Overview

This trial is active, not recruiting.

Conditions chronic hepatitis c-virus infection, renal transplantation
Treatment tacrolimus-cyclosporine a
Phase phase 4
Sponsor Prof. Dr. Alice Schmidt
Start date December 2011
End date June 2013
Trial size 30 participants
Trial identifier NCT02108301, EK477/2011

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
conversion of immunosuppression from tacrolimus to cyclosporine A in hepatitis C-positive renal transplant recipients
tacrolimus-cyclosporine a
conversion of immunosuppression from tacrolimus to cyclosporine A in hepatitis C-positive renal transplant recipients

Primary Outcomes

Measure
change in Hepatitis C-virus load at 12 weeks
time frame: one day before and 4, 8 and 12 weeks after the conversion

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Medical University of Vienna.