protocol ID
- EK477/2011
- Status last verified
- Apr 2014
- First submitted
- 1 Apr 2014
- Last updated
- 11 Apr 2014
- Results posted
- No
Publications
Handisurya A, Kerscher C, Tura A, Herkner H, Payer BA, Mandorfer M, Werzowa J, Winnicki W, Reiberger T, Kautzky-Willer A, Pacini G, Saemann M, Schmidt A. Conversion from Tacrolimus to Cyclosporine A Improves Glucose Tolerance in HCV-Positive Renal Transplant Recipients. PLoS One. 2016 Jan 6;11(1):e0145319. doi: 10.1371/journal.pone.0145319. eCollection 2016.
PubMed 26735686
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis C in Renal Transplant Recipients - Safety and Efficacy of a Conversion of Immunosuppression to High-dose Cyclosporine A and Its Impact on Hepatitis C Virus-replication, Parameters of Liver Function and Glucose Tolerance. An Open Label Trial.
- ClinicalTrials.gov ID
- NCT02108301
- Acronym / sponsor ID
- EK477/2011
- Keywords
- chronic hepatitis C-virus infection, renal transplantation, glucose tolerance, immunosuppression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Prof. Dr. Alice SchmidtUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jun 2013 (actual)
- First posted
- 9 Apr 2014 (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.
The aim of the present trial is to evaluate whether the conversion of immunosuppression from tacrolimus to cyclosporine A induces changes in (i) hepatitis C-virus load, (ii) parameters of hepatic function and (iii) parameters of glucose tolerance in hepatitis C-positive renal transplant recipients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tacrolimus-cyclosporine A | Experimental | Drug: tacrolimus-cyclosporine Aconversion of immunosuppression from tacrolimus to cyclosporine A in hepatitis C-positive renal transplant recipients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- written informed consent
- prior renal transplantation
- current tacrolimus-based immunosuppressive regimen
- hepatitis C-infection
- age 18-70 years
Key exclusion criteria (3 listed)
- current hemodialysis or peritoneal dialysis
- pregnancy or breastfeeding
- known contraindication for cyclosporine A-treatment
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 |
|---|---|---|
| tacrolimus-cyclosporine Aconversion of immunosuppression from tacrolimus to cyclosporine A in hepatitis C-positive renal transplant recipients | Drug | tacrolimus-cyclosporine A |
Primary outcome
change in Hepatitis C-virus load at 12 weeks
Time frame: one day before and 4, 8 and 12 weeks after the conversion
2 secondary outcomes
change in oral glucose insulin sensitivity (OGIS) index at 12 weeks
Time frame: one day before and 12 weeks after the conversion
change in serum hepcidin levels at 12 weeks
Time frame: one day before and 12 weeks after the conversion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2014.
- Derived from this study: PubMed 26735686Handisurya A, Kerscher C, Tura A, Herkner H, Payer BA, Mandorfer M, Werzowa J, Winnicki W, Reiberger T, Kautzky-Willer A, Pacini G, Saemann M, Schmidt A. Conversion from Tacrolimus to Cyclosporine A Improves Glucose Tolerance in HCV-Positive Renal Transplant Recipients. PLoS One. 2016 Jan 6;11(1):e0145319. doi: 10.1371/journal.pone.0145319. eCollection 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 tacrolimus-cyclosporine A in people with Chronic Hepatitis C-virus Infection and Renal Transplantation, run by Prof. Dr. Alice Schmidt at 1 site in Austria.
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 5 inclusion and 3 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 11 Apr 2014. 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 Austria. 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?
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?
change in Hepatitis C-virus load at 12 weeks (time frame: one day before and 4, 8 and 12 weeks after the conversion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02108301, which also lists 1 linked publication.
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 11 Apr 2014.