Hepatitis C in renal transplant recipients – Safety and efficacy of a conversion of immunosuppression to high-dose cyclosporine A and its impact on HCV-replication, parameters of liver function and glucose tolerance. An open label trial.

Phase 1

Conditions: renal transplant recipients with hepatitis C
MedDRA version: 14.1Level: LLTClassification code 10057394Term: Hepatitis C positiveSystem Organ Class: 10022891 - Investigations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2011-002267-26-AT

Lead Sponsor: Medizinische Universität Wien

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

- Written informed consent
- Prior renal transplantation with a current tacrolimus-based immunosuppressive regimen
- Hepatitis C-infection
- Age 18-70 years

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

- Current hemodialysis or peritoneal dialysis
- Pregnancy or breastfeeding
- Known CsA-intolerance

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the impact of a conversion to a cyclosporine A-based immunosuppressive regimen on HCV-replication and parameters of liver function in renal transplant recipients ;Secondary Objective: To assess the impact of a conversion to a cyclosporine A-based immunosuppressive regimen on parameters of insulin sensitivity and insulin secretion in renal transplant recipients ;Primary end point(s): HCV-RNA;Timepoint(s) of evaluation of this end point: 12 weeks after the conversion of immunosuppression from a tacrolimus- to a cyclosporine a-based regimen

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): liver transaminases, fibroScan-Indices, IL28-SNP, vitamin D, parameters of insulin sensitivity and insulin secretion, plasma adipokine levels<br>;Timepoint(s) of evaluation of this end point: 12 weeks after the conversion of immunosuppression from a tacrolimus- to a cyclosporine a-based regimen