Hepatitis C in Renal Transplant Recipients

April 10, 2014 updated by: Prof. Dr. Alice Schmidt

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tacrolimus-cyclosporine A
conversion of immunosuppression from tacrolimus to cyclosporine A in hepatitis C-positive renal transplant recipients
Drug: tacrolimus-cyclosporine A
conversion of immunosuppression from tacrolimus to cyclosporine A in hepatitis C-positive renal transplant recipients

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
change in oral glucose insulin sensitivity (OGIS) index at 12 weeks
Time Frame: one day before and 12 weeks after the conversion
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
one day before and 12 weeks after the conversion

Other Outcome Measures

Outcome Measure
Time Frame
serum creatinine levels
Time Frame: 12 weeks
12 weeks
serum glutamic-pyruvic transaminase concentrations
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. Alice Schmidt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

April 1, 2014

First Submitted That Met QC Criteria

April 6, 2014

First Posted (Estimate)

April 9, 2014

Study Record Updates

Last Update Posted (Estimate)

April 11, 2014

Last Update Submitted That Met QC Criteria

April 10, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK477/2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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