Back to resultsHepatitis C in Renal Transplant Recipients
Primary Purpose
Chronic Hepatitis C-virus Infection, Renal Transplantation
Status
Unknown status
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
tacrolimus-cyclosporine A
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C-virus Infection focused on measuring chronic hepatitis C-virus infection, renal transplantation, glucose tolerance, immunosuppression
Eligibility 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
Sites / Locations
- Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
tacrolimus-cyclosporine A
Arm Description
conversion of immunosuppression from tacrolimus to cyclosporine A in hepatitis C-positive renal transplant recipients
Outcomes
Primary Outcome Measures
change in Hepatitis C-virus load at 12 weeks
Secondary Outcome Measures
change in oral glucose insulin sensitivity (OGIS) index at 12 weeks
change in serum hepcidin levels at 12 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02108301
Brief Title
Hepatitis C in 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 Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Dr. Alice Schmidt
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C-virus Infection, Renal Transplantation
Keywords
chronic hepatitis C-virus infection, renal transplantation, glucose tolerance, immunosuppression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
tacrolimus-cyclosporine A
Arm Type
Experimental
Arm Description
conversion of immunosuppression from tacrolimus to cyclosporine A in hepatitis C-positive renal transplant recipients
Intervention Type
Drug
Intervention Name(s)
tacrolimus-cyclosporine A
Intervention Description
conversion of immunosuppression from tacrolimus to cyclosporine A in hepatitis C-positive renal transplant recipients
Primary Outcome Measure Information:
Title
change in Hepatitis C-virus load at 12 weeks
Time Frame
one day before and 4, 8 and 12 weeks after the conversion
Secondary Outcome Measure Information:
Title
change in oral glucose insulin sensitivity (OGIS) index at 12 weeks
Time Frame
one day before and 12 weeks after the conversion
Title
change in serum hepcidin levels at 12 weeks
Time Frame
one day before and 12 weeks after the conversion
Other Pre-specified Outcome Measures:
Title
serum creatinine levels
Time Frame
12 weeks
Title
serum glutamic-pyruvic transaminase concentrations
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
26735686
Citation
Handisurya A, Kerscher C, Tura A, Herkner H, Payer BA, Mandorfer M, Werzowa J, Winnicki W, Reiberger T, Kautzky-Willer A, Pacini G, Saemann M, Schmidt A. Conversion from Tacrolimus to Cyclosporine A Improves Glucose Tolerance in HCV-Positive Renal Transplant Recipients. PLoS One. 2016 Jan 6;11(1):e0145319. doi: 10.1371/journal.pone.0145319. eCollection 2016.
Results Reference
derived
Learn more about this trial
Hepatitis C in Renal Transplant Recipients
We'll reach out to this number within 24 hrs