Effect of Switching to Certican® in Viremia of Hepatitis C Virus in Adult Renal Allograft Recipients
- Conditions
- Hepatitis CRenal Allograft
- Interventions
- Registration Number
- NCT01469884
- Brief Summary
Compare the viral load of hepatitis c virus in patients converted to certican versus patients who are maintained on calcineurin inhibitor.
- Detailed Description
The infection by hepatitis C virus (HCV) is the leading cause of chronic liver disease in renal transplant recipients.
The prevalence of pretransplantation anti-HCV is 11% to 49%. The impact of HCV infection on patient survival after renal transplant remains controversial. Some studies also showed that patients undergoing renal transplantation anti-HCV positive are associated with a reduction in graft and patient survival.Chronic infection of HCV is associated with an increased number of infections.
In HCV positive renal transplant patients have been shown that there is an increase from four to seven times in HCV viremia after transplantation compared to pretransplant.
To prevent viral replication, immunosuppression must be adapted, involving a balance between control of viral replication and rejection.
Biochemically, the NS5A protein has been linked to increased replication of the hepatitis C virus through p70S6K phosphopeptides. Sirolimus as inhibitor of pathway mTOR/p70S6K reduced in vivo phosphorylation of NS5A phosphopeptides and thus viral replication. Moreover, the mTOR protein has been proven in vitron to have a protective role against apoptosis in HCV infected cells (WAGNER et al., 2010).
Wagner et al. (2010) showed a beneficial effect of sirolimus on viral recurrence monitored by transaminases and viral load as well as by histological data. They also reported the improved survival after liver transplantation due to hepatitis C for patients receiving sirolimus rather than calcineurin inhibitor-based regimens.
In the literature there have already been reported good virological control of HCV among liver transplant recipients after conversion to SRL and the reduction of hepatitis C virus recurrence (GALLEGO et al., 2009; BENEDETTOET al., 2010).
Everolimus has shown a potent inhibitor of mTOR and has been widely used as an immunosuppressive agent in kidney transplant, but no reported effects on HCV progression was found in the literature.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tacrolimus or Cyclosporine Cyclosporine Arm2(maintained):Tacrolimus or Cyclosporine+mycophenolate+prednisone Tacrolimus or Cyclosporine Tacrolimus Arm2(maintained):Tacrolimus or Cyclosporine+mycophenolate+prednisone Certican® Everolimus Arm1(conversion):Certican®+mycophenolate+prednisone
- Primary Outcome Measures
Name Time Method Change from baseline in viral load of hepatitis C virus at 12 months after randomization. Baseline,Months 3, 6, 9 and 12 after randomization HCV viremia will be measured by polymerase chain reaction (PCR)
- Secondary Outcome Measures
Name Time Method Incidence of significant infections Weeks1, 2, 3 and months 1, 3, 6,9 and 12 after randomization During the study visits the patient will be evaluated by a doctor and it will perform blood tests to assess their clinical conditions.
Development of proteinuria Months 1, 3, 6, 9 and 12 after randomization Spot urine sample for protein and creatinine will be performed.
Development of malignance Weeks 1, 2, 3 and months 1, 3, 6, 9 and 12 after randomization Medical evaluation will be performed during the protocol visits and if necessary biopsy and exams of imaging to confirm any suspected.
Development of dyslipidemia Months 1, 3, 6, 9 and 12 after randomization Lipid levels: total cholesterol, HLD, LDL and triglycerides will be performed.
Development of liver impairment Months 1, 3, 6, 9, and 12 after randomization Blood chemistry: TGO/AST, TGP/ALT , GGT and alkaline phosphatase will be performed.
Development of post-transplant diabetes Months 1, 3, 6, 9 and 12 Blood chemistry: Glucose will be performed.
Development of hypertension Weeks 1, 2, 3 and months 1, 3, 6, 9 and 12 after randomization Vital signs will be performed
Graft loss survival Weeks 1, 2 , 3 and months 1, 3 ,6, 9 and 12 after randomization Graft survival will be evaluated by our team doctor.
Patient survival Weeks 1, 2, 3 and months 1, 3, 6, 9 and 12 after randomization Subject survival will be evaluated by our team doctor
Incidence of acute allograft rejection Weeks 1, 2, 3, months 1, 3, 6, 9 and 12 after randomization All patients will perform at least 07 protocol visits and should be performed renal biopsy during screening phase and during the follow up if present renal dysfunction or proteinuria.
Trial Locations
- Locations (1)
Irmandade Da Santa Casa de Misericórdia de Porto Alegre
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil