Hepatitis C in Renal Transplant Recipients

Condition(s) targeted: Chronic Hepatitis C-virus Infection; Renal Transplantation

Intervention: tacrolimus-cyclosporine A (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Prof. Dr. Alice Schmidt

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.

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.

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: change in Hepatitis C-virus load at 12 weeks

Secondary outcome:

change in oral glucose insulin sensitivity (OGIS) index at 12 weeks

change in serum hepcidin levels at 12 weeks

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis, Vienna 1090, Austria

Starting date: December 2011
Last updated: April 10, 2014