Hepatitis C in Renal Transplant Recipients
Phase 4
- Conditions
- Chronic Hepatitis C-virus InfectionRenal Transplantation
- Interventions
- Drug: tacrolimus-cyclosporine A
- Registration Number
- NCT02108301
- Lead Sponsor
- Prof. Dr. Alice Schmidt
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- written informed consent
- prior renal transplantation
- current tacrolimus-based immunosuppressive regimen
- hepatitis C-infection
- age 18-70 years
Exclusion Criteria
- current hemodialysis or peritoneal dialysis
- pregnancy or breastfeeding
- known contraindication for cyclosporine A-treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description tacrolimus-cyclosporine A tacrolimus-cyclosporine A conversion of immunosuppression from tacrolimus to cyclosporine A in hepatitis C-positive renal transplant recipients
- Primary Outcome Measures
Name Time Method change in Hepatitis C-virus load at 12 weeks one day before and 4, 8 and 12 weeks after the conversion
- Secondary Outcome Measures
Name Time Method change in oral glucose insulin sensitivity (OGIS) index at 12 weeks one day before and 12 weeks after the conversion change in serum hepcidin levels at 12 weeks one day before and 12 weeks after the conversion
Trial Locations
- Locations (1)
Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis
🇦🇹Vienna, Austria