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NCT02108301 Clinical Trial

Hepatitis C in Renal Transplant Recipients

Renal Transplantation Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02108301
Other study ID # EK477/2011
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received April 1, 2014
Last updated April 10, 2014
Start date December 2011

Study information
Verified date April 2014
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: EthikkommissionAustria: Agency for Health and Food Safety
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 30
Est. completion date
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

Drug:
• tacrolimus-cyclosporine A
conversion of immunosuppression from tacrolimus to cyclosporine A in hepatitis C-positive renal transplant recipients

Locations
Country Name City State
Austria Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis Vienna

Sponsors (1)
Lead Sponsor Collaborator
Prof. Dr. Alice Schmidt

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Other serum creatinine levels 12 weeks Yes
Other serum glutamic-pyruvic transaminase concentrations 12 weeks Yes
Primary change in Hepatitis C-virus load at 12 weeks one day before and 4, 8 and 12 weeks after the conversion No
Secondary change in oral glucose insulin sensitivity (OGIS) index at 12 weeks one day before and 12 weeks after the conversion No
Secondary change in serum hepcidin levels at 12 weeks one day before and 12 weeks after the conversion No
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